FDA Related News

Federal Register

Cell/Tissue Product Registration Info Collection

Federal Register notice: FDA seeks comments on an information collection extension for Human Cells, Tissues, and Cellular and Tissue-Based Products: E...

Human Drugs

ViiV Files NDA for HIV Drug

ViiV Healthcare files an NDA for fostemsavir, an investigational, first-in-class attachment inhibitor for treating HIV-1 infection.

Federal Register

Nonvoting Device Industry Reps for Panels Sought

Federal Register notice: FDA requests that any industry organizations interested in participating in selecting nonvoting industry representatives to s...

CDRH, CDER Differ on Releasing Gender Info

An International Consortium of Investigative Journalists report finds that unlike CDER, CDRH refuses to make public MAUDE data on patients sex, age, a...

Medical Devices

FDA Authorizes Roche MRSA Detection Test

FDA authorizes Roche to market its cobas vivoDX MRSA diagnostic test that speeds the detection of MRSA using new technology.

Biologics

Chara Biologics Markets Unapproved Cell Product: CBER

CBER says Chara Biologics is marketing its CharaCore cell product to treat serious diseases and conditions without agency approval.

Human Drugs

FDA Approves 3 ANDAs for Generic MS Drug

FDA approves three ANDAs for the first generics of Novartis Gilenya (fingolimod) capsules for treating relapsing forms of multiple sclerosis in adult ...

Human Drugs

FDA Launches CURE ID Internet Repository

FDA launches its CURE ID Internet-based repository for reporting experiences using approved drugs in new ways to treat hard-to-treat diseases.

Human Drugs

Genus Lifesciences Protests FDA Actions on Lannett Application

Genus calls on FDA to rescind its acceptance of a Lannett 505(b)(2) application for a cocaine hydrochloride product.

Medical Devices

Groups Question FDA Weight Loss Paper

Several professional groups take issue with provisions in an FDA discussion paper on a benefit/risk approach for medical devices for weight loss.