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The new rule establishing FDA powers to destroy suspected counterfeit and adulterated drugs could cause shortages if the agency doesn’t protect against officials destroying needed excipients that get caught up in an import dispute, according to PhRMA. Read More
Pfizer is facing at least three class action lawsuits alleging that the company went to extraordinary, fraudulent lengths to maintain exclusivity over its multibillion dollar arthritis pain drug Celebrex and keep generic competitors off the market. Read More
Some melanoma patients in the EU will now have access to GlaxoSmithKline’s Mekinist, following the European Commission’s approval of the drug as a single agent for patients with unresectable or metastatic disease fueled by a BRAF V600 mutation. Read More
Clinical research firm Clinipace Worldwide wants the FDA to sign off on a generic version of Merck’s osteoporosis drug Fosamax by declaring that three strengths of the drug were not discontinued for safety or effectiveness reasons. Read More
The FDA and Customs and Border Protection last month began accepting applications for an 18-month pilot of a “trusted trader” program to reduce inspections and oversight of imports from drugmakers that establish tough internal import control programs of their own. Read More
With a deadline looming, the pharmaceutical industry still needs to decide which data systems are most efficient and cost-effective for implementing the federal track-and-trace law, experts say. Read More