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With 12 nations signing off on the Trans-Pacific Partnership on Wednesday, the clock has started on ratification of the treaty providing up to eight years of exclusivity for biologics. Read More
The FDA is re-examining its approval, REMS and postmarket policies for opioids in response to a growing abuse epidemic and calls to action from lawmakers. Read More
House members are growing impatient with the FDA over a lack of guidance on biosimilars, with several venting their frustrations during a hearing Thursday. Read More
Democrats and Republicans of the House Oversight Committee took executives of Valeant Pharmaceuticals and Turing Pharmaceuticals to task on Thursday over what members called a strategy of buying old drugs with no generic competition and “jacking up” the prices for profits. Read More
The FDA’s Psychopharmacologic Drugs Advisory Committee will convene March 29 to review Acadia Pharmaceuticals’ Nuplazid for the treatment of psychosis associated with Parkinson’s disease. Read More
CBER is asking biologics manufacturers to allow the center’s regulatory review, compliance and other relevant staff to visit facilities to help them better understand the biologics industry. Read More
Federal efforts to protect the drug supply chain continue to bear fruit, with the FDA’s Office of Criminal Investigations announcing criminal charges for another counterfeit operation. Read More
Several major drugmakers are exploring development of a vaccine to prevent the Zika virus as the mosquito-borne disease spreads quickly throughout the Western Hemisphere. Read More