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Waxman Questions FDAs Legal Priorities Favoring Industry

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House Government Reform and Oversight committee chair Henry Waxman seeks answers from FDA after an internal e-mail suggests that p...

Risk Info Not in Panhematin Letters

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CBERs Office of Compliance and Biologics Quality says Ovation Pharmaceuticals healthcare provider letters on Panhematin dont give ...

FDA Places Import Alert on 2 Ranbaxy Plants

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FDA warns Ranbaxy Laboratories over cGMP problems at two facilities in India and issues an Import Alert for more than 30 generic d...

Info on Postmarketing Adverse Events to OMB

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Federal Register Notice: FDA sends to OMB a proposed collection of information on postmarketing adverse event reporting for nonpre...

Info on AERs for Supplements Sent to OMB

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Federal Register Notice: FDA sends to OMB a proposed collection of information on adverse event reporting and recordkeeping for di...

FY 2009 Animal Drug User Fees Posted

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Federal Register Notice: FDA announces the animal drug user fee rates for fiscal year 2009.

Generic Animal Drug User Fees Set

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Federal Register Notice: FDA announces the rates and payment procedures for FY 2009 generic new animal drug user fees.

Panels to Discuss Influenza Antiviral MedKit

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Federal Register Notice: FDAs Antiviral Drugs Advisory Committee and the Nonprescription Drugs Advisory Committee will meet 10/29 ...

ICH Prep Meeting Set

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Federal Register Notice: FDA plans a public meeting for the preparation for the November ICH meetings in Brussels, Belgium.

CGMP Violations at Concept Laboratories

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A Chicago District Office Warning Letter says cGMP violations were found at Concept Laboratories, which also is manufacturing and ...