Guidance for Industry Microsoft Word - 9749fnl Pandemic.doc Postmarketing Adverse Event Reporting fo

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Specifications	Guidance for Industry Microsoft Word - 9749fnl Pandemic.doc Postmarketing Adverse Event Reporting for Medical Products and Dietary Supplements During an Influenz\ a Pandemic Postmarketing Adverse Event Reporting for Medical Products and Dietary Supplements During an Influenz\ a Pandemic FDA/CDER/OMALLEYS
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Guidance for Industry Postmarketing Adverse Event Reporting for Medical Products and Dietary Supplements During an Influenza

Specifications	Guidance for Industry Microsoft Word - 9749fnl Pandemic.doc Postmarketing Adverse Event Reporting for Medical Products and Dietary Supplements During an Influenz\ a Pandemic Postmarketing Adverse Event Reporting for Medical Products and Dietary Supplements During an Influenz\ a Pandemic FDA/CDER/OMALLEYS
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Content	Guidance for Industry Postmarketing Adverse Event Reporting for Medical Products and Dietary Supplements During an Influenza Pandemic U.S. Department of Health and Human Services Food and Drug Administration Office of Counterterrorism and Emerging Threats (OCET) Center for Drug Evaluation and Research (CDER) Center for Biologics Evaluation and Research (CBER) Center for Devices and Radiological Health (CDRH) Center for Food Safety and Applied Nutrition (CFSAN) February 2012 Safety OMB Control Number 0910-0701 Expiration Date: 02/28/2015 See additional PRA statement in Section IV of this guidance
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Following Datasheets	UCM080778_1 (2 pages) UCM080788_1 (4 pages) UCM080796_1 (2 pages) UCM080814_1 (2 pages) UCM080839_1 (3 pages) UCM080858_1 (3 pages) UCM080872_1 (1 pages) ucm080879-1_1 (2 pages) UCM081561_1 (84 pages) UCM081575_1 (32 pages)
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