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Guidance on Liposome Drug Products

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Federal Register Notice: FDA releases a draft guidance: Liposome Drug Products: CMC; Human Pharmacokinetics and Bioavailability; a...

510(k) Devices Take 94% of Post-market Surveillance Studies: GAO

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A Government Accountability Office analysis of FDA-ordered postmarket surveillance studies between 3/2008 and 2/2015 finds that 94...

Comments Re-opened on Adipose Tissue Guidance

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Federal Register Notice: FDA reopens the comment period on a draft guidance: Human Cells, Tissues, and Cellular and Tissue-Based P...

Lipocine NDA Filed for Testosterone Product

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FDA accepts for filing a Lipocine NDA for LPCN 1021, an oral product candidate for testosterone replacement therapy in adult males...

Guidance on Homologous Use of Human Cells et

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Federal Register Notice: FDA releases a draft guidance: Homologous Use of Human Cells, Tissues, and Cellular and Tissue-Based Prod...

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13 ANDAs Not Withdrawn for S&E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Federal Register Notice: FDA determines that 13 ANDAs were not withdrawn from sale for reasons of safety or effectiveness.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