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Survey on Drug Facility Risk Management

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Federal Register notice: FDA seeks comments on a proposed Survey of Drug Product Manufacturing, Processing and Packing Facilities ...

410 Medical Gains Expanded Use for LifeFlow

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FDA clears a 410 Medical 510(k) for its LifeFlow device for rapid delivery of blood and blood components, in addition to its previ...

FDA Makes Changes to Drug Name Program

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FDA makes modernized changes to its Phonetic and Orthographic Computer Analysis (POCA) program, the agencys software tool for dete...

House Panel Denounces Trump Block on Hahn Testimony

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House Energy and Commerce Committee leadership denounces the White House after it blocked FDA commissioner Stephen Hahn from testi...

Medimetriks Cutting Phase 3 Enrollment After FDA Meeting

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Medimetriks Pharmaceuticals says it received a Type C Meeting written response from FDA on MM36 (difamilast) for the topical treat...

Junshi Bio Orphan Status for Soft Tissue Sarcoma

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FDA grants Junshi Biosciences an orphan drug designation for toripalimab and its use in treating soft tissue sarcoma.

OPDP Looking at Medical Conference Drug Promotion

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The CDER Office of Prescription Drug Promotion says it wants to ask medical conference healthcare professional attendees about the...

FDA Publishes Covid-19 Molecular Test Comparisons

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FDA publishes a table comparing the performance of over 50 Covid-19 molecular diagnostic tests.

Acutus Medical 3D Imaging and Mapping Catheter

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FDA clears a Acutus Medical 510(k) for the second-generation AcQMap 3D imaging and mapping catheter.

Historic Data Show Vaccine Approval Risks: Lurie

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Former FDA associate commissioner Peter Lurie says historic data on vaccine trials should lead to a realistic understanding that s...