CDER’s Office of Prescription Drug Promotion (OPDP)’s four-person research team investigates issues in direct-to-consumer and health care provider-directed prescription drug promotional communications. The team uses methodologies such as surveys, experimental...

Disclaimer: Early release articles are not considered as final versions. Any changes will be reflected in the online version in the month the article is officially released. Author affiliation: Vanderbilt University Medical Center, Nashville, Tennessee, USA (P.W....

AUDIENCE: Patient, Health Care Professional, Pharmacy, Cardiology, Neurology, Internal Medicine, Family Practice, Travel ClinicsUPDATE: On August 22, 2025, the US FDA’s Center for Biologics Evaluation and Research (CBER) has suspended the biologics license for Valneva...

HOW TO USE THIS SNAPSHOTThe information provided in Snapshots highlights who participated in the key clinical trials that supported the original FDA approval of this drug, and whether there were differences among sex, race, age, and ethnic groups. The “MORE INFO” bar...

510(k) Number: BK251199 Applicant: EUROMI S.A Device Name: NLF system® kit 2 (EUROMI)Decision Date: 8/14/2025Supporting Documents Content current as of: 08/15/2025...