Generic drugs program has approved almost 300 manufacturing changes to help shore up the supply chain, with some prior approval supplements being downgraded to ‘changes being effected’ supplements, FDA officials said at GDUFA III kick-off meeting.

Dispatches from a world turned upside down also include the conditional approval of remdesivir in South Korea.

US FDA’s ‘may be effective’ standard for granting an emergency use authorization is expected to be comparable to the substantial evidence of effectiveness needed to support full licensure of a COVID-19 vaccine, although EUA allows for a more rapid review, agency officials say.

IPEC-Americas requests an improved communications channel with the FDA and formal inclusion in talks to reauthorize the generic drug user fee program; agency says industry negotiators generally represent product manufacturers and API suppliers that are subject to user fees.

Generic drugs program has approved almost 300 manufacturing changes to help shore up the supply chain, with some prior approval supplements being downgraded to ‘changes being effected’ supplements, FDA officials said at GDUFA III kick-off meeting.

IPEC-Americas requests an improved communications channel with the FDA and formal inclusion in talks to reauthorize the generic drug user fee program; agency says industry negotiators generally represent product manufacturers and API suppliers that are subject to user fees.