FDA Related News

Human Drugs

FDA Proposes to Move to 12-digit National Drug Codes

Faced with running out of 10-digit codes, FDA proposes to move to a 12-digit format for national drug codes.

6 Ways to Improve Trial Diversity

Three Syneos Health executives give FDA six ways to strengthen its guidances on clinical trial diversity.

Biologics

Regulatory Review Didnt Slow Covid Vaccines: Marks

CBER director Peter Marks urges a move to continuous manufacturing for vaccines to gain from lessons learned during Covid-19 vaccine development.

Human Drugs

2 Trial Coordinators Say They Falsified Data

Two Tellus Clinical Research study coordinators in Florida plead guilty to falsifying clinical trial data.

Medical Devices

BioCircuit Technologies 510(k) for Nerve Tape

FDA clears a BioCircuit Technologies 510(k) for its nerve repair device, Nerve Tape, a sutureless option for surgical repair of transected nerves.

Federal Register

Draft Guide on Dose Banding in Labeling

Federal Register notice: FDA makes available a draft guidance entitled Human Prescription Drug and Biological Products Labeling for Dosing Based on W...

Federal Register

Orange Book Therapeutic Equivalence Guide

Federal Register notice: FDA has made available a draft guidance entitled Evaluation of Therapeutic Equivalence that explains how it evaluates generic...

Medical Devices

New Renuvion/J-Plasma Handpiece Available: FDA

FDA says it has cleared the Renuvion APR Handpiece for specific subcutaneous dermatological and esthetic procedures.

Human Drugs

Whitmer Wants Mifepristone REMS Lifted

Michigan Gov. Gretchen Whitmer urges FDA to eliminate all REMS restrictions from the mifepristone abortion drug.

Medical Devices

AdvaMed Supports Diagnostics Reforms in User Fee Reauthorization

The Advanced Medical Technology Association urges the House and Senate to come to terms on a FDA user fee reauthorization package that includes diagno...