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The agency will not award any vouchers after Sept. 30, 2020, unless the application is for a drug that was designated as a drug for a rare pediatric disease. Read More
The FDA has okayed the use of a single trial to prove efficacy of any drug developed to treat Fabry Disease, according to a draft guidance the agency issued last week. Read More
The UK has come up with a plan for authorizing imports of pharmaceutical products in case it leaves the EU on October 31 without a Brexit deal in place. Read More
Drug and biologic sponsors are generally complying with requirements or agreed commitments for postmarketing clinical trials, according to the latest report from the FDA. Read More