FDA Related News

Federal Register

Allergenic Panel Meeting Canceled

Federal Register notice: FDA cancels a 5/15 Advisory Committee meeting due to outstanding review issues related to the safety and efficacy of DBV Tech...

Federal Register

Modified Device Consensus Standards Listing

Federal Register notice: FDA modifies the list of standards it recognizes for use in medical device premarket reviews.

Medical Devices

FAQ on 3D Printing of Medical Devices

FDA posts Frequently Asked Questions on 3D Printing of Medical Devices, Accessories, Components, and Parts During the Covid-19 Pandemic.

Human Drugs

FDA Nixes Trump Again on Chloroquine Use

Despite repeated urging from president Trump to use the malaria drug chloroquine to treat coronavirus patients, FDA reiterates that a randomized contr...

6 Observations on Innovative Compounding FDA-483

FDA releases the FDA-483 with six observations from a 2017 inspection at Innovative Compounding Pharmacy.

Medical Devices

FDA Emergency Use Authorization for Ventilators

FDA issues an emergency use authorization for ventilators, anesthesia gas machines modified for use as ventilators, and positive pressure breathing de...

Human Drugs

Teva Says Copaxone Should Have a BLA

Teva sues FDA to force it to transition the NDA for Copaxone to a BLA as required under the Biologics Price Competition and Innovation Act.

Human Drugs

Innocoll NDA Resubmitted for Pain Product

FDA accepts an Innocoll Holdings NDA resubmission for post-surgical pain product Xaracoll (bupivacaine hydrochloride collagen-matrix implants).

Human Drugs

FDA OKs Xellia Pharma Cleveland Sterile Drug Plant

FDA approves Xellia Pharmaceuticals Cleveland, OH manufacturing site to make anti-infective drug products for the U.S. market.

Human Drugs

FDA Approves BMS Zeposia for Relapsing MS

FDA approves Bristol-Myers Squibbs Zeposia, a new oral treatment for relapsing multiple sclerosis.