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New Drug Application (NDA) is a type of application in which a pharmaceutical manufacturer or its agent requests permission from the U.S. Food and Drug Administration (FDA) for a license to market a drug for one or more specified indications.
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.
The Food and Drug Administration (FDA) is responsible for protecting the public health by assuring the safety, efficacy, and security of human and veterinary drugs, biological products, medical devices, our nations food supply, cosmetics, and products that emit radiation.
The Information Disclosure Portal is designed to improve non-public information sharing across FDA stakeholders that will support collaboration amongst federal, state, local, territorial, and tribal partners.
Contact FDA Call: 1-888-INFO-FDA. (1-888-463-6332) Email: See Contact FDA Centers and Offices below or search the employee directory. Write to: Food and Drug Administration. 10903 New Hampshire Ave. Silver Spring, MD 20993-0002.
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People also ask

The FDAs regulations on COI disclosure require that all individuals involved in the development, evaluation, or approval of a food product must disclose any financial or other interests that could potentially influence their decision-making.
Why do some dietary supplements have wording on the label that says: This statement has not been evaluated by the Food and Drug Administration. This product is not intended to diagnose, treat, cure, or prevent any disease? This statement, known as a disclaimer, is required by law (21 U.S.C.

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