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FDA releases the form FDA-483 with two observations from an inspection at Branchburg, NJ-based ImClone Systems.[ Price : $8.95]
Former CDRH cybersecurity acting director Kevin Fu says the best companies are already submitting software bills of materials with...[ Price : $8.95]
A recent inspection at Hikma Injectables USA results in a three-item Form FDA-483.[ Price : $8.95]
FDA publishes a draft guidance on proposed updates to an earlier breakthrough devices program guidance.[ Price : $8.95]
FDA closes its post-approval study requirements for Abiomed PMAs for its Impella heart pumps after reviewing favorable performance...[ Price : $8.95]
FDA launches its Advancing Real-World Evidence Program intended to improve the quality and acceptability of real-world evidence ap...[ Price : $8.95]
Federal Register notice: FDA announces that it is continuing a meeting program to advance the use of complex adaptive, Bayesian, a...[ Price : $8.95]
PTC Therapeutics says enrollment in its Phase 2 Huntingdons disease trial has been paused in the U.S. due to an FDA request for ad...