USA – FDA authorizes Pfizer and Moderna’s bivalent COVID vaccines
The US Food and Drug Administration (FDA) on Wednesday authorized bivalent COVID-19 vaccines targeting the Omicron BA.4/5 subvariants developed by Pfizer-BioNTech and Moderna, asserting...
USA – Generic manufacturers call for changes to list of major deficiencies
Generic drug manufacturers are urging the US Food and Drug Administration (FDA) to revise its guidance on amendments to Abbreviated New Drug Applications (ANDA)...
USA – NIH aims to reduce reputation bias in grant reviews
The US National Institutes of Health (NIH) has released a tentative plan to change how its research grant applications are scored, with the aim of reducing...
USA – Guidance: FDA details ANDA PSG meetings under GDUFA III
The US Food and Drug Administration (FDA) last week issued draft guidance that details its thinking on conducting product-specific guidance (PSG) meetings with generic...
USA – FDA amends COVID vaccine EUAs, considers animal studies to accelerate updates
Monovalent messenger ribonucleic acid (mRNA) COVID vaccines from Moderna and Pfizer/BioNTech are no longer authorized for use in the US, the US Food and...
USA – FDA proposes updated medtech RWE guidance
The US Food and Drug Administration (FDA) has updated it’s guidance on how real-world data (RWD) can be used to provide real-world evidence (RWE)...
USA – Combination products: FDA finalizes list of CGMP alternatives, streamlined mechanisms
The US Food and Drug Administration (FDA) has released a finalized list of alternatives and streamlined mechanisms for current good manufacturing practice (CGMP) of...
USA – Biosimilar facilities usually get onsite inspections
A US Food and Drug Administration (FDA) official said that sites making biosimilars will be inspected in person, as opposed to virtual methods, as...
USA – FDA revises guidance on delaying, denying, limiting or refusing an inspection
On Dec. 15, 2022, the FDA released for public comment Circumstances that Constitute Delaying, Denying, Limiting, or Refusing a Drug or Device Inspection Revision 1....
USA – Advanced manufacturing: GAO, USP reports say regulatory enhancements needed
The Government Accountability Office (GAO) and the United States Pharmacopeia (USP) asserted in two recent reports that the regulators need to address some of...
