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In response to overwhelming requests from industry, the FDA is extending to June 8 the comment period on its draft rule overhauling the ANDA and 505(b)(2) approval processes. Read More
Boehringer Ingelheim should see an FDA decision on its idarucizumab blood-thinning antidote by October, following receipt of priority review late this week. Read More
The FDA plans to discontinue accepting paper submissions from drugmakers submitting promotional materials for prescription drugs and offers guidance on how to submit such information using the electronic common technical document. Read More
Biosimilars manufacturers are looking to the FDA for official guidance on several aspects of regulation, including naming and interchangeability. Read More
The FDA is seeking specific suggestions on potential changes to the Generic Drug User Fee Act Performance Goals and Procedures, ahead of negotiations to reauthorize the law, which expires Sept. 30, 2017. Read More
Drugmakers can reduce the time it takes to obtain marketing authorization from EU regulators by about two months if they seek scientific advice and make suggested changes to their clinical development plans, a new analysis shows. Read More