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Teva Petitions FDA to Block ANDAs for Treanda

[ Price : $8.95]

Teva petitions FDA asking it not to approve any ANDAs that reference Treanda (bendamustine hydrochloride) until its orphan exclusi...

FDA Guidance on Developing HIV Therapies

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FDA posts a guidance on Human Immunodeficiency Virus-1 Infection: Developing Antiretroviral Drugs for Treatment that provides reco...

FDA Breakthrough Status for Giant Cell Tumor Therapy

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FDA grants Daiichi Sankyo and Plexxikon a breakthrough therapy designation for their investigational oral CSF-1R inhibitor pexidar...

OMB OKs Info on Ad Exposure

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Federal Register Notice: The Office of Management and Budget approves a collection of information on the impact of ad exposure fre...

OMB OKs Info on Generic Drug Pill Characteristics

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Federal Register Notice: The Office of Management and Budget approves a collection of information on a survey on the physical char...

13 ANDAs Not Withdrawn for S&E

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Federal Register Notice: FDA determines that 13 ANDAs were not withdrawn from sale for reasons of safety or effectiveness.

FDA Stays Parts of IND Guidance

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Federal Register Notice: FDA announces a stay of portions of its final guidance: Investigational New Drug Applications Determinin...

Public Workshop on Clinical Trial Safety

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Federal Register Notice: FDA plans a public workshop 12/2: Clinical Trials Assessing Safety and Efficacy in Diverse Populations....

Comments Re-opened on Human Cells Guidance

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Federal Register Notice: FDA reopens the comment period for the draft guidance on minimal manipulation of human cells, tissues, an...

Hearing on Human Cells Guidances

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Federal Register Notice: FDA will hold a public hearing 4/13/16 on four recent draft guidance on the regulation of human cells, ti...