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Animal Drugs

Animal Drug Compounding Guidance

FDA publishes a final guidance on its approach to enforcement involving animal drugs compounded from bulk drug substances.

Marketing

Golfer James Hahn Promoting Licart

Pro golfer James Hahn is partnering with IBSA Pharma to promote its Licart prescription topical NSAID.

Medical Devices

FDA STeP Designation for Pear Pain Product

FDA grants Safer Technologies Program designation for a Pear Therapeutics pain control device.

Biologics

Aeglea Bio BLA for Arginase 1 Deficiency

Aeglea BioTherapeutics files a BLA for pegzilarginase for treating Arginase 1 Deficiency.

Medical Devices

Boston Scientific Brain Stimulator Programming Software OKd

FDA approves a Boston Scientific PMA for its latest image guided programming software, Vercise Neural Navigator with StimViewXT, for use in brain stim...

Human Drugs

Three ICH Guidelines Reach Stage 2

The International Council on Harmonization says three guidelines are at Stage 2 and open for public comment.

Human Drugs

Apply for Naloxone OTC: Lawmakers

Some 30 House and Senate members ask CEOs of seven manufacturers of naloxone to seek OTC status for their drug.

Medical Devices

FDA Convening Panel on Virtual Reality Devices

FDA announces a 7/12-13 CDRH Patient Engagement Advisory Committee meeting that will discuss and make recommendations on augmented reality and virtual...

Human Drugs

Multiple Violations at Generitech

FDA warns Fresno, CA-based Generitech Corp. about multiple repeat violations in its production of finished drugs.

Federal Register

Otect Not Withdrawn Due to Safety/Efficacy: FDA

Federal Register notice: FDA determines that Clinigens Otect (dexrazoxane hydrochloride) for injection was not withdrawn due to safety or effectivenes...