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FDA, EMA Liaisons Help Their Agencies

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Former FDA liaison to the European Medicines Agency David Martin says it is important that the two regulatory bodies maintain a li...

OPDP Cites Misleading Sales Aid for Doral

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The CDER Office of Prescription Drug Promotion cautions Sciecure Pharma about false and misleading presentations in a Doral sales ...

FDA Collaborates on Multiple Myeloma Master Protocol

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FDA collaborates with the Multiple Myeloma Research Foundation, the National Cancer Institute, and other groups to accelerate the ...

Changes Highlighted in CDRH Device Recall Guidance

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King and Spalding attorney Pamela Forrest says FDA modified a draft guidance on medical device enhancements and recalls to elimina...

FDA Approves New Cyramza Indication

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FDA approves a new indication for Lillys Cyramza to be used with paclitaxel to treat metastatic gastric or gastroeshopageal juncti...

What's Next for FDA in the New Congress

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FDA Webview examines how the mid-term elections have shaped Congress and whats in store for FDA.

Comments Sought on Appeals Above the Division Level at CVM

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Federal Register Notice: FDA invites comments on the information collection requirements for appeals of science-based decision abo...

Guidance on Facility Identifier for Registration

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Federal Register Notice: FDA releases a guidance: Specification of the Unique Facility Identifier (UFI) System for Drug Establishm...

Guidance on BE Recommendations for Concerta ER

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Federal Register Notice: FDA releases a draft guidance: Bioequivalence Recommendations for Concerta (methylphenidate hydrochloride...

FDA Revokes Ranbaxy Tentative Approvals

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FDA revokes tentative approval decisions granted to Ranbaxy Laboratories for generic copies of AstraZenecas heartburn drug Nexium ...