FDA Related News

Federal Register

Science Advisory Board Meeting Announced

Federal Register notice: FDA announces an 11/6-7 Science Advisory Board to the National Center for Toxicological Research meeting.

Medical Devices

SCOTUS May Consider FDA Status in Device Suits

An Alston & Bird client alert says the Supreme Court will decide whether to hear an appeal of a case that asks whether medical device manufacturers ca...

Human Drugs

FDA Opens NextGen Collaboration Portal

CDER opens its Direct NextGen Collaboration Portal through which industry can request pre-ANDA meetings for complex generic drug products.

Human Drugs

McGuff NDA for Ascor Approved by FDA

FDA approves a McGuff Pharmaceuticals NDA for Ascor (ascorbic acid injection USP), a vitamin C drug product for up to one week of scurvy treatment in ...

Medical Devices

FDA Approves Roches Cobas Zika Test

FDA approves a Roche Molecular Systems PMA for the cobas Zika test, a qualitative nucleic acid test for detectimg Zika virus RNA in individual plasma ...

Human Drugs

FDA Spent PDUFA Fees Appropriately: OIG

FDA has generally spent PDUFA user fee collections appropriately, according to an HHS Inspection General report.

Medical Devices

FDA Clears Nexxt Spine 3-D Printing for Interbody/Vertebral Devices

FDA clears a Nexxt Spine 510(k) for the Nexxt Matrixx System, 3-D printed porous titanium equipment for creating interbody and vertebral body replacem...

Noninferiority Trials Can Identify Innovations: Study

Harvard Medical School researchers suggest ways to improve noninferiority clinical trials.

Human Drugs

FDA Approves Mylans Generic Copaxone Copies

FDA approves a Mylan ANDA for glatiramer acetate injection 40 mg/mL and 20 mg/mL, AP-rated, substitutable generic versions of Tevas multiple sclerosis...

Federal Register

Comments Sought on Pregnancy Labeling Requirements

Federal Register notice: FDA requests comments on an information collection extension for Content and Format of Labeling for Human Prescription Drugs ...