The European Medicines Agency published its annual report, listing 81 medicines recommended for approval in 2016, including 27 new active substances. Source: Drug Industry Daily
Scheduling conflicts unrelated to the must-pass FDA user fee reauthorization bill postponed a planned markup Wednesday, but the Senate HELP committee has rescheduled the session for today. Source: Drug Industry…
PhRMA unveiled new criteria for membership, setting higher R&D requirements — and eliminating its associate member level entirely, which included 15 pharmaceutical companies. Source: Drug Industry Daily
Following the FDA’s addition of a Chinese API manufacturer to an import alert early last month, the World Health Organization was left without a prequalified source for the birth control…
The European Medicines Agency announced a new plan for closer collaboration between regulatory bodies and academia. Source: International Pharmaceutical Regulatory Monitor
The European Medicines Agency Committee for Medicinal Products for Human Use recommended 11 medicines for approval, including four orphan drugs and three biosimilars. Source: International Pharmaceutical Regulatory Monitor
The European Medicines Agency plans to clarify its role regarding drugs manufactured in the EU solely for the export market. Source: International Pharmaceutical Regulatory Monitor
The European Medicines Agency says clinical trial master files should also include quality reports and checklists, product certifications and trial-specific computer system guides — essential documents that are not listed…
<IMG SRC"http://enewsletters.biospace.com/images/news/biospace-news-815x450-stocks5.jpg" NAME"4 Biotechs That Could Release Stock-Shattering Data Soon" ALT"4 Biotechs That Could Release Stock-Shattering Data Soon"May 10, 2017By Mark Terry, BioSpace.com Breaking News StaffPolitical... Source: BioSpace