Agency continues to analyze facility data following generic drug facility fee announcement; some fees were higher than anticipated after fewer manufacturing plants registered than expected. But industry believes the count is accurate and illustrates the influence of foreign manufacturers.
After completing its first generic drug user fee self-identification process, FDA may still be wondering whether it met its goal of gaining a better handle on the extent of the manufacturing landscape.
The new information will serve as the baseline for future efforts to track and oversee manufacturing of the U.S. generic...
HHS Secretary Kennedy's new ACIP appointments include multiple members of anti-vaccine groups and people who have spread misinformation about COVID-19 vaccines.
Commissioner Martin Makary told staff that plans are being developed to centralize HR, IT, travel and other functions, which were heavily impacted by the 1 April reduction-in-force.
The House Appropriations Committee wants an analysis of how issues that led to CRLs could have been resolved within the first review cycle and seeks an agency crackdown on counterfeit GLP-1 agonists.
While the adoption of most favored nation drug pricing in the US stands to affect Japanese biopharma firms now heavily reliant on this market, it might also present an opportunity for pricing and policy reforms at home.
Merck’s newly approved Enflonsia for RSV is one of the products expected to be recommended for use by the CDC Advisory Committee on Immunization Practices later this month.
Cindy Eckert’s social media post with a People.com story failed to include any risk information, made misleading representations about benefits and omitted material information about the indication, said the agency, which flagged similar concerns about an Addyi radio ad five years ago.
Robert Foster, HHS deputy general counsel and chief counsel for food, research and drugs, is temporarily heading the Office of Chief Counsel, but a permanent appointee is expected after Michael Stuart's confirmation as HHS general counsel.
