Administrative Document(s) and Correspondence - accessdata - accessdata fda 2025

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(a) Filing an NDA. (1) Within 60 days after FDA receives an NDA, the Agency will determine whether the NDA may be filed. The filing of an NDA means that FDA has made a threshold determination that the NDA is sufficiently complete to permit a substantive review.
0:18 2:27 Safe does it work the way its supposed to do the benefits of this drug outweigh the risks. And onceMoreSafe does it work the way its supposed to do the benefits of this drug outweigh the risks. And once drugs are approved. The FDA monitors them for safety.
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.
General Controls are the basic authorities of the Medical Device Amendments that provide the FDA with the means of regulating devices to ensure their safety and effectiveness. General Controls apply to all three classes of medical devices; however, they are the only level of controls that apply to Class I devices.
To formally request approval to market a new drug in the United States, Sponsors must submit either a New Drug Application (NDA) or a Biologics License Application (BLA) to the FDA. As their names suggest, BLAs relate to biological products while NDAs generally pertain to traditional small molecule drugs.
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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.
Unlike general correspondence, controlled correspondence requires detailed information and is intended to facilitate the development process by addressing specific inquiries related to potential or actual Abbreviated New Drug Application (ANDA) submissions.

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