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A sweeping deal to keep the government running through next fall is expected to come to a vote Friday, under which the FDA would be awarded $4.68 billion in total funding for fiscal year 2016. Read More
The FDA is recommending that drugmakers create safety assessment committees and formalized surveillance plans to watch for serious adverse events in clinical trials to decide when safety data should be unblinded. Read More
Eli Lilly scored a win at the FDA Wednesday, with the agency approving the company’s insulin glargine injection, Basaglar, to improve glycemic control in patients with Type 1 and 2 diabetes. Read More
Citing significant price increases for certain generic drugs, House Republicans have sent a letter to Acting FDA Commissioner Stephen Ostroff with concerns about the agency’s process for approving ANDAs. Read More
Valeant Pharmaceuticals faced renewed scrutiny Wednesday on two fronts, with a lawmaker accusing the company of obstructing a congressional investigation and investors questioning the company’s long-term viability in the face of a dismal earnings report. Read More
During a one-year period, the UK’s Medicines & Healthcare products Regulatory Agency conducted 47 inspections of pharma companies, during which they found 27 critical findings, 169 major and 155 minor findings. Read More
Legal experts say the FDA’s off-label regulation of pharmaceuticals may be on shaky ground after it agreed to settle with Pacira Pharmaceuticals this week in a case involving the pain drug Exparel. Read More