Topic: FDA warning letter
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.
Pharma can usually look back at FDA enforcement letters for insight into the agency's thinking on marketing communications. Not this year.
Teva is reportedly looking to form a Chinese JV, Lupin was hit with an FDA warning letter, EOC Pharma raised $32 million in series B and more.
The FDA has slapped a warning letter on a Chinese company that shipped multiple lots of an OTC product to the U.S. that contained the wrong API.
India’s Lupin has received a warning letter for two of its plants in India, one which it is key to launching new drugs in the U.S.
The FDA has banned the OTC products of a Canadian drugmaker after finding it was using ingredients from a supplier already on its import alert list.