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SMG 2020 FDA STAFF MANUAL GUIDES, VOLUME III GENERAL ADMINISTRATION FDA OFFICIAL COUNCILS AND COMMITTEES FDA QUALITY SYSTEM FRAMEWORK FOR INTERNAL ACTIVITIES Effective Date: April 22, 2014 1. 2. 3.
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FDA official councils are advisory committees composed of external experts who provide independent advice to the FDA on a wide range of scientific, technical, and policy matters related to the agency's regulatory responsibilities.
No one is required to file FDA official councils. These councils are established by the FDA to seek expert advice and recommendations on specific issues.
There is no specific process for filling out FDA official councils as they are not forms to be filled. Instead, members of these councils are selected and appointed by the FDA based on their expertise and qualifications.
The purpose of FDA official councils is to provide objective and independent advice to the FDA to assist in its decision-making process, particularly in areas where the agency may lack internal expertise or require external perspectives.
There is no specific information to be reported on FDA official councils as they are not reporting documents. Instead, members of these councils are expected to provide their expert opinions and recommendations on relevant matters.
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