By Karim Mikhail, Mike Davis, & Amy Comstock Rick – There is no substitute for sitting across the table from the people we serve. Recently we had the privilege of joining Acting Commissioner Kyle Diamantas, Acting Chief of Staff Lowell Zeta, and Deputy Commissioner Grace Graham for a roundtable discussion with 15 dedicated rare disease leaders.
By ShaAvhrée Buckman-Garner MD PhD & Mary Thanh Hai MD – FDA Advances Drug Development Innovation by Establishing ISTAND as Permanent Qualification Program – The FDA is excited to announce that our Innovative Science and Technology Approaches for New Drugs (ISTAND) pilot program has transitioned to a permanent drug development tool (DDT) Qualification Program.
By Robert M. Califf MD – One of the most alarming changes is the recent decline in life expectancy in our country, largely due to the cumulative impact of CCDs, combined with excessive rates of suicide, drug overdose and gun violence, and, of course, COVID-19. How can it be that our prowess in technology is not translating into better health and longevity for the American public?
By Robert M. Califf MD – Since launching our Overdose Prevention Framework in August, 2022, the FDA has taken some important steps to address the opioid overdose crisis. I’d like to catch up with you about opioid use disorder, and efforts we’re taking to mitigate this ongoing health condition.
By Robert M Califf MD & Kaveeta P. Vasisht MD PharmD – Thirty years ago, the U.S. Food and Drug Administration’s Office of Women’s Health was established to promote the inclusion of women in clinical trials and to provide leadership on topics related to the health of women.
From the FDA Blog – FDA has approved the 50th biosimilar, reflecting the markedly increased availability of biosimilar products—products that treat a wide range of chronic and severe illnesses, and which have already had an important impact on patient access!
By Robert Califf – At the FDA, we’ve been working for years to anticipate and prepare for the challenges of Artificial Intelligence (AI), and also to harness its potential. Some in the nonscientific community may be surprised by the seemingly sudden amount of attention on AI.
By Robert Califf – Recently I wrote about my recent trip to India, a trip largely motivated by the enormous need for coordinated effort on the common imperative in the U.S. and the rest of the world for readily available, high-quality generic drugs. I also relished the chance to visit a fascinating country and renew many friendships.
By Robert M. Califf MD – Biomedical and healthcare progress is dependent upon research that informs our decisions. The clinical trial is the most reliable method to determine the benefits and risks of interventions. The formation of ClinicalTrials.gov in February 2000 was a major step forward by providing a public record of trials.
By Peter Marks MD PhD & Daniel Jernigan MD MPH – Monitoring vaccine safety is an important responsibility shared by the Centers for Disease Control and Prevention and the U.S. Food and Drug Administration. And there’s no part of America’s vaccine safety system more talked about than the Vaccine Adverse Event Reporting System (VAERS).
By Robert M. Califf MD – Last month was the one-year anniversary of the White House Conference and National Strategy on Hunger, Nutrition and Health. The FDA continues to make great progress on our nutrition efforts, which can help to combat the epidemic of diet-related disease.
By Donna R. Rivera PharmD MS & Paul G. Kluetz MD – Expanding ways to generate evidence can lead to an array of benefits for medical product development, including more diverse patient representation and the potential to expedite the availability of safe and effective therapies.
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