This Week at FDA: Amazon warning letter, ANDA amendments, and more

This Week at FDA: Amazon warning letter, ANDA amendments, and more

Source: 
RAPS.org
snippet: 

Welcome to another installment of This Week at FDA, your weekly source for updates – big and small – on FDA, drug and medical device regulation, and what we’re reading from around the web. This week, we take a look at warning letters sent to online retail giant Amazon and two other companies for selling unapproved drugs for mole and skin tag removal. Plus, FDA has opened a public docket to gather feedback on its abbreviated new drug application (ANDA) amendments guidance, and we learned that Bavarian Nordic has some “reservations” about the Biden administration’s dose-sparing plan to stretch out the available doses of its monkeypox vaccine Jynneos.