Warning Letter Roundup & Recap – October 2022
The US Food and Drug Administration published two warning letters last month, with one going to aesthetic device company Flawless Beauty and Skin and the other being sent to power chair manufacturer Forcemech International.
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The company believes the Phase III Clarity AD results offer a high level of evidence that may convince the Centers for Medicare and Medicaid Services to change its stance on anti-amyloid antibodies for lecanemab.
Substantially more consumers in 2022 report sleep issues, allergies and skin problems than in 2018 while using quit smoking aids has dropped, according to CHPA’s latest “Value of OTC Medicines” survey. Average annual household spending on OTCs is $645.
FDA “understands that manufacturers expect availability to continue to increase in the near future.” CHPA is working with members “focused on safeguarding the US supply by maximizing capacity to produce and direct product to where it is needed most.”