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FDA Nixes Data Fraud Rumors on Sarepta NDA Delay

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In an unprecedented move, FDA issues a statement to clarify that data integrity or fraud is not at the center of why Sarepta Thera...

OIG Work Plan Targets Five FDA Drug Program Areas

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The HHS Office of the Inspector General announces its Work Plan for fiscal year 2015 that targets five FDA drug program areas.

Lannett Gains Approval for Generic Femara

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FDA approves a Lannett Co. ANDA for letrozole tablets USP, 2.5 mg, a generic copy of Novartis Femara tablets.

FDA Panel Backs Daiichi Sankyo Stroke Drug

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FDAs Cardiovascular and Renal Drugs Advisory Committee recommends approval of Daiichi Sankyos once-daily Savaysa (edoxaban) 60 mg ...

Info on Commissioners Fellowship Program Sent to OMB

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Federal Register Notice: FDA submits a proposed collection of information to the Office of Management and Budget on the FDA commis...

FDA Corrects Notice on Recordkeeping for Exports

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Federal Register Notice: FDA corrects a notice on exports and notification and recordkeeping requirements.

Several Drug Products Not Withdrawn for S&E

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Federal Register Notice: FDA determines that several drug products were not withdrawn from sale for reasons of safety or effective...

FDA OKs TWi Pharmas Generic Aricept

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FDA grants final approval to TWi Pharmaceuticals for its ANDA for a generic version of Eisais Aricept, 23 mg to treat Alzheimers d...

Amgen Asks for Biosimilar Submission Alerts to Innovators

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Amgen petitions FDA to require biosimilar applications to include a certification by the applicant that they will provide the refe...

First Custom Design Exemption Report Due in March

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A CDRH Webinar on a recent custom design exemption guidance confirmed that the first annual report mandated by the guidance is due...