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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FDA has okayed the use of a single trial to prove efficacy of any drug developed to treat Fabry Disease, according to a draft guidance the agency issued last week.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
The FDA should look into inconsistencies in its written comments to generic drug applicants to improve approval rates, the Government Accountability Office (GAO) says in a report released Wednesday. Read More
The FDA’s Antimicrobial Drugs Advisory Committee voted Wednesday to recommend Gilead Sciences’ supplemental NDA for Descovy (emtricitabine and tenofovir alafenamide ) for prevention of HIV-1 infections in men and transgender women — but shot down the drug for use in cisgender women. Read More
The International Coalition of Medicines Regulatory Authorities (ICMRA) urged regulatory agencies around the globe to step up their efforts to fight antimicrobial resistance (AMR). Read More