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Latest FDA Warning Letters

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FDA releases its latest batch of Warning Letters that includes Global Treat Srl, Mandelay Kft and Philip Kennedy.

Notice Corrected on ANDA Approval Withdrawals

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Federal Register notice: FDA corrects a 1/8 Federal Register notice that announced the withdrawal 23 ANDAs.

GAO Report Examines NDA Review Times

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A new Government Accountability Act report examines 637 NDAs submitted between 2014 to 2018 and found that review times were mainl...

Info Collection on Service Delivery Feedback

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Federal Register notice: FDA seeks comments on an information collection extension for Generic Clearance for the Collection of Qua...

Info Collection on Cell, Tissue Product Registration

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Federal Register notice: FDA sends to OMB an information collection extension for Human Cells, Tissues, and Cellular and Tissue-Ba...

Device User Fee Reauthorization Meeting 5/5

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Federal Register notice: FDA reschedules for 5/5 its public meeting entitled Medical Device User Fee Amendments for Fiscal Years 2...

CDRH Use of Teleconferences Extended

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As CDRH focuses on coronavirus-related activities, the Center extends its reliance on teleconferences in lieu of in-person meeting...

Enforcement Discretion on Infusion Pump Modifications

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FDA posts a final guidance entitled Enforcement Policy for Infusion Pumps and Accessories During the Coronavirus Disease 2019 (Cov...

Guide on Outsourcing Facility Fees

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FDA posts a final guidance on Fees for Human Drug Compounding Outsourcing Facilities Under Sections 503B and 744K of the FD&C Act....

Reblozyl Approved for Myelodysplastic Syndromes

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FDA approves a Bristol Myers Squibb and Acceleron Pharma BLA for Reblozyl (luspatercept-aamt) for treating anemia after failing an...