Compounding: Groups Tell FDA To Drop “Traditional” and “Non-Traditional” Categories
Stakeholders say it would create more confusion in the pharmacy and regulatory community; they also spar over whether volume, other criteria should be imposed to distinguish compounding types.
You may also be interested in...
FDA officials state in journal article that manufacturers are not incentivized to ensure quality and base competition entirely on price.
The agency has the option to issue regulations requiring biologics manufacturers to notify FDA of emerging production problems, but so far it’s only “something that we’re thinking about.”
The agency is considering how to move forward as Pfizer studies a third shot after missing an efficacy endpoint in children age 2 to 5.