FDA Related News

Biologics

Regeneron Interrupts Covid-19 Trial Enrollment

Regeneron Pharmaceuticals says it will temporarily stop enrolling patients requiring high-flow oxygen or mechanical ventilation in REGN-COV2 antibody ...

Human Drugs

Guide on Drug Standardized Study Date eSubmissions

FDA posts a revised guidance on Providing Regulatory Submissions in Electronic Format Standardized Study Data.

Human Drugs

Gene Therapy, Digital Health Boost in PDUFA Talks

FDA user fee reauthorization meetings look to advance efforts associated with its Cell and Gene Therapy Program and Digital Health Program.

Marketing

OPDP Director Tom Abrams Retires

CDER Office of Prescription Drug Promotion director Tom Abrams retires after 27 years at FDA.

Medical Devices

Medtronic Pays $8.1 Million to Settle Kickback Charges

Medtronic agrees to pay $8.1 million to resolve allegations that it violated the False Claims Act by paying kickbacks to a physician.

Human Drugs

Tricida Surprised at FDA Veverimer Comments

Tricida says it is surprised that FDA does not believe its veverimer development program provides sufficient evidence for accelerated approval.

FDA Using Emulate to Evaluate Covid Vaccine Safety

FDA continues a research agreement with Emulate to use its organ-chips in studies of Covid-19 vaccines.

Medical Devices

Medical Device Nitinol Increases Bench Testing: Analysis

Attorney Michael Kasser says requirements in a new FDA guidance could mean that medical device companies should avoid using nitinol unless its propert...

Human Drugs

Better Understanding of Heterogeneous Treatment Effects

Panelists from FDA, universities, and private companies look at ways to better understand the heterogeneous treatment effects of drugs.

Federal Register

Biosimilar User Fee Reauthorization Meeting

Federal Register notice: FDA announces an 11/19 virtual public meeting on reauthorizing the Biosimilar User Fee Act program.