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Glaxo Resuming Some Doctor Payments

GlaxoSmithKline reverses a 2013 policy and will pay some doctors for promoting some of its drugs.

Human Drugs

FDA Clears CarboFix Carbon Fiber Connectors

FDA clears a CarboFix in Orthopedics 510(k) for the CarboClear Carbon Fiber Transverse Connectors to be used in conjunction with its Carbon Fiber Pedi...

Human Drugs

Liveyon Recalls Stem Cell Product

Liveyon recalls all ReGen Series stem cells due to reported adverse reactions.

Federal Register

Guide on Atopic Dermatitis Pediatric Studies

Federal Register notice: FDA makes available a guidance entitled Atopic Dermatitis: Timing of Pediatric Studies During Development of Systemic Drugs....

Human Drugs

Fast Track for VistaGen Non-opioid Pain Killer

FDA grants VistaGen Therapeutics a fast track designation for AV-101, a non-opioid, non-sedating treatment for neuropathic pain.

Medical Devices

QS, MDR Violations at Datascope

FDA warns Datascope Corp. about Quality System and Medical Device Reporting violations in its manufacturing of several medical devices.

Human Drugs

FDA Revises 505(q) Petition Guidance

FDA commissioner Scott Gottlieb says a revised draft guidance should improve the predictability and efficiency of generic drug reviews by addressing c...

Federal Register

Panel to Hear DNA Virus Lab Research

Federal Register notice: FDA announces an 11/8 Vaccines and Related Biological Products Advisory Committee meeting to hear an overview of a research p...

Human Drugs

Lilly Plans 2019 NDA for Diabetes Therapy URLi

Eli Lilly plans to submit an NDA for Ultra Rapid Lispro in 2019 after reporting favorable clinical trial data from two Phase 3 trials.