FDA Related News

Biologics

Panel Backs Pfizer, Moderna Covid Vaccines in Young Kids

FDAs Vaccines and Related Biological Products Advisory Committee unanimously votes to recommend the agency expand the Covid-19 emergency use authoriza...

Medical Devices

Quantitative Imaging Assessment in Premarket Submissions

FDA publishes a guidance with recommendations for manufacturers on information to go in premarket submissions for radiological devices with quantitati...

FDA General

Alliance Supports FDA Funding Bill

The Alliance for a Stronger FDA says it supports the FDA funding proposed by a House Agriculture Appropriations subcommittee.

Human Drugs

Make Oral Contraceptives OTC: AMA

The American Medical Association calls on FDA to approve a switch of hormonal oral contraceptives from prescription to over-the-counter status.

Human Drugs

Generic Drug Covid-19 Successes Touted

CDER director Patrizia Cavazzoni praises accomplishments in the generic drug program during Covid-19.

Medical Devices

FDA Update on Heater-Cooler Devices

FDA provides an update on its ongoing monitoring of heater-cooler devices and the risk of nontuberculous mycobacteria infections in patients who have ...

Human Drugs

Objectionable Conditions in 2 Clinical Trials

FDA warns Smitha Reddy and her Poway, CA-based ACRC Studies facility about objectionable conditions in conducting two clinical investigations.

Human Drugs

Outsourcing Facility Producing Illegal Drugs: FDA

FDA warns Deerfield Beach, FL-based Hybrid Pharma about multiple violations in its work as an outsourcing facility.

Human Drugs

Alnylam Pharma Amyloidosis Therapy Approved

FDA approves an Alnylam Pharmaceuticals NDA for Amvuttra (vutrisiran), an RNAi therapeutic administered by subcutaneous injection once every three mon...

FDA Draft Trial Diversity Guidance Outlined

Troutman Pepper attorneys discuss a new FDA draft guidance giving sponsors information on presenting diversity plans to enroll under-represented popul...