Extreme Makeover: ANDA Edition – FDA Asks Industry What It Wants Changed
This article was originally published in The Pink Sheet Daily
To meet GDUFA review goals, agency wants to know how it can help generic sponsors prepare better ANDAs and avoid common deficiencies.
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After appealing FDA’s rejection, Charleston narrowly tailored the proposed indication for its emesis-reducing opioid to an in-patient population and crafted its own REMS to try and address advisors past safety concerns. Briefing documents indicate the FDA might have been learning towards approving the drug on the earlier review cycle, but the initial advisory committee vote shifted the agency’s thinking.
COVID-19 Vaccines: FDA’s Broad Authority To Craft Narrow EUAs May Push Agency Out Of Its Comfort Zone
US FDA may not be comfortable using some of the powers the emergency use authorization statute provides to limit a product’s use; regulatory distinctions for EUAs go beyond the lower ‘may be effective‘ standard needed for an authorization versus an approval. EUAs come with a lot of other tools to micromanage use that aren’t available for most approvals.
FDA indicates it expects sponsors and other government agencies to come up with ways to fulfill its request for placebo-controlled studies post-emergency use authorization of COVID-19 vaccines, but neither it nor vaccines advisory committee see a clear way to do this.