HHS secretary Robert F. Kennedy Jr. curtails his public commentary on vaccines as part of a deliberate political strategy by the Trump administration for its midterm election campaign.
Minutes of the 3/10 and 3/12 PDUFA 8 reauthorization steering committee sessions, progress was reported on the America First fee incentive discussion, and a fee proposal for non-orphan indication supplements.
HHS secretary Robert F. Kennedy Jr. curtails his public commentary on vaccines as part of a deliberate political strategy by the Trump administration for its midterm election campaign.
Minutes of the 3/10 and 3/12 PDUFA 8 reauthorization steering committee sessions, progress was reported on the America First fee incentive discussion, and a fee proposal for non-orphan indication supplements.
The CDER Office of Prescription Drug Promotion says an Amneal patient brochure for its Avastin biosimilar Alymsys is false or misleading in several ways.
Vanda Pharmaceuticals says FDA should withdraw a legislative proposal in its budget package that the company says would lengthen NDA review times and hurt the legal appeal process available to companies aggrieved by an FDA decision.
