Gounder notes the policy requires no testing of finished vials or deadline for side effect reports, and public comments on the draft run through November 13.
Recap by typeshit. Full story at https://www.celinegounder.com/.
Per @pamelajeannoble, the letter flags contamination risks, manufacturing conditions and compounded copies resembling approved drugs.
Healio
Durrani tells Healio the move bypassed rulemaking and FDA scientists, and warns patients may wrongly read it as FDA approval while long-term data is missing.
AP sources say FDA scientists opposed the HHS draft telling the agency not to act against pharmacies compounding six wellness peptides. Comments are open for two weeks.
Law firm Frier Levitt reads the rule as single-ingredient only, so the popular blend stays out. Public Citizen and ex-FDA official Janet Woodcock voice safety concerns.
AllSci looks at how Eli Lilly's third quarter shaped up, with retatrutide adding weight to its GLP-1 lineup and more cancer drugs moving through development.
West Pharmaceutical shares are up about 20% since CNBC flagged the valuation in August, and the latest earnings give it reasons to expect further gains.
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