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Tarcevas Review Period is Determined

[ Price : $8.95]

Federal Register Notice: FDA determines the regulatory review period for patent extension for Pfizers Tarceva.

FDA OKs Pfizer sNADA for Bovine Respiratory Disease

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Federal Register Final rule: FDA approves a Pfizer supplemental NADA to add a pathogen to the indication for using tulathromycin t...

FDA Accepts Biolase Response to Warning Letter

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FDA notifies Biolase Technology that a company response to FDAs 9/5 Warning Letter is adequate.

FDA Mulls New Data on Bayers Trasylol

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FDA reemphasizes a safety alert on Bayers Trasylol as it reviews just-submitted data that the company says it mistakingly did not ...

WLF Petitions FDA to Stop Actions Against Home Brew Tests

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WLF petitions FDA to stop enforcing medical device regulations against clinical laboratories that provide physicians with in-house...

FDA Approves Sparhawk Labs ANADA

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Federal Register Final rule: FDA approves a Sparhawk Labs ANADA for using neomycin sulfate soluble powder in livestock for treatin...

Merck Launches Online Doctors Bag

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Merck offers consumers Doctors Bag, an online search tool accessing ad-free credible and unbiased health information.

Merck Says Educational Content was Lacking

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The UK Prescription Medicines Code of Practice Authority makes an example of Merck with journal ads criticizing the company for a ...

Luitpold Hydralazine HCl Recalled

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FDA says Luitpold Pharmaceuticals has recalled its total supply of hydralazine HCl injection but Abraxis Pharmaceuticals can meet ...

Discovery Says Root Cause Found for Surfaxin Problem

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Discovery Laboratories says it found a probable root cause for a Surfaxin process validation stability failure.