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Committee to Discuss Hypogonadism Drug Trial Designs

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Federal Register Notice: FDA announces a 12/6 meeting of its Bone, Reproductive and Urologic Drugs Advisory Committee that will di...

Fycompa Regulatory Review Period for Patent Extension

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Federal Register Notice: FDA detemines the regulatory review period for Eisais NDA for Fycompa (perampanel) that applies to a pate...

Myalept Regulatory Review Period for Patent Extension

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Federal Register Notice: FDA determines the regulatory review period for an Amylin Pharmaceuticals NDA for Myalept (metreleptin fo...

Belviq Regulatory Review Period for Patent Extension

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Federal Register Notice: FDA determines the regulatory review period for an Eisai NDA for Belviq that applies to a patent extensio...

FDA Approves Amgens Biosimilar Version of Humira

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FDA approves Amgens Amjevita, a biosimilar copy of Abbotts Humira (adalimumab) for multiple inflammatory diseases.

Teva Plans NDA for Tardive Dyskinesia Drug

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Teva Pharmaceutical Industries plans an NDA for the end of the year after reporting statistically significant results in a second ...

FDA Policy Makes Journalist Watchdogs into Lapdogs: Analysis

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Journalism professor Charles Seife faults FDA and reporters for a situation in which journalists are willing to trade early access...

Look at FDA Enforcement and 1st Amendment: MIWG

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The Medical Information Working Group asks a Massachusetts federal court to look at FDA enforcement against off-label promotion in...

Generic Drug Facility Self-Identification Guidance

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FDA issues a guidance to help generic drug facilities, sites, and organizations know what is required from them for their annual e...

Pediatric Voucher Program Expires October 1

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Attorney Alexander Varond reviews several potential routes to reauthorization of the FDA pediatric voucher program that expires 10...