Talaris says it has informed FDA about the death of a subject in the FREEDOM-1 trial of FCR001 in live donor kidney transplant recipients.
FDA releases the form FDA-483 with two observations from an inspection at Branchburg, NJ-based ImClone Systems.
Former CDRH cybersecurity acting director Kevin Fu says the best companies are already submitting software bills of materials with their 510(k) and PM...
A recent inspection at Hikma Injectables USA results in a three-item Form FDA-483.
FDA publishes a draft guidance on proposed updates to an earlier breakthrough devices program guidance.
FDA closes its post-approval study requirements for Abiomed PMAs for its Impella heart pumps after reviewing favorable performance data.
PhRMA raises issues about the CDER Quality Management Maturity and Knowledge-Aided Assessment and Structured Application programs to be considered by ...
FDA launches its Advancing Real-World Evidence Program intended to improve the quality and acceptability of real-world evidence approaches proposed by...
