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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
The Medicines Company’s Kengreal may be on the road to approval, with FDA reviewers backing its use as a post-angioplasty anticlotting agent one year after the agency rejected the drug for this and another indication. Read More
Pharma companies can expect to wait about 165 days for Health Canada to make a final decision on appeals of drug’s approval or rejection, according to April 1 guidance that sets specific timelines for every step of the dispute resolution process. Read More
Australian drugmakers want the government to create fast-track approval pathways for new cancer drugs, as well as parallel review processes that simultaneously assess safety and efficacy and reimbursement eligibility for new drugs. Read More