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3Derm Systems Breakthrough for Skin Cancer AI

[ Price : $8.95]

FDA grants 3Derm Systems a breakthrough device designation for its 3DermSpot, an algorithm that uses artificial intelligence and h...

FDA, Industry Should Better Manage Device Recalls: Study

[ Price : $8.95]

Minneapolis Heart Institute researchers fault FDA and the medical device industry for not better managing and communicating about ...

CDER Program Helping Companies Innovate: Post

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CDER Emerging Technology Team director Sau Lee explains how the program aids industry to innovate and more easily meet regulatory ...

Harvard Reseachers Ask: Why No Generics?

[ Price : $8.95]

Harvard Medical School researchers say policymakers should be looking at high-cost drugs to determine why there arent more generic...

FDA Approves Astellas Mycamine sNDA

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FDA approves an Astellas Pharma supplemental NDA for Mycamine (micafungin for injection) for treating candidemia and acute dissemi...

Petitions Increase Generic Approval Days: Study

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Auburn University researchers say there is a significant increase in the average number of generic drug approval days for drugs fo...

Comments on OND Opportunities, Priorities

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Several stakeholders comment on an FDA reorganization plan for the Office of New Drugs intended to speed and facilitate drug devel...

FDA Onsite Verification of Device Facility Info

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FDA asks for medical device industry cooperation with onsite verification of facility information provided to the agency.

CGMP Violations in Apollo Health Inspection

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FDA warns Canadas Apollo Health and Beauty Care about CGMP violations in its work as a contract manufacturer of OTC drugs.

Enforcement Guide on Nicotine Delivery Systems

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Federal Register notice: FDA makes available a final guidance entitled Enforcement Priorities for Electronic Nicotine Delivery Sys...