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FDA Issues Report on Chronic Fatigue Meeting

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FDA issues a report summarizing the presentations and discussion at a PDUFA 5 Voice of the Patient public meeting on chronic fatig...

Medical Device Single Audit Pilot Begins January

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CDRH international affairs associate director Kim Trautman updates an industry conference on a Center-backed medical device single...

FDA Publishes Safety Evaluation Summary

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FDA publishes a summary of its safety evaluation of drugs and biologics from April to June.

Endocrine Disruption Guidance Out

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FDA issues a draft guidance with recommendations for drug application sponsors about nonclinical studies to identify potential end...

GPhA Asks for Naming Policy for All Biologics

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GPhA asks FDA to assign the same International Non-proprietary Naming names to biosimilars and their reference protein products.

FDA Clears Crosstrees PVA Pod System

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FDA clears a Crosstrees Medical 510(k) for the Crosstrees PVA Pod System for Percutaneous Vertebral Augmentation.

Changes Sought in Pediatric Study Plan Guidance

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BIO asks FDA for an optional more comprehensive approach to pediatric drug development.

Most DTC and OTC Drug Ads Misleading: Study

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Researchers say that 60% of Rx drug TV ads and 80% of OTC drug TV ads contain false or potentially misleading statements.

Public Hearing on Emergency Eye Wash Products

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Federal Register Notice: FDA plans a public hearing 12/4 to the formulation, manufacturing, and labeling of currently marketed eme...

CDER to Target Contract Manufacturing and Quality Agreements

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CDER Office of Compliance deputy director Ilisa Bernstein says her office is ratcheting up its surveillance of drug sponsors use o...