FDA Related News

Human Drugs

Failure to Respond to ANDA Complete Response Letters: Guide

FDA releases a final guidance entitled Failure to Respond to an ANDA Complete Response Letter Within the Regulatory Timeframe.

Human Drugs

FDA Posts Q & A Guide on Orange Book

FDA posts a final guidance entitled Orange Book Questions and Answers that answers commonly asked questions it has received from interested parties.

Medical Devices

Compliance Extension Date on Unique Device IDs

FDA posts an updated final guidance entitled on the unique device identification compliance date for class i and unclassified devices that extends the...

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Federal Register notice: FDA makes available a draft guidance entitled Human Prescription Drug and Biological Products Labeling for Dosing Based on W...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Federal Register notice: FDA has made available a draft guidance entitled Evaluation of Therapeutic Equivalence that explains how it evaluates generic...