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FDA Debars Varona Over Study Records Fabrication

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Federal Register notice: FDA permanently debars Nayade Varona from providing services to anyone having an approved or pending drug...

Info Collection Extension on Device Sterilization

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Federal Register notice: FDA seeks comments on an information collection extension entitled Agreement for Shipment of Devices for ...

Multiple Violations in NeuroField Inspection

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FDA warns Bishop, CA-based NeuroField about Quality System and other violations in its manufacturing of neurostimulation and elect...

Gene Products Editing Guidance

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FDA publishes a draft guidance with recommendations for sponsors submitting an IND to develop human gene therapy products incorpor...

Merck Scraps Keytruda/Lynparza in Prostate Cancer

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Due to disappointing overall survival data, Merck has stopped its Phase 3 KEYLYNK-010 trial evaluating Keytruda in combination wit...

LuSys Labs Covid Tests Recall Class 1

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FDA classifies as Class 1 a LuSys Laboratories recall of its Covid-19 antigen tests (nasal/saliva) and Covid-19 IgG/IgM antibody t...

CAR T Cell Product Development Guidance

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FDA publishes a draft guidance with CAR T cell-specific recommendations about chemistry, manufacturing, and control; pharmacology ...

FDA Approves Mylan Symbicort Generic

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FDA approves Mylans generic Symbicort for asthma and COPD patients.

Bill with FDA Responsibilities Moves to Senate Floor

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A Senate pandemic-related bill that outlines many new FDA responsibilities heads to the Senate floor for a vote after being marked...

Pfizer/BioNTech File for 2nd Covid Vaccine Booster

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Pfizer and BioNTech file an Emergency Use Authorization application for a second Covid-19 vaccine booster dose in adults 65 years ...