Free Arts! Day At The Art And Culture Center/Hollywood January 15, 2025 Share New York Times Best-Selling Author Brad Meltzer will be at the Art and Culture Center/Hollywood for the opening of the Early Voices: Xavier Riddle Exhibition during our Free Arts! Day. Residents and visitors alike can enjoy free admission on Sunday, January 19th, from Noon 12:00 p.m. – 4:00 p.m., view new arts exhibitions and create Xavier Riddle themed drop-in art-making activities exploring how you can change the world and celebrate the people who inspire you. Meltzer will engage guests, from 2:00 p.m. – 3:00 p.m., with a presentation of his Xavier Riddle and the Secret Museum And Ordinary People Change the World television and book series respectively, followed by a Q & A. The first 50 kids to arrive will receive a complimentary autographed book from the Ordinary People Change the World Series, featuring the tales of Frida Kahlo, Oprah, I.M. Pei, and Sonia Sotomayor. Visitors can also purchase Meltzer’s newest release, hot off the press, The JFK Conspiracy. The first 30 buyers will have their book personally signed. The fun continues with the opening of the Early Voices: Xavier Riddle exhibition in the Center’s Community Gallery featuring artwork from 2nd grade students at Avant Garde Academy, Collins Elementary, Driftwood Elementary and Hollywood Central Elementary. The Early Voices program was designed to foster creativity and improve literacy. Memorial Healthcare System VP of Community Services, Tim Curtin, remarked, “We are proud to support this initiative in collaboration with Broward Reads, which has impacted over 2,000 students. Studies show that the level of a child’s literacy by 3rd grade is the greatest predictor of life success and has significant influence on their overall well-being.” Guests will also be treated to an early preview of In My Own World: The NAEMI Collection Exhibition, on view until February 23rd. In collaboration with National Art Exhibitions of the Mentally Ill (NAEMI), this presentation brings awareness to the issues of Mental Health and well-being. NAEMI’s is a Non-Profit organization whose mission is to discover, study, promote, exhibit, and preserve the art of people recovering from Mental Illness. The Early Voices: Xavier Riddle Exhibition is presented in Partnership with the Museum of Discovery and Science (MODS) and Broward Museum Alliance. MODS will be presenting the Xavier Riddle and the Secret Museum: The Exhibit will run from January 17th to May 11th. The Art and Culture Center/Hollywood Free Arts! Day takes place on the third Sunday of every month exploring a different medium through drop-in art making activities designed to appeal to all ages. About the Art and Culture Center/Hollywood The Art and Culture Center/Hollywood is a 501(c)(3) Non-Profit Organization supported in part by its members, admissions, private entities, the City of Hollywood, the Broward County Board of County Commissioners as recommended by the Broward Cultural Council; and the State of Florida, Department of State, Division of Cultural Affairs, the Florida Council on Arts and Culture. We welcome donations from all members of the community who wish to support our work. < Previous News Next News >

Here Comes Santa Claus At Gulfstream Park Village! South Florida’s Ultimate Home Store, Entertainment And Restaurant Destination Welcomes Visits From Santa This Holiday Season Thu Nov 24 2022 17:08:00 GMT+0000 (Coordinated Universal Time)

Government Ethics: With Power and Authority Comes Responsibility and Obligations By Larisa Svechin, Sunny Isles Beach Mayor - www.sibfl.net May 31, 2023 Share Ethical government is different from everyday ethical behavior; it is not about being “good” or a “person of integrity.” Behavior that is commendable outside of government, like helping a family member get a post or repaying a favor one has been given, is considered wrong in a government setting. Government ethics is the area of decision-making involving conflicts between the obligations government officials have toward the public, and their obligations to themselves and their family, their business associates, and others with whom they have a special relationship (known as “conflicts of interest”). It is not just the reality of these responsibilities and actions, but also the appearance of these obligations and relationships. As elected officials, we make certain sacrifices to show the community that we are acting in the best interest of the community rather than for ourselves and those we hold as special. To some officials, this seems unfair. After all, elected officials have already sacrificed, serving as low-paid legislators and giving up their precious time for the community. Why should they have to sacrifice more? The reason is obvious. With power and authority comes responsibility and obligations. Obligations require sacrifice. It is critical officials recognize that government ethics is not only beneficial to a community’s residents, but also to them. It protects the mayor and commission by providing rules and best practices, allowing us to deal with our obligations to others in situations that may be very uncomfortable. It takes just one decision that appears self-serving to lose the respect and trust of the community. Government ethics’ primary goal is to promote the public’s trust in their elected officials, to put their personal interests aside in favor of the public interest. Without this trust, residents tend not to participate; they feel disconnected from their government and start to believe the government is designed to benefit the members of the commission, rather than serve the community. The opposite of trust is not distrust, which we need to keep our representatives accountable, but a lack of trust. A lack of trust causes people not to accept their government’s decisions as fair. A democratic government does not thrive when there is a lack of trust in those who govern it. As your Mayor, I, along with the commission, am tasked with preserving institutional rather than personal integrity. In short, we are held to a higher ethical standard. If you have any questions, feel free to contact Mayor Larisa Svechin at: mayor@sibfl.net or: 305.792.1753. < Previous News Next News >

Gulfstream Park Village Puts Fun on the Map with Live Music, Exciting Racing and New Destination, Carousel Club Thu Mar 24 2022 04:09:00 GMT+0000 (Coordinated Universal Time)

Trolls Are Coming To Peace Park: You'll Be Singing And Dancing All Evening Long March 21, 2024 Share Enjoy a beautiful South Florida evening with a family-friendly movie outdoors, so bring blankets and/or lawn chairs for seating. Next up in the City of Aventura’s Movie Night series is “Trolls Band Together.” The animated film will be held at Peace Park located at: 3200 Northeast 188th Street, Aventura, Florida 33180. Food Trucks will be on the premises for the duration of the event. Please note that food deliveries, alcoholic beverages and pets are NOT permitted in the park. Movie Night Schedule: • “Trolls Band Together” on Saturday, April 20th, 2024 • Ticket Reservations are open Friday, April, 5th, 2024 at 10:00 a.m. • Wristband Pick Up: Monday, April 15th – Friday, April 19th 9:00 a.m. – 12:00 p.m. and 6:30 p.m. – 8:30 p.m. • Park opens at 7:00 p.m., and the movie starts at 8:00 p.m. The Movie Get ready for an all-star family reunion like no other in the next chapter of DreamWorks Animation's Blockbuster Musical Franchise! As Poppy: Anna Kendrick grows closer to her now boyfriend Branch: Justin Timberlake, she discovers his secret past as a member of her favorite boy band, BroZone, with his four estranged brothers. When Branch's bro Floyd is kidnapped for his musical talents by a pair of nefarious popstars, Branch and Poppy embark on an action-packed journey to reunite the other brothers and rescue Floyd. Along the way Poppy uncovers a family secret of her own, a long-lost sister named Viva: Camila Cabello. Trolls Band Together features the franchise's signature psychedelic joy-bomb of new and classic pop hits that will have you singing and dancing along over and over again! "Wow, Trolls Band Together is an absolute explosion of joy! Our family was dancing and singing along from the very beginning. This movie is like a party in a box, packed with vibrant colors, catchy music, and a heartwarming story that captivated both the kids and adults in our house. The animation is stunning, bringing the magical world of Trolls to life with even more brightness and flair. The music, as always, is a highlight, with new songs that are just as infectious as the classics. It's not just a film; it's an experience that lifts your spirits and gets your feet moving." Tickets: Ticket Reservations are Required for every individual and can be completed online only with a valid and existing account at: www.cityofaventura.com/ors - the City’s Online Registration System (ORS). The Cost is $2 Per Person. Everyone including young children and babies is Required to purchase a ticket. All tickets are Non-Transferable and cannot be duplicated! Each ticket can only be scanned once! Tickets will be attached to your receipt upon submission of payment. In order to enter the event, you must pick up your wristbands at the Community Recreation Center PRIOR to the day of the event. Please keep in mind everyone entering the event MUST have their wristband on, including young children and babies. Parking will be available at the Aventura City of Excellence School, located north of Peace Park. Additional parking will be available at the 10x Centre garage located on the west end of 188th Street. Guests are encouraged to arrive early to park and get settled in prior to show time. For more information, contact Founders Park at: (305) 466-0183. < Previous News Next News >

Changing The Lives of Students: A Pathway Through Education To Economic Success June 6, 2024 Share In July 2022, Cristo Rey Miami High School opened in North Miami and will serve over 400 students by 2025 across 9th-12th grades. Cristo Rey Miami is the 39th member of a nationwide network of private, Catholic schools utilizing an innovative educational model that combines rigorous academics with professional work experience. It is the only college-and-career preparatory high school in Miami exclusively providing hard-working students from families with limited resources a clear pathway through education to economic success. The Cristo Rey Network are the only high schools in the nation to offer four years of rigorous college-prep academics combined with professional work experience through its Corporate Work Study Program. The Miami High School location is the only college-and-career preparatory school in the South Florida community exclusively serving hard-working students from low-income families. The Corporate Work Study Program enables students to earn and pay for more than half of their tuition, gain valuable job experience, and prepare for future employment. How The Corporate Work Study Program Works: • Students work in a professional corporate environment five days each month to earn a majority of their tuition and gain valuable experience for life after college. • Students are transported to and from their work sites. • Students must attend a three-week Summer Success Institute, a job training/school prep program. During Cristo Rey Miami’s founding 2022-23 school year, Cristo Rey Miami students earned over $500,000 toward their education working at 18 partner companies. Cristo Rey Miami’s student population is a reflection of Miami’s diverse community and its immediate neighboring area - 48% Haitian, 30% Black and 22% Hispanic, with an average family household income of $37,000 (family of 4). For students tuition ranges from $100 - $750 annually based on each family's income, 30 - 40% of tuition is covered through one of the Florida Tax Credit Scholarships, 10% is covered by the contributed support of donors, and families contribute to the cost of education based on financial ability. “By providing high-quality, college-preparatory education, particularly for underserved communities, Cristo Rey Miami High School is changing lives,” said Griffin. “I am honored to support its innovative integration of academics with work experience to empower students with the skills they need to be successful.” Growing To Meet The Needs of The Community Cristo Rey Miami High School is South Florida’s only college-and-career preparatory high school exclusively serving students from families with limited economic resources. With the generous support of South Florida's philanthropic leaders, the school is celebrating a major milestone in its “Built for the Future” capital campaign, reaching 90% of its $16 million goal. “As we celebrate meeting this significant goal in our capital campaign, we extend our deepest gratitude to our donors, partners, and the entire South Florida community,” said Amelie Ferro, President and CEO, Cristo Rey Miami High School. Continuing its trajectory of growth and excellence, Cristo Rey Miami High School is proud to announce a transformative gift of $2.1 million from Griffin Catalyst, the civic engagement initiative of Citadel Founder and CEO Kenneth C. Griffin. This generous donation supports the construction of a 38,000 square-foot academic building necessary to accommodate a full student body of approximately 425 students and lays the groundwork for future strategic endeavors. Griffin Catalyst’s donation serves as a testament to the success of Cristo Rey’s education model. With students attending college at higher rates than any other socio-demographic group and graduating from college at two times the rate of their peer group, Cristo Rey schools equip students from low-income backgrounds to excel in college and beyond. The success of Cristo Rey Miami capital campaign would not be possible without the generous support of South Florida's donor community. Key supporters such as the Miguel B. Fernandez Family Foundation, the Anthony R. Abraham Foundation, and the Smith and Shay families have played a pivotal role in realizing the school’s vision, demonstrating a shared commitment to empowering future generations through education. “Together, we are building a brighter future for our students, empowering them to realize their full potential and become leaders of tomorrow.” said Amelie Ferro. Cristo Rey Miami prepares students to enter and graduate from college by providing transformative learning opportunities both in the classroom and in corporate offices across Miami. A key element to the curriculum is the four-year, integrated Corporate Work Study Program (CWSP). Beginning freshman year, every student takes a full load of college preparatory coursework while also working five days each month in a professional office setting. The CWSP enables students to earn and pay for more than half of their tuition, gain professional work experience, cultivate a strong network of relationships, and realize the relevance of higher education to career goals. The Cristo Rey model has proven highly successful, graduating 25,800 students nationwide. Cristo Rey students enroll in college at higher rates than high and low-income populations and earn a bachelor's degree at twice the rate of their peers. For more information on Cristo Rey Miami High School, please visit: www.cristoreymiami.org . < Previous News Next News >

How Does Sleep Affect Your Weight? We Asked A Husband-And-Wife Team Of Medical Experts Thu Jul 25 2024 16:15:00 GMT+0000 (Coordinated Universal Time)

Five Steps To Grief Recovery: Because Grief Is Painful, We Sometimes Have A Tendency To Ignore Or Deny It Thu Aug 12 2021 04:07:00 GMT+0000 (Coordinated Universal Time)

Digging Up The Past: Looking Back 2,000 Years In Florida May 4, 2023 Share In recognition of National Hurricane Preparedness Week, which is April 30 to May 6 this year, learn how scientists are looking back thousands of years to gain a better understanding of hurricane patterns and how climate change could impact future storm activity. Knowing what has happened in the past gives insight on potential storm intensity and occurrence in the future. The U.S. Geological Survey is working with several partners to capture real-world data and identify the frequency and strength of past storms that weren’t previously studied. One effort led by the USGS looked back 2,000 years at hurricanes in Northwest Florida. During that time period, local climate conditions – including sea surface temperatures in portions of the Gulf of Mexico and northern Atlantic Ocean – were similar to today and what is anticipated in the future. The reasons for warming differ between the two time periods though, as past conditions were due to natural factors such as changes in the sun’s radiation, and more recent warming is primarily due to human activities. The USGS research suggests that existing records of recent storms may underrepresent how often powerful hurricanes have made landfall in northwest Florida. The research also supports forecasts by organizations such as the National Oceanic and Atmospheric Association that the number of intense hurricanes could increase in the future in parts of the Gulf of Mexico and Atlantic Ocean as oceans warm. This science can help improve hurricane forecasts and inform policy makers and managers as they prepare adaptation and mitigation plans to protect people, infrastructure and the environment. Studying the past provides a new baseline context and perspective of storm activity as well as new insight on how the climate and other environmental factors can influence hurricanes. Powerful Hurricanes That Weren’t Previously Studied In Florida “Most existing records on hurricanes that are used to help forecast storms date back to 1851, which is just over 170 years ago, and our research is looking beyond that by several thousands of years,” said USGS Research Geologist Jessica Rodysill. “We are collecting sediment from below the Earth’s surface and analyzing those samples to learn about hurricane occurrence over a long period.” The USGS-led study in Florida identified several strong Hurricanes, reaching Category 4 or 5 levels, that made landfall between the years 650 and 1250, 800 to 1,400 years ago. Prior to this research, Hurricane Michael in 2018 was the only storm stronger than Category 3 known to make landfall on the Florida Panhandle. It was a Category 5 Hurricane and resulted in the loss of 59 lives and $25 Billion in damages across the Southeastern U.S. “With additional data, the organizations developing climate and hurricane models can build more robust projections on what types of storms could impact Northwest Florida and nearby coasts,” said Rodysill. “Since this research focuses on real storms during warm periods, forecast models can be tested and validated to see if they produce scenarios that align with past events.” Future Intense Hurricanes In Parts Of The Gulf Of Mexico And Atlantic Ocean: The enhanced hurricane activity 800 to 1,400 years ago coincided with warmer sea surface temperatures in certain parts of the Gulf of Mexico and northern Atlantic Ocean. Temperatures in those oceans, where hurricanes typically form, are anticipated to warm over the next century to similar levels. Existing forecasts by NOAA and other organizations predict that the frequency of powerful hurricanes could increase in those locations, and other places across the globe, due to factors such as warming ocean temperatures. The research by the USGS and partners provides additional evidence to support those hurricane forecasts for portions of the Gulf of Mexico and Northern Atlantic Ocean, as scientists found strong hurricanes occurred in those areas when sea surface temperatures were warmer in the past. Future storms, however, will likely depend on a range of other factors such as atmospheric temperatures, the thickness of warm surface water and winds. The Role Of Climate: There are several conditions that support hurricane growth, and some of those can be influenced by the climate. The relationship between the climate and hurricane activity on long timescales is still not very well understood, which makes identifying hurricane trends challenging when taking climate change into account. In addition to warmer sea surface temperatures, the past hurricane activity in Northwest Florida coincided with a thicker layer of warm surface water in the Gulf of Mexico, known as the loop current. In addition, there were favorable winds that helped fuel and maintain storms, and those winds typically move toward areas with warmer air temperatures. While those and other conditions were already known to contribute to past storms within a hurricane season, studying the past allows for more detailed insight on those processes and influences. Long-Term Records Help Protect Communities: Studying long-term records can help guide decisions on the best ways to protect the nation’s coasts, which have become more vulnerable to storm inundation in recent years following the loss of protective barriers such as dunes and marshes following flooding from rising sea levels. There is also increased risk to people, infrastructure and the economy due to growing populations and development along shorelines. Scientists Dig In Lakes: In this research, sediment samples were collected from two locations in Coastal Florida; in Basin Bayou and a pond on the Bald Point Peninsula. Those locations are on the coast but far enough inland that they are mostly underlain by fine sediment, allowing for sand washed over from past storms to be easily identified. Scientists analyzed samples for characteristics such as the age, type, amount and thickness of sand deposits. Those observations gave insight on when a storm occurred in the past, its intensity, flooding extent, wave energy and other circumstances. The findings were compared to existing data by the USGS and others on the climate, including sea surface temperatures, during that time period. Wait, There’s More: USGS scientists are also involved in several projects across the country reconstructing an array of scenarios thousands to millions of years back, looking at more than just hurricanes. In addition to studying the past, the USGS provides data and insight on more recent storms and real-time monitoring of current events. The USGS science gives a perspective on Earth before humans frequently used instruments to measure the climate and weather. This research provides knowledge of past events that until now, nobody knew happened or why they occurred. < Previous News Next News >

Aventura Branch Library Happenings: Teens & Tweens Writing Club, Creative Kids, LEGO At The Library And Much More Wed May 15 2024 16:19:00 GMT+0000 (Coordinated Universal Time)

Justice For Kids Leads Heroic "Be Your Own Hero" Celebration At Joe DiMaggio Children’s Hospital South Florida Sun Times Apr 23, 2026 Justice For Kids Spearheaded A Powerful Mission Of Hope, As Real-Life Superheroes Descended Upon Joe Dimaggio Children’s Hospital. In A High-Energy Collaboration With The Hollywood Police Department (HPD) And Hollywood Fire Rescue (HFR), Justice For Kids® Sponsored The “Be Your Own Hero” Event, Designed To Celebrate The Incredible Resilience Of Pediatric Patients. The afternoon reached new heights as first responders—swapping their standard duties for superhero-inspired action—rappelled down the hospital’s exterior facade. Patients watched in awe from their windows and the hospital’s Child Life Zone as the "superheroes" waved to them during their descent, a spectacle intended to remind the children that they are the true protagonists of their own recovery stories. “Every child deserves to be empowered,” said Justin Grosz, Co-Founder of Justice for Kids®. “Justice for Kids® is honored to stand alongside our first responders and leaders in child healthcare to celebrate the resilience of these children and their families, as they fight their toughest battles with hero-level strength.” The excitement continued indoors at the Child Life Zone, where Justice for Kids® hosted a celebration for patients and their families. The festivities included snacks, games and a high-energy community rally atmosphere, where patients had the opportunity to interact directly with the first responders who had just performed the rappelling feat. The children also received and personalized their own superhero capes to symbolize their internal strength. One patient, Noah, noted that seeing the responders reminded him of his favorite hero, Superman. Another patient, Ana Lara, described the experience as "really cool and fun," despite the initial thrill of the height. Caitlin Stella, MPH, CEO of Joe DiMaggio Children’s Hospital, emphasized the importance of the partnership: “We are grateful to Justice for Kids and our local hometown heroes and first responders for helping to create this fun and special event for our kids. Hollywood Fire Rescue and Police are a critical part of our team here at Joe DiMaggio Children’s Hospital, always there for us when we need them. We are grateful for this opportunity for our children and families at the hospital to celebrate them.” The event served as a poignant reminder that while the first responders may have scaled the building, the real heroes are the children inside facing their health challenges with bravery every day. To view video from the day’s festivities, visit: https://youtu.be/xcIYFwNl18s About Justice for Kids Justice for Kids® (“JFK”), a division of Kelley Kronenberg, is a law practice dedicated to protecting abused, disabled and injured children nationwide who are harmed in child welfare and disability systems. Our mission is to be fierce advocates for children’s rights, to make personal injury recoveries for children injured, abused, or neglected by, or while in the care of, the governmental and private agencies that were supposed to protect them, and to drive systemic change in child welfare policy throughout the United States. Learn more at: www.justiceforkids.com . Justice for Kids partnered with the Hollywood Police and Fire departments to transform the facade of Joe DiMaggio Children’s Hospital into a superhero stage. The children also received and personalized their own superhero capes to symbolize their internal strength. Hollywood Fire Rescue and Police are a critical part of the team at Joe DiMaggio Children’s Hospital. Previous Next

A Statement From FDA Commissioner Marty Makary, M.D., M.P.H - 100 Days Of Embracing Gold-Standard Science, Transparency And Common Sense South Florida Sun Times Jul 16, 2025 As I Mark My Hundredth Day On The Job At The FDA, I’m Proud To Celebrate The Agency’s Accomplishments In The Bipartisan Effort To Make America Healthy Again. I Came Here With Big Questions: Why Does It Take Ten Years For A Drug To Reach Patients? How Can We Fix America’s Food Supply So It Is Not Filled With Harmful Chemicals And Additives? Why Are Childhood Chronic Diseases So Prevalent? We Are Taking Bold Action To Address These Big, Obvious Problems, And More, Which Have Been Staring At Us For Years. The FDA regulates products that account for 20% of all U.S. consumer spending, and our work impacts the lives of every American. Over the past 100 days, we’ve launched dozens of key initiatives across the full range of the FDA’s purview to help make food healthier for children and families, accelerate meaningful cures and treatments, and modernize the agency with transparency, gold-standard science and common sense. Highlights include: Food – Healthier Food for Children Fixing America’s Food Supply Petroleum-based food dye removal – Took action to phase out petroleum-based synthetic food dyes from the U.S. food supply, which are linked to numerous health risks. Improving infant formula – Continued the work of Operation Stork Speed by hosting an expert roundtable on infant formula and exploring new ways to bring additional and healthier options without ingredients like seed oils, added sugars and heavy metals to market. Food chemical review – Initiated a robust, transparent review of chemicals currently in the food supply, such as BHT, BHA and ADA; and expedited the review of chemicals currently under review, such as phthalates, propylparaben and titanium dioxide. GRAS reform – Exploring rulemaking to require “generally recognized as safe” (GRAS) submissions to FDA to stop industry’s long-standing practice of introducing ingredients into the food supply without FDA knowledge or oversight. Natural food dyes – Approved uses of three food colors derived from natural sources: Galdieria extract blue, butterfly pea flower extract and calcium phosphate, and initiated an accelerated review of other natural alternatives. Began revising broken dietary guidelines – Launched the Nutrition Regulatory Science Program in partnership with NIH to better address highly relevant questions for Americans’ health, such as the impact of ultra-processed foods and the effect of certain food additives. Defining ultra-processed foods – Will launch FDA/USDA request for data and information to help develop a uniform definition of ultra-processed foods, and industry roundtable, paving the way for additional study and action. More Meaningful Cures, Treatments and Diagnostics Accelerating Cures Reducing animal testing – Published a roadmap to transition away from animal testing for investigational new drug applications wherever possible and use more effective, human-relevant methods, such as organ-on-a-chip systems, advanced computer simulations, and pre-existing international data. Announced the intent to launch a pilot program in which select monoclonal antibody developers may pursue a primarily non-animal-based testing strategy, under close FDA consultation. Commissioner’s National Priority Voucher program – Announced a pilot program to expedite drug review processes from 10-12 months to 1-2 months following submission of a final application addressing U.S. national priorities, such as tackling a major health crisis or unmet public health need, increasing domestic drug manufacturing, and delivering more innovative cures for the American people. Revised COVID-19 Vaccine regulatory framework – Adopted a new evidence-based approach to COVID-19 booster approvals, replacing a one-size-fits-all regulatory framework and broad marketing authorizations with a risk-stratified approach that is already embraced by most doctors and parents. Updated labeling of mRNA shots to include new safety information about myocarditis and pericarditis. Addressed industry influence – Limited the circumstances where individuals employed at FDA-regulated companies, such as pharmaceutical companies, may serve as members of FDA advisory committees, where statutorily possible, to mitigate perceived conflicts of interest and strengthen integrity to the review process. CEO Listening Tour – Launched a six-city listening tour to meet directly with pharmaceutical and biotech executives, gathering honest feedback and big ideas to help the agency better accelerate cures and innovation. Cell and Gene therapy innovation – Engaged dozens of industry experts in a roundtable to shape actions that will ensure America leads at the forefront of innovation in this space. Removed restrictions on certain gene therapies – Removed REMS requirement for currently approved BCMA- and CD19-directed autologous chimeric antigen receptor CAR T cell immunotherapies, the first of many steps towards a more common-sense regulatory approach in this space. Diagnostics to empower healthy decisions – Cleared the first in vitro diagnostic device that tests blood to aid in diagnosing Alzheimer’s Disease. Initiated process to remove regulations on Laboratory Developed Tests (LDTs). Extended-release drug labeling change – Revised labeling on extended-release stimulants for ADHD treatment, cautioning parents and providers about the risks of adverse reactions, including weight loss, when used by children under six. Administration – Gold-Standard Science & Common Sense Protecting American Consumers Combatting illegal vapes – In collaboration with U.S. Customs and Border Protection, seized nearly $34 Million worth of illegal, youth-appealing e-cigarette products originating in China. Protecting the microbiome from fluoride tablets – Initiated action to remove concentrated ingestible fluoride prescription drug products for children from the market, which were not FDA-approved and have been shown to alter the gut microbiome. Examining talc – Hosted an expert panel to review the latest evidence and discuss potential health risks associated with talc used in food, drugs and cosmetics. Unannounced foreign inspections – Expanded the use of unannounced foreign inspections where appropriate, holding domestic and international drug manufacturers to the same high standard. Holistic inspection policy review – Began comprehensive review of the agency’s policies and practices for foreign inspections (including policies related to travel accommodations), ensuring the FDA remains the gold standard for regulatory oversight. Protecting American’s biological samples – Initiated action to review and, where necessary, halt clinical trials which involve exporting Americans’ living cells and DNA to labs in hostile countries, such as China, for genetic engineering and subsequent infusion back into U.S. patients. Enhancing drug importation – Fought high prescription drug prices by working to streamline the process by which states can pursue importation of safe, effective and affordable drugs from Canada, without imposing additional risk to public health and safety. Cracking down on falsified data – Discovered that third-party testing companies in China were producing falsified or otherwise invalid data; acted swiftly to protect the integrity of the premarket application process and the medical device supply chain. Fighting “gas station heroin” –Issued warning letters against companies distributing and selling unlawful tianeptine products, warned health care professionals and the general public about the extensive adverse events associated with tianeptine use. FDA import alerts – Updated several import alerts – for certain dietary supplements, cheeses, seafood, fish products and more – to help prevent illegal and unauthorized products flooding the U.S. market and risking American’s safety and health. Unleashing AI and Big Data AI-assisted review – Completed a successful first AI-assisted scientific review pilot, demonstrating that internal AI tools can greatly reduce the time reviewers spend on mundane tasks or non-productive busywork. Equipping reviewers with internal AI tools – Launched Elsa, a generative AI tool designed to help all FDA employees – from scientific reviewers to investigators – work more efficiently. Elsa is just an initial step in the FDA’s larger plans to integrate AI into agency processes. Building a better adverse event reporting database – Launched a comprehensive effort to consolidate disparate adverse event reporting databases, which will enable far more effective post-market monitoring of drug products. Modernization and Radical Transparency Transparent communications – Created FDA DirectExternal Link Disclaimer, a regular channel for communicating directly with the public through frequent, unscripted conversations with the FDA Commissioner about strategic updates and the thinking behind key agency decisions. Transparent agenda – In the Journal of the American Medical AssociationExternal Link Disclaimer, provided a clear outline of FDA leadership’s priorities for modernizing and improving the agency in the months ahead. Transparent decision making – Began publishing, to the greatest extent possible, decision letters issued in response to applications for new drugs and biological products. I’m excited by what the talented FDA team has been able to achieve in 100 days by embracing gold-standard science, radical transparency and common sense. This is just the beginning. We’ll continue to introduce initiatives to modernize the agency, protect consumers, bring more meaningful cures, treatments and diagnostics to patients, and make healthier food available for children, using the best science and data to Make America Healthy Again. Previous Next