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CDRH is pleased to announce that we have been operating under normal review timelines for all incoming premarket submissions for almost a year, and we’re accepting all submission types for review.
Duodeonoscopes, the technology at the heart of several superbug outbreaks, have been a problem for decades, the FDA issue guidance cleaning only Thursday.
Top House lawmakers wrote to the director of the FDA Center for Biologics Evaluation and Review, asking why the agency so frequently issues clinical trial holds to experimental cell and gene therapies.
The two federal programs intended to compensate people injured by vaccines or pandemic countermeasures are fielding thousands of claims unlikely to be resolved — or paid out — anytime soon.
The announcement from the Food and Drug Administration follows years of pressure from disability rights groups and mental health experts who have called the treatment outdated, ineffective and unethical.