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 generics and biosimilars to market.
FDA posts a draft guidance outlining how drugmakers should establish impurity specifications for antibiotics produced by fermentation and semi-synthetic processes.
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 generics and biosimilars to market.
FDA posts a draft guidance outlining how drugmakers should establish impurity specifications for antibiotics produced by fermentation and semi-synthetic processes.
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 scanner.
FDA issues a draft guidance outlining a proposed compliance policy that could ease certain premarket requirements for respirators already approved by National Institute for Occupational Safety and Health, signaling a shift toward reduced regulatory burden for widely used protective devices.
