FDA clears a Pearl 510(k) for its Second Opinion, an artificial intelligence radiologic detection aid intended to help dentists identify numerous comm...
CDER posts its FY 2021 GDUFA Science and Research Report that updates stakeholders on the development of innovative methodologies and more efficient t...
FDA asks stakeholders to comment on proposed changes to the drug quality metrics reporting program that has been tested in two pilots.
FDA says the computer software company PTC is recommending actions to be taken by medical device manufacturers who use PTCs Axeda agent or desktop ser...
An Illinois federal court approves a permanent injunction against Waukegan, IL-based dietary supplement maker Salud Natural Entrepreneur.
Mallinckrodt agrees to pay $260 million to resolve allegations that it violated the False Claims Act by knowingly underpaying Medicaid rebates due for...
FDA denies a petition seeking a stronger Warning on labeling of OTC drugs with anticholinergic effects.
Three more drug companies comment on an FDA draft guidance on using real-world evidence and data in regulatory decision-making for drugs and biologics...