FDA tells Passage Bio that a randomized controlled trial will be required to support approval of its experimental gene therapy for a rare form of deme...
FDA clears a Philips 510(k) for its new Spectral CT Verida system, which the company describes as the first AI-powered detector-based spectral CT scan...
FDA posts a draft guidance outlining how drugmakers should establish impurity specifications for antibiotics produced by fermentation and semi-synthet...
FDA issues a draft guidance outlining a proposed compliance policy that could ease certain premarket requirements for respirators already approved by ...
FDA has granted Opna Bio a fast track designation for its investigational therapy OPN-6602 and its use in treating patients with relapsed or refractor...
U.S. Sen. Susan Collins (R-ME) uses a Senate hearing 4/16 to spotlight barriers to lower-cost drugs, pressing an expert witness on delays in bringing ...
An Institute for Clinical and Economic Review white paper states the potential benefits and challenges of several policy changes that could strengthen...
AdvaMed says it supports FDA efforts to expand exemptions from premarket notification for some Class 2 devices.
