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Info Collection on Drug Maker Emergency Plans

[ Price : $8.95]

Federal Register notice: FDA seeks comments on an information collection extension entitled Planning for the Effects of High Absen...

Type 5 DMFs for Drug-led Combo Product Guide

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FDA posts a draft guidance on Type V DMFs for CDER-Led Combination Products Using Device Constituent Parts with Electronics or Sof...

FDA Fact Sheet on Device Consensus Standards Pilot

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FDA releases a fact sheet to explain its Accreditation Scheme For Conformity Assessment (ASCA) Pilot Program: Draft Guidance.

Allergan Pays $750 Million on Namenda Switch Scheme

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Allergan and its Forest Laboratories subsidiaries agree to pay $750 million to settle a lawsuit brought by direct purchasers of Al...

Melintas Baxdela Expanded Approval for Pneumonia

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FDA approves a Melinta Therapeutics supplemental NDA for Baxdela (delafloxacin) for treating adult patients with community-acquire...

NuCana Phase 3 Bilary Tract Cancer Study

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FDA authorizes NuCana to begin a Phase 3 study (nutide:121) of the investigational drug Acelarin in combination with cisplatin for...

Orthopedic Surgical Instruments Put Into Class 2

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Federal Register notice: FDA classifies orthopedic surgical instrumentation designed for osteochondral implants with press-fit fix...

Draft Guide on Homeopathic Drug Products

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Federal Register notice: FDA makes available a revised draft guidance entitled Drug Products Labeled as Homeopathic.

Allergan NDA Lo Minastrin FE Withdrawn

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Federal Register notice: FDA withdraws the NDA approval of Allergan Pharmaceuticals Lo Minastrin FE because it is no longer market...

Internal Therapeutic Massagers Put Into Class 2

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Federal Register notice: FDA classifies internal therapeutic massagers into Class 2 (special controls).