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

GDUFA Completeness Assessment Guidance Out

FDA issues a guidance explaining GDUFA requirements for holders of Type II API DMFs referenced in ANDAs, PSAs, or amendments to either of them.

Human Drugs

FTC Sets Drug Competition Workshop

The Federal Trade Commission sets an 11/8 workshop on drug market competition with an address by FDA commissioner Scott Gottlieb.