Labeling Updates For Old Drugs Could Be Faster Under Streamlining Proposal
Stakeholder group's proposed pilot program to correct outdated drug labeling calls for US FDA to identify older products needing updates and contract out for evidence reviews, but agency and generic drug industry raise concerns about complexity, resources and product liability.
You may also be interested in...
Agency is launching an initiative to encourage manufacturers exempt from the final rule to implement the labeling format change anyway; the rule does not apply to drugs approved before June 30, 2001, and only about 10% of brand products have the new format.
Despite lack of enthusiasm with immunobridging study data, the panel endorsed emergency use in certain at-risk populations, in part because it would be hard to turn down the Moderna booster when an identical EUA had been issued for Pfizer/BioNTech's mRNA vaccine.
Immune responses to a single booster dose of mRNA-1273 would be considered successfully bridged to the two-dose primary series if each of two immunobridging criteria were met, but the mRNA vaccine missed the prespecified success criteria for seroresponse rate, the FDA said.