FDA Related News

Human Drugs

Guide on Bioequivalence Studies with Pharmacokinetic Endpoints

FDA posts a revised draft guidance entitled Bioequivalence Studies with Pharmacokinetic Endpoints for Drugs Submitted Under an ANDA.FDA posts a revise...

FDA General

Biden Retreats From Woodcock Commissioner Nomination

The Biden Administration reportedly rules out nominating FDA acting commissioner Janet Woodcock for the agencys top post due to lawmakers objections....

CDER Examining Misleading Images in DTC Ads

CDER drug promotion researchers evaluate how images can offer misleading perceptions in direct-to-consumer drug ads, and develop validated instruments...

Human Drugs

FDA Grants Covis Hearing Request on Makena

FDA approves a Covis Pharma request for a hearing on CDERs proposal to withdraw approval for Makena.

Marketing

Sponsored Links Misbrand Eton Alkindi Sprinkle: OPDP

The CDER Office of Prescription Drug Promotion cautions Eton that online sponsored links for its Alkindi Sprinkle dont contain any needed risk informa...

Human Drugs

FDA Says Pfizer Expands Chantix Recall Again

FDA says Pfizer has recalled four additional lots of Chantix due to the presence of an unacceptable level of N-nitroso-varenicline.

Human Drugs

FDA Fast Track Designation for Senhwas Silmitasertib

FDA grants fast track designation to Senhwa Biosciences silmitasertib for treating recurrent sonic hedgehog medulloblastoma.

Medical Devices

FDA Clears Qure.ai qER-Quant for Brain CT Scans

FDA clears a Qure.ai brain imaging quantification product.

Drug, Device Recalls Continue to Go Down: Sedgwick

The Sedgwick recall index says both medical device and pharmaceutical recalls continued to drop in the second quarter of 2021, hitting new lows.

Medical Devices

FDA Clears Zimmer Biomet Rosa Hip

FDA clears a Zimmer Biomet 510(k) for its Rosa Hip System for robotically-assisted direct anterior total hip replacement.