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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
The FDA hailed a D.C. court’s decision to uphold the agency’s method for assessing if there’s a clinical need for a bulk drug substance as a “victory for public health” and reiterated its focus on oversight of compounders. Read More
Drugmakers, trade groups and medical professionals have reservations about the FDA’s proposed blister pack requirements for certain immediate-release opioids, public comments show. Read More
The FDA is investigating a Novartis subsidiary over “data manipulation” reported only after the agency approved its gene therapy Zolgensma (onasemnogene abeparvovec-xioi). Read More
The Federal Trade Commission has intervened in a proposed $625 million merger between two leading hydrogen peroxide manufacturers, citing concerns about the deal’s impact on the price of the compound used as an OTC antiseptic and for other purposes. Read More