The Bipartisan Policy Center, with three former FDA commissioners on its leadership team, issues a report with 12 recommendations for expanding use of...
Medline Industries recalls its Medline Primary Warmer Pack because it contains the recalled Becton Dickinson Alaris Infusion Sets for the Alaris Pump ...
Edwards Lifesciences recalls its Sapien 3 Ultra Delivery System due to balloon bursts during surgery.
Federal Register notice correction: FDA corrects a 6/21 notice entitled Standards for Future Opioid Analgesic Approvals and Incentives for New Therape...
The environmental publication Down to Earth says Indian drug companies received 13 of the 38 Warning Letters FDA has issued so far this year.
CDRH releases its list of 10 current regulatory science priorities.
A Pew Charitable Trusts report says FDA should do more to deter businesses from selling stem cell interventions whose safety and effectiveness have no...
FDA accepts for priority review a BeiGene NDA for zanubrutinib for treating patients with mantle cell lymphoma who have received at least one prior th...