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In its latest biennial report to Congress on high-risk government programs, the GAO downgraded its rating of the FDA’s action plans, saying CDER, CBER and CDRH’s long-term strategies lack adequate details and performance measures. Read More
The EMA completed all inspections and scientific advice procedures on time and met its performance targets in the first half of 2016 even as GMP inspection requests and orphan designation applications rose, according to a newly released report. Read More
Novartis and the Association for Accessible Medicines, formerly known as GPhA, are criticizing the FDA for underestimating the effect that using random suffixes to identify biologics and biosimilars will have on drugmakers, the market and pharmacovigilance. Read More
PhRMA called on the U.S. trade representative to assess threats and barriers to intellectual property in 18 countries, and to focus in particular on China, India, Colombia, and Canada. Read More
Three senators urged newly confirmed secretary of HHS, Tom Price, to fast track the importation of certain prescription drugs from Canada following “significant or unexplained” increases in U.S. prices. Read More