The Alliance for Regenerative Medicine raises concerns about an FDA draft guidance on alternative manufacturing technologies.
FDA approves Bristol Myers Squibbs Opdivo (nivolumab) for combination use with cisplatin and gemcitabine for first-line treatment of adult patients wi...
Five House Republicans and one Democrat from Arizona and California call on FDA to add Valley Fever to the list of tropical diseases eligible for the ...
FDA classifies as Class 1 a Medtronic Neurology recall of its Duet External Drainage and Monitoring System due to the potential for catheter disconnec...
Federal Register notice: FDA makes available two International Council for Harmonization final guidances entitled Q2(R2) Validation of Analytical Proc...
Federal Register notice: FDA renews its Gastrointestinal Drugs Advisory Committee for an additional two years beyond the charter expiration date.
Ventec Life Systems recalls its VOCSN Patient Breathing Package due to a manufacturing issue that causes the bonded spiral wrap to detach before or du...
FDA publishes the ICH Q14 guidance on analytical procedure development.
