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FDA Approves Amgens Biosimilar Version of Humira

[ Price : $8.95]

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...

Office of Clinical Pharmacology Good Review Practices

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CDER issues a MAPP outlining good review practices for the Office of Clinical Pharmacology review of NMEs, NDAs, and BLAs.

FDA Clears GI View Aer-O-Scope

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FDA clears a GI View Ltd. 510(k) for its new Aer-O-Scope Colonoscope System, a disposable, self-propelled, joystick-controlled, co...

Magnetic Surgical Instrument Device Classified as Class 2

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Federal Register Final Order: FDA classifies the Magnetic Surgical Instrument System into Class 2 (special controls).

Product Radiation Committee to Mull Device Performance Standards

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Federal Register Notice: FDA announces a 10/25-26 public advisory committee meeting of the Technical Electronic Product Radiation ...