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Its Official, OIA Stripped of Internal Probes

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Effective 11/30, FDAs Office of Internal Affairs loses its authority to investigate agency employees for alleged criminal miscondu...

FDA OKs Expanded Use for Cymbalta

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FDA approves an Eli Lilly supplemental NDA for Cymbalta and its use for maintenance treatment of major depressive disorder in adul...

FDA Grants Arimidex Pediatric Exclusivity

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FDA approves six-months pediatric exclusivity for AstraZenecas Arimidex.

Pipex Pharmaceuticals NDA for Wilsons Disease

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Pipex Pharmaceuticals files an NDA for Coprexa, indicated for treating Wilsons disease.

FDA Accepts UCB NDA for Diabetic Pain

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FDA accepts for review a UCB NDA for Vimpat (lacosamide), indicated for treating diabetic neuropathic pain.

Senator Investigating Avastin Availability

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Sen. Herb Kohl asks FDA for detailed information on Genentechs decision to limit availability of its Avastin to certain compoundin...

Advocate Backs Learned Intermediary End

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Government Accountability Project executive director Mark Cohen says more states should drop the learned intermediary doctrine and...

UK Drug Regulator Reports Fewer Ad Complaints

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The UKs health products regulator says its increased review of new drug launches and ads has led to fewer complaints and fewer cor...

Asthma Drugs Safety Review Calls for Stronger Warning

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FDA plans to study the safety of asthma drugs used in children after an advisory panel recommends a stronger warning on long-actin...

Roche to Stop Making Roferon-A

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Roche tells FDA that is discontinuing production and marketing of Roferon-A (Interferon alfa-2a, recombinant) due to product lifec...