Federal Register notice: FDA announces an 11/9 device panel meeting that will review a Refocus Group PMA for the VisAbility Micro Insert, an implant f...
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FDA issues a revised and updated draft guidance on pharmacokinetic study design and analysis for patients with impaired renal function.