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- FDA warns Chinese API manufacturers for refusing records requests, quality oversightThe US Food and Drug Administration (FDA) recently issued warning letters to three manufacturers of active pharmaceutical ingredients (APIs) based in China. Two of the companies were warned for ref…raps · 1d ago↗ source
- This Week: Senate HELP to vote on Overton, FDA shelves CNPV, and moreWelcome 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 wee…raps · 1d ago↗ source
- Eli Lilly’s Mounjaro and Merck’s oral PCSK9 inhibitor win FDA nod amid string of cardiovascular trial setbacksThe cardiovascular drug development landscape entered the American Heart Association’s Scientific Sessions with a mix of optimism and disappointment. Recent months have seen several late‑stage tria…