Compounding Warning Letter Format Unchanged Since Legislation
This article was originally published in The Pink Sheet Daily
FDA’s first two warning letters since draft compounding guidances may be another way to encourage outsourcer registration.
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Agency releases 483 forms from a post-crises inspection push; the effort may help FDA illustrate its inspection capabilities to Congress and states and indicate the agency’s oversight plans under the new authority it has proposed.
State regulators seem to agree with FDA about confusion over regulatory responsibility, saying writing consistent definitions for compounding and manufacturing will help determine future FDA involvement.
US FDA’s Search For Class-Wide Vaccine Blood-Clot Effect Makes Scientific Sense, But Raises Questions
Several adenovirus vaccine developers say the products cannot be compared, potentially complicating the US FDA and CDC’s decision on ending the recommended pause in the use of Janssen’s vaccine.