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A Letter of Authorization grants the Authorized Party (i.e. the IND Sponsor-Investigator) the right to incorporate the information contained within the DMF into their IND or other application by reference as opposed to direct disclosure.
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.
FDA is a regulatory agency responsible for promoting and protecting the public health by ensuring the safety of drugs. FDA administers the Federal Food, Drug, and Cosmetic Act and relevant sections of the Controlled Substances Act.
A controlled correspondence is a communication submitted to FDA by or on behalf of a generic drug manufacturer or related industry requesting information on a specific element of generic drug product development or certain postapproval submission requirements.
Most administrative correspondence is for the purpose of explaining something even though the communication frequently involves memos of direction, letters of gratitude, legislative interaction, peer communication, and so forth.
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Guidance documents do not establish any rights for any person and is not binding on FDA or the public.
Guidance documents represent FDAs current thinking on a topic. They do not create or confer any rights for or on any person and do not operate to bind FDA or the public. You can use an alternative approach if the approach satisfies the requirements of the applicable statutes and regulations.
The Food and Drug Administration is responsible for protecting the public health by ensuring the safety, efficacy, and security of human and veterinary drugs, biological products, and medical devices; and by ensuring the safety of our nations food supply, cosmetics, and products that emit radiation.

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