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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
The House Energy & Commerce Committee is calling on the GAO to evaluate whether the FDA’s regulatory pathway for generic versions of complex drugs is sufficient. Read More
In what may be a first, the FDA has settled an industry suit accusing the agency of overstepping its regulatory authority over pharmaceutical promotion. Read More
India’s Natco Pharma and partner Alvogen announced Monday that they have settled a patent infringement suit filed by Gilead Sciences, Roche and Genentech over a proposed generic version of Tamiflu. Read More
With the clock about to strike midnight on 2015, CDER Director Janet Woodcock laid out a set of priorities the center will focus on in 2016, with negotiating new PDUFA and GDUFA agreements topping that list. Read More