Request for OMB Review Supporting Document Health and Diet - fda 2025

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Guidance documents describe FDAs interpretation of or policy on a regulatory issue (21 CFR 10.115(b)). In general, FDAs guidance documents do not establish legally enforceable responsibilities and thus are not binding on FDA or the public.
Please direct concerns to the appropriate FDA center by visiting our SmartHub webpage, which will guide you to the appropriate webform or phone number. If you are not able to use the SmartHub, you may also call 1-888-INFO-FDA and follow the prompts to report a problem.
An IR letter is a letter sent to an applicant during an application review to request further information or clarification that is needed or would be helpful to allow completion of the discipline review.
How to submit to the FDA Mail to CDER (Currently not being accepted by CDER): Mail application in triplicates (one original and two copies) or an e-copy (CD, flash drive, etc.) Submit through CDER NextGen Portal. FDA Electronic Submissions Gateway (please see below on instructions how to use)
All Annual Reports for changes to an approved application are submitted to CBER through CBERs Document Control Center (DCC) or electronically through the Food and Drug Administrations (FDA) Electronic Submission Gateway (ESG).
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People also ask

If you need information or if you have questions or comments about a medical product, please call the FDAs toll-free information line, 1-888-INFO-FDA (1-888-463-6332) Press 2 to report into MedWatch or for instructions.
What documents should I provide to FDA? You should provide FDA with entry documentation which may include the following: Bill of Lading (BOL), Airway Bill (AWB), invoice, and purchase order.
Labeling for drugs approved after 1998 may often be found at Drugs@FDA. Another option for finding additional information on a drugs side effects is to request this through the FDAs Freedom of information Office (FOI).

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