Federal Register notice: FDA makes available a final guidance entitled Control of Nitrosamine Impurities in Human Drugs.
FDA reminds healthcare providers of the advisability of conducting a trial stimulation period in patients before implanting a spinal cord stimulator.
Amylyx Pharmaceuticals announces promising clinical trial results for amyotrophic lateral sclerosis investigational drug AMX0035.
A detailed Washington Post story explores the pressures on FDA to authorize or approve a Covid-19 vaccine within the next few weeks.
CDER says its more extensive testing found NDMA in only eight of 16 metformin samples in which it was found by a private laboratory.
FDA clears a SoftWave Tissue Regeneration Technologies 510(k) for using its SoftWave technology for treating superficial, partial-thickness, second-de...
FDA issues a revised and updated draft guidance on pharmacokinetic study design and analysis for patients with impaired renal function.
Sen. Ted Cruz and 19 other senators call on FDA to order the abortion drug Mifeprex off the U.S. market.