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Latest FDA Warning Letters

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FDA releases its latest batch of Warning Letters that includes Hubei Danjiangkou Danao Pharmaceutical and Vita-Pure.

Medtronic Azure Pacemakers with BlueSync Approved

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FDA approves a Medtronic PMA for its Azure pacemakers with BlueSync technology.

Comments Extended on Cardiac Troponin Assays

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Federal Register notice: FDA extends its comment period provided in a 7/31 Federal Register notice entitled Cardiac Troponin Assay...

Comments Sought on Petition for OTC Denture Repair Kits

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Federal Register notice: FDA seeks comments on a petition from an undisclosed applicant requesting exemption from premarket notifi...

Guide on Same Procedure Exception for Tissue Products

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Federal Register notice: FDA makes available a guidance on Same Surgical Procedure Exception under 21 CFR 1271.15(b): Questions an...

Guide on HCT/P Minimal Manipulation and Homologous Use

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Federal Register notice: FDA makes available a guidance entitled Regulatory Considerations for Human Cells, Tissues, and Cellular ...

White House Puts 2015 Opioid Crisis Cost at $500 Billion

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A new White House report estimates that the ongoing opioid crisis cost the U.S. $504 billion in 2015 and led to over 33,000 Americ...

Janssen Biosimilar Patent Infringement Complaint Filed

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Federal Register notice: FDA acknowledges that an applicant for a proposed biosimilar product notified the agency that a patent in...

Guide on UDI Direct Device Markings

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Federal Register notice: FDA makes available a guidance entitled Unique Device Identification: Direct Marking of Devices.

FDA Approves Kalos AUVI-Q for Infants

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FDA approves a Kalo supplemental NDA for AUVI-Q (epinephrine injection, USP) 0.1 mg, for treating life-threatening allergic reacti...