FDA Related News

FDA Equitable Remedy Authority in Doubt: Attorneys

Two Hyman, Phelps & McNamara attorneys question whether FDA has authority to seek equitable relief in cases involving violations of the Federal Food, ...

Medical Devices

More Benefit than Risk in Non-Device Software: FDA

FDA says there is more benefit than risk in non-medical device software digital health products.

Human Drugs

FDA Pulls Generic Drug Labeling Safety Update Rule

FDA commissioner Scott Gottlieb says FDA is withdrawing a proposed rule to allow generic drug companies to independently add new safety information to...

Federal Register

Proposed Rule Redefines Biological Product

Federal Register proposed rule: FDA proposes to amend its regulation that defines biological product to incorporate changes made by the Biologics Pric...

Federal Register

Priority Review Voucher Awarded to Novimmune

Federal Register notice: FDA issues a priority review voucher to Novimmune for its approved rare pediatric disease product application for Gamifant (e...

Federal Register

IC-Green Not Withdrawn Due to Safety/Efficacy: FDA

Federal Register notice: FDA determines that Akorns ICGreen (indocyanine green for injection), 10 milligrams (mg)/vial, 40 mg/vial, and 50 mg/vial, wa...

Medical Devices

FDA Changes Medical Device Classification Regs

FDA issues a final rule to update procedures for classifying and reclassifying medical devices to conform to change in the FDA Safety and Innovation A...

Medical Devices

Tangible Science Hydra Contact Lens Cleared

FDA clears a Tangible Science 510(k) for its daily disposable silicone hydrogel contact lens coated with a modified formula of Tangible Hydra-PEG, whi...

Human Drugs

FDA Gives Gibson a Rare Pediatric Disease Designation

FDA grants Gibson Oncology a Rare Pediatric Disease Designation for LMP-400, the companys novel small molecule topoisomerase 1inhibitor for treating E...

Animal Drugs

FDA Works With Pfizer on Animal Opioid Supply

The Center for Veterinary Medicine works with Pfizer to keep a supply of injectable opioids available in the U.S. veterinary market.