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Notice Correction on CDISC Study Data Tabulation

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Federal Register notice: FDA corrects an 8/20 notice to reflect the correct dates that the support and requirement were to begin f...

Guide on What Constitutes an Inspection Delay/Refusal

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Federal Register notice: FDA makes available a draft guidance entitled Circumstances that Constitute Delaying, Denying, Limiting, ...

Updated CVM Guide on Antimicrobial Resistance Risks

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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...

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...

OMB Approves Seven Information Collections

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OMB approves seven information collections that include humanitarian-use devices, Right-to-Try Act reporting, and positron emissio...

Comments on Immune-Mediated Adverse Reaction Guidance

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Three drug companies comment on an FDA draft guidance on immune-mediated adverse reactions in cancer drug trials.