FDA warns Genesis Ultra Slim that its Ultra Slim Gold is a misbranded unapproved new weight loss drug.
FDA approves Impel NeuroPharmas Trudhesa migraine nasal spray treatment.
FDA approves a TransMedics Group PMA for its OCS Heart System for use with organs from donors after brain death.
Federal Register notice: FDA corrects an 8/10 notice announcing a 9/17 Pediatric Advisory Committee meeting.
Federal Register notice: FDA seeks comments on an information collection extension entitled Reclassification Petitions for Medical Devices.
Federal Register notice: FDA seeks comments on an information collection revision entitled Labeling Requirements for Prescription Drugs.
Federal Register notice: FDA announces a 9/17 Vaccines and Related Biological Products Advisory Committee meeting to discuss a Pfizer-BioNTech supplem...
CDER starts its Novel Excipient Review Pilot Program to foster the development of excipients for when excipient manufacturers and drug developers have...