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FDA General

Latest Federal Register Notices

FDA Review posts Federal Register notices for the week ending 6/16/2016.

Human Drugs

FDA Alert on Pfizer/Hospira Drug Shortages

FDA alerts healthcare professionals about an ongoing drug shortage situation affecting several injectable drugs made by Pfizers Hospira unit, includin...

Human Drugs

Advance Pharms Recalls Nitroglycerin Due to Potency

Advanced Pharma recalls all unexpired lots of nitroglycerin products that were produced at its Houston location between 3/3 and 5/31.

Animal Drugs

CVM Announces New Study Grants Program

CVM announces a new program for grants as high as $450,000 to support the development of designated new animal drugs intended for minor species or min...

Medical Devices

37% of Heater-Cooler Devices Reviewed are Contaminated: Research

New research finds that 37% heater-cooler units assessed between 7/2015 and 12/2016 tested positive for Mycobacterium chimaera, a bacterium associated...

Human Drugs

FDA OKs Label Changes for Abbotts Kaletra

FDA approves changes to Abbotts Kaletra (lopinavir/ritonavir) tablet and oral solution labels, for treating adult patients with HIV who have previousl...

Federal Register

FDA Seeks Nominations for Radiation Standards Panel

Federal Register notice: FDA requests nominations for members to serve on CDRHs Technical Electronic Product Radiation Safety Standards Committee.

Federal Register

FDA Seeks Consumer Reps for Advisory Panels

Federal Register notice: FDA requests nominations for voting and nonvoting consumer representatives to serve on advisory committees and panels.

Human Drugs

FDA Accepts Sandoz ANDA for Generic Advair Diskus

FDA accepts for review a Sandoz ANDA for fluticasone propionate/salmeterol combination product, a generic version of GlaxoSmithKlines asthma product A...

Human Drugs

AMA Wants More Drug Price Transparency

Delegates at the American Medical Association annual meeting approve policies intended to bring greater transparency to drug pricing.