资讯

100 days into the job, FDA head talks to CNN about agency goals— and Coke’s switch to sugar
Marty Makary says the FDA will plow ahead with big plans on ultra processed foods, dietary guidelines, and expedited drug and ...
PharmExec10 小时
Replimune CRL Fallout: How Biopharma Leaders Should Manage a New Layer of FDA Uncertainty
A deep dive into the implications of the Replimune CRL that surprised insiders and investors, the role of new leadership at ...
FDA names former pharmaceutical company executive to oversee US drug program
FDA Commissioner Marty Makary announced that Dr. George Tidmarsh, a cancer and pediatric specialist, will direct the agency’s ...
BioSpace2 天
From Expertise to Empty Chairs: The FDA’s Self-Inflicted Crisis
While FDA Commissioner Marty Makary emphasizes learning and humility, the FDA has systematically removed the very experience ...
BioSpace2 天
FDA Opens Pilot Run of Commissioner Voucher Program
The FDA will select at most five companies that align with national priorities, including lower drug prices and increased ...
FDA Commissioner: 100 Days of Change—Modernizing the FDA for a Healthier America | Opinion
The Food and Drug Administration (FDA) can maintain its high bar for safety and efficacy, and also cut the waste and ...
Fierce Pharma4 天
FDA names next CDER director in biotech vet George Tidmarsh
FDA Commissioner Marty Makary, M.D., has made his pick for the next director of the FDA’s Center for Drug Evaluation and ...
Fierce Pharma11 天
Ultragenyx takes another hit as FDA snubs AAV gene therapy over manufacturing issues
The manufacturing-related rejection for UX111 is more than a setback for Ultragenyx, as it also delays a key test of the new ...
JD Supra1月
Staying Prepared Amid FDA Changes | Gardner Law - JDSupra
Despite recent staffing reductions and leadership transitions at the FDA, pharmaceutical and medical device manufacturers should not interpret these changes as a signal of reduced regulatory ...
PBS1月
FDA commissioner defends changes to COVID vaccine recommendations
Amna Nawaz: In a significant shift this week, Health Secretary Robert F. Kennedy, Jr., joined by FDA Commissioner Dr. Martin Makary and NIH Director Dr. Jay Bhattacharya, announced that COVID-19 ...
USA Today2月
What to know about the FDA's latest COVID-19 vaccine changes - USA TODAY
COVID-19 vaccine recommendations could be changing, according to the U.S. Food and Drug Administration. FDA leaders said on May 20 that clinical trials will be required to approve annual COVID-19 ...