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The White House Office of Management and Budget’s decision to sequester nearly $85 million of FDA user fees is wrong, and should be reversed immediately, lawmakers say. Read More
The FDA’s proposed new labeling requirements for generics pose such a challenge to industry that GPhA has asked the FDA for an additional two months to comment on the proposed rule. Read More
The FDA has notified Biogen Idec that it needs more time to review its BLA for Alprolix after the drugmaker submitted additional data supporting the validation of a key manufacturing step. Read More
Baxter has issued another recall, this time for a single lot of the nitroglycerin 5 percent dextrose injection, a drug used for pre- and post-operative hypertension, congestive heart failure at the onset of heart attack and chest pain. Read More
The FDA has agreed to review Purdue Pharma's NDA for its investigational Targiniq ER controlled-release tablets CII for the management of chronic pain. Read More
The European Medicines Agency (EMA) has provided generic drugmakers its first roadmap to meeting standardized EU bioequivalence requirements. Read More
Shortly after Duchesnay received FDA approval for its morning sickness drug Diclegis, the agency says the Canadian drugmaker sent a letter to customers touting the drug’s benefits but none of its risks. Read More
The FDA is proposing to give generic drugmakers the power to revise product labeling in response to safety issues prior to agency approval — a power that brand drugmakers already have. Read More
Despite not agreeing on primary endpoints with the FDA before beginning clinical trials for a new sleep disorder drug, Vanda was able to get an almost unanimous recommendation from an advisory committee earlier this month. Read More