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The European Medicines Agency revised its 2009 advice to sponsors seeking evaluations of products intended exclusively for markets outside the EU. Read More
The European Medicines Agency is implementing a new form to submit required postmarket data on safety, efficacy and quality, and it is now a mandatory part of Module 1.0 of the electronic common technical document format. Read More
The FDA outlined its procedures for conducting filing reviews of ANDA applications, detailing the standards agency staff will use to judge whether a submission is sufficiently complete before beginning a formal evaluation. Read More
The FDA took its first step in requiring sponsors to submit REMS documents electronically, publishing a draft guidance that outlines the specifications. Read More
The European Medicines Agency updated its advice on navigating its centralized pre-authorization procedures to include a section on combination packs of medications. Read More
The FDA opened the doors to a dramatic new method for treating cancer — the genetic modification of a patient’s immune cells to fight the disease — by granting approval to Novartis’ Kymriah. Read More
The FDA approved Adamas Pharmaceuticals’ Gocovri (amantadine) for the treatment of dyskinesia in Parkinson’s disease patients receiving levodopa therapy, making it the first drug to be approved for that condition. Read More