Lowering the highest approved OTC acetaminophen dose would result in pain relief that is "inadequate or of limited duration for many individuals," McNeil Consumer & Specialty Pharmaceuticals tells FDA's Nonprescription Drugs Advisory Committee
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Although the UK Health Research Authority’s initial proposal for simplified informed consent was rejected by stakeholders, it has yielded valuable insights into reducing trial burden and widening access
Ultragenyx said talks with the FDA about a path forward after receiving a CRL for UX111 have been productive despite the recent upheaval at the agency.
Many agency stakeholders believe Vinay Prasad may be forced to change his regulatory approach at least somewhat after receiving a second chance to lead the US FDA's biologics center.
