FDA Related News

Drug Recalls Up, Device Recalls Down: Report

The Stericycle recall index for the third quarter of 2020 finds that drug recalls nearly doubled, while medical device recalls fell by one-third.

Human Drugs

BPCIA and Biosimilar Development Q&A

FDA issues a draft guidance with additional questions and answers on biosimilar development and the Biologics Price Competition and Innovation Act.

Human Drugs

FDA Will Review Alvotech BLA for Humira Biosimilar

FDA has accepted for review an Alvotech USA BLA for a Humira biosimilar.

Federal Register

FDA Adds More ANDA-specific Bioequivalence Guidances

Federal Register notice: FDA posts 30 additional draft and revised draft product-specific guidances on the design of bioequivalence studies to support...

Federal Register

FDA Debarment Order Against Ex-Insys Manager

Federal Register notice: FDA issues an order permanently debarring Richard M. Simon from providing services in any capacity to a person that has an ap...

Marketing

OPDP Core Launch Review Process Updated

An 11/20 CDER Webinar will explain changes to the Office of Prescription Drug Promotion core launch review process.

Biologics

Vaccine Electronic Safety Report Info

FDA posts online information for vaccine manufacturers to submit safety reports electronically to CBER.

Medical Devices

Armis Biopharmas Toe Implant Approved

FDA approves Armis Biopharmas VeriFixx Small Bone Implant for the fixation of osteotomies and reconstruction of the lesser toes following correction p...

Biologics

Regenerative Cell Institute Illegally Marketing Cellular Products: FDA

FDA says Regenerative Cell Institute in Las Vegas is illegally providing cellular products to treat many diseases and conditions.

Medical Devices

FDA Clears EOGas 4 Ethylene Oxide Gas Sterilizer

FDA clears an Andersen Sterilizer 510(k) for its EOGas 4 Ethylene Oxide Gas Sterilizer and associated accessories for sterilizing duodenoscopes and co...