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Omni Bio Pharmaceutical Initiates Trial in Type 1 Diabetes

[ Price : $8.95]

Omni Bio Pharmaceutical reports the first patient has been infused with Alpha-1 antitrypsin in an FDA-cleared Phase 1/2 clinical t...

FDA Sends Info on Testing Communications on Devices to OMB

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Federal Register Notice: FDA sends a proposed collection of information on testing communications on medical devices and radiation...

Comments Extended on Device User Fee Program

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Federal Register Notice: FDA extends to 11/1 the comment period on the agencys medical device user fee program and the next reauth...

First Post-cataract Extraction Daily Pain Drops OKd for ISTA

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FDA approves ISTA Pharmaceuticals Bromday bromfenac solution for what the company says is the first once-daily Rx eye drop for pos...

McNeil Recalls 1 Lot of 'Musty' Tylenol

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McNeil Consumer Healthcare recalls one lot of Tylenol 8 Hour caplets 50 count bottles after receiving complaints of a musty or mol...

Clinical Source Data MAPP Out

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CDERs Office of New Drugs publishes a MAPP on proper use of clinical source data to audit applicants endpoint adjudication process...

CMC Biotherapeutic Product Guidance Out

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FDA publishes a guidance to help IND sponsors know what chemistry, manufacturing, and control information should be submitted in a...

FDA Fast Track for Cell Therapy

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FDA grants fast track status to Aastrom Biosciences for its critical limb ischemia cell therapy development program.

Buehler Leaving FDA for Teva

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Former Office of Generic Drugs director Gary Buehler is becoming Tevas vice president of regulatory strategic operations.

FDA Rejects Some Generic Ambien Bioequivalency Tests

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FDA rejects a Sanofi-Aventis request on bioequivalence testing for generic Ambien CR products.