The Alpha Bioscience Labs owner says US-made, tested peptides can replace gray market supply. FDA staff had advised against adding the six to the bulks list.
Recap by typeshit. Full story at Yahoo.
Per @pamelajeannoble, the letter flags contamination risks, manufacturing conditions and compounded copies resembling approved drugs.
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.
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.
17:15
Sandy Gibson shares a personal update two months into taking tirzepatide and weighs whether it is doing its job.
The multi-year trial, Oura's first, will test whether ring data on sleep, heart rate and activity lines up with weight loss, HbA1c and staying on treatment.
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