Topic: FDA warning letter
The FDA has nailed an Australian contract manufacturer with a warning letter for serious manufacturing and quality lapses.
From the FDA’s point of view, OTC drugs and weedkiller just don’t mix. That is the message delivered in a newly posted warning letter to an Iowa company.
Five months after blocking the products of Prosana Distribuciones from the U.S., the FDA has issued a warning letter for the Mexican company.
A Fresenius Kabi cancer drug plant savaged by the FDA in the past for hiding serious drug testing issues has been slapped with a new warning letter.
BMS forms new I-O deal with Ono, Eisai's Lenvima wins NICE nod in kidney cancer, Sanofi tries to dig out of Philippines Dengvaxia fallout.
A Korean drug company has received a warning letter after FDA inspectors determined it had no quality checks and was handling manufacturing by phone.
Takeda offloaded cancer assets, AstraZeneca formed drug discovery JV in China, Biocon's Herceptin biosimilar plant cleared FDA.
It turns out pharma's ad police aren't done doling out warnings in a year that's seen a historic few.
Pfizer exits a JV with China's Hisun Pharma, FDA approved the first digital medicine, and Astellas was added to a charity donation probe.
Lupin has been trying for two years to bring its plant in Goa, India, up to FDA standards, but a new warning letter says more improvements are needed.