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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
Pharmaceutical companies can expect to wait about 165 days for Health Canada to make a final decision on appeals of an approval or rejection of a drug, according to guidance released earlier this month that sets specific timelines for every step of the dispute resolution process. Read More
Mylan has settled patent litigation related to Pfizer’s Viagra, paving the way for generic copies of the erectile dysfunction blockbuster in the U.S. in 19 months. Read More