Label Change Proposal From GPhA, PhRMA Makes FDA Responsible For Timing

“Expedited Agency Review” idea would require an FDA review of proposed safety-related labeling changes before they are made and end the CBE-0 system brand companies already use and generics could be required to adopt.

Generic and brand drug industry groups now agree that the burden for requiring a safety-related labeling change should rest entirely with FDA, even if the process is initiated by sponsors.

In a rare collaboration, the Generic Pharmaceutical Association and Pharmaceutical Research and Manufacturers of America created an alternative proposal to...

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