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CDRH Surveillance/Enforcement on Promo Efforts

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A CDRH official says surveillance and enforcement concerns involving promotional or adverting efforts include unapproved devices, ...

Teva Sues FDA Over Generic Restasis Exclusivity

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Teva asks a federal court to order 180-day exclusivity for its Restasis ANDA.

FDA Clears MC3 Crescent Jugular Catheter

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FDA clears an MC3 510(k) for the Crescent Jugular Dual Lumen Catheter for use in extracorporeal membrane oxygenation.

FDA Wants Generic Drugs Harmonized Globally

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FDA commissioner Scott Gottlieb says the agency is seeking international harmonization of generic drug scientific and technical re...

Eisai Sales Rep Made False, Misleading Statements: OPDP

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CDERs Office of Prescription Drug Promotion cautions Eisai about a sales representatives misleading presentation on the safety of ...

Class 2 for Herpes Virus Lesion Panel IVD

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Federal Register notice: FDA classifies the herpes virus nucleic acid-based cutaneous and mucocutaneous lesion panel into Class 2 ...

Regulatory Review Period Determined for Tremfya

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Federal Register notice: FDA determines the patent extension-related regulatory review period for Janssen Biotechs Tremfya (guselk...

Gil Debarred for 6 Years Over Healthcare Fraud

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Federal Register notice: FDA debars Isachi Gil for six years from providing services in any capacity to a person that has an appro...

FDA Proposes 2 Drug Communication Studies

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FDA solicits comments on two proposed CDER Office of Prescription Drug Promotion research projects.

FDA Looks to Technology Advances to Help Product Labeling

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FDA chief of staff Lauren Silvis says the agency is evolving to keep pace with technology advances, and one area it wants to focus...