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Guide on What Constitutes an Inspection Delay/Refusal

[ Price : $8.95]

Federal Register notice: FDA makes available a draft guidance entitled Circumstances that Constitute Delaying, Denying, Limiting, ...

Updated CVM Guide on Antimicrobial Resistance Risks

[ Price : $8.95]

FDA issues a draft update to guidance for industry #152, Evaluating the Safety of Antimicrobial New Animal Drugs with Regard to Th...

Providence Medical Tech Cavux Facet Device Cleared

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FDA clears a Providence Medical Technology Cavux Facet Fixation System (FFS) for spinal surgery patients requiring a revision for ...

Aurigene Ditches Psoriasis Drug Candidate

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Dr. Reddys subsidiary Aurigene Oncology halts the development of its psoriasis investigational drug after reporting poor results o...

Draft Guide on Pulmonary Tuberculosis Drugs

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FDA posts a draft guidance entitled Pulmonary Tuberculosis (TB): Developing Drugs for Treatment.

Draft Inspection Refusal Guidance

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FDA publishes a draft guidance defining the types of behaviors that FDA considers to be delaying, denying, or limiting an inspecti...

FDA Stem Cell Therapy Regulation at Risk: Attorneys

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Three Ropes & Gray attorneys describe the potential for a Circuit Courts of Appeals split over FDA authority in regulating stem ce...

FDA Updates CRL Guidance Performance Goals

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FDA publishes a revised guidance incorporating GDUFA 3 performance goals for complete response letter activities.

Updated Xeloda Labeling Approved

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FDA approves revised labeling for Genentechs Xeloda.

FDA Extends Lynparza sNDA Review by 3 Months

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FDA extends by three months its review of an AstraZeneca and Merck supplemental NDA for Lynparza (olaparib) in combination with Ja...