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Human Drugs

Perrigo Tentative Approval for Acne Generic Drug

FDA tentatively approves a Perrigo ANDA for a generic version of Valeant Pharmaceuticals acne drug Onexton Gel (clindamycin phosphate 1.2% and benzoyl...

Human Drugs

Court Remands Amgen Dispute to FDA for Further Consideration

The Washington DC District Court remands to FDA an Amgen lawsuit against the agency over its denial to grant pediatric exclusivity for the companys Se...

FDA General

FDA Monkey Study Axed Over Inhumane Treatment Concern

FDA commissioner Scott Gottlieb orders the termination of an agency-sponsored animal (monkey) study of nicotine exposure over inhumane treatment conce...

Medical Devices

Hologic PMA Approved for Hepatitis B Assay

FDA approves a Hologic PMA for the Aptima HBV Quant Assay for calculating hepatitis B viral load on the fully automated Panther system.

Human Drugs

Hitachi Device Cleared for Irradiating Tumors

FDA clears a Hitachi 510(k) for its Real Time Image Gating System for Proton Beam Therapy Systems for treating cancer patients.

Federal Register

Regulatory Review Period Determined for Varubi

Federal Register notice: FDA determines for patent extension purposes the regulatory review period for OPKO Healths Varubi (rolapitant) to be 3,070 da...

Federal Register

Pharma Science Panel Renewed

Federal Register notice: FDA announces that its Pharmaceutical Science and Clinical Pharmacology Advisory Committee has been renewed for an additional...

Federal Register

Rule Issued on Biologic Inspection Timing, Requirements

Federal Register direct final rule: FDA amends its general biologics regulations relating to time of inspection requirements and to remove duties of i...

Factors for Dismissing Whistleblower Cases

The Justice Department lists seven factors for attorneys to consider when evaluating whether to seek dismissal of a whistleblower suit.

Human Drugs

FDA Nixes Braeburn Opioid Disorder Drug

FDA sends Braeburn Pharmaceuticals a complete response letter on an NDA for CAM2038, an investigational buprenorphine weekly and monthly depot injecti...