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FDA issues a draft guidance with recommendations for drug application sponsors about nonclinical studies to identify potential end...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

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...

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...

FTC Commissioner Makes Case Against Pay-for-Delay

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FTC commissioner Julie Brill makes the case for working to overturn anti-competitive pay-for-delay settlements.

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.

Many Changes Sought in Cyber Security Guidance

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Stakeholders call on FDA to make significant changes to a draft cyber security guidance document for medical devices.

Oversight Board Discusses Medical Product Safety

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The FDA Drug Safety Oversight Board discusses medical product safety objectives being sought by the agency through its work with H...

Shamrock Medical Solutions Group Consent Decree Approved

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An Ohio federal judge approves a permanent injunction sought by FDA against Shamrock Medical Solutions Group for drug GMP and labe...