New Drug Application (NDA) | FDA
The following resources have been gathered to provide you with the legal requirements of a new drug application, assistance from CDER to help you meet those requirements, and internal NDA review...
Types of Applications | FDA - U.S. Food and Drug Administration
An Abbreviated New Drug Application (ANDA) contains data that, when submitted to FDA's Center for Drug Evaluation and Research, Office of Generic Drugs, provides for the review and ultimate...
Guidance Documents for Drug Applications | FDA
Guidance Documents for Abbreviated New Drug Applications . The Abbreviated New Drug Application Process web page has an updated list of all guidances to help in the preparation of ANDA...
eCFR :: 21 CFR 314.50 -- Content and format of an NDA.
The NDA is required to contain reports of all investigations of the drug product sponsored by the applicant, and all other information about the drug pertinent to an evaluation of the NDA that is received or otherwise obtained by the applicant from any source.
21 CFR Part 314 -- Applications for FDA Approval to Market a New Drug
Application, new drug application, or NDA is the application described under § 314.50, including all amendments and supplements to the application. An NDA refers to “stand-alone” applications submitted under section 505(b)(1) of the Federal Food, Drug, and …
New Drug Application - Wikipedia
The Food and Drug Administration's (FDA) New Drug Application (NDA) is the vehicle in the United States through which drug sponsors formally propose that the FDA approve a new pharmaceutical for sale and marketing.
FDA Drug Approval: Application Review Times Largely Reflect …
2020年3月6日 · Before a drug can be marketed in the United States, FDA must determine that the drug is safe and effective for its intended use through a review of evidence that a drug sponsor—the entity seeking to market the drug—submits in an NDA.
FDA's 505(b)(2) Explained: A Guide to New Drug Applications - The FDA …
2024年7月17日 · Learn the basics of FDA's 505(b)(2) New Drug Application (NDA) pathway and how it provides a streamlined route for drug approval in the United States.
Purpose of an NDA •Enables FDA to determine: –Whether the drug is safe and effective for the proposed indication, and whether the drug’s benefits outweigh the risks –Whether the drug’s proposed labeling is appropriate, and what should be included in the package insert –Whether manufacturing methods & quality controls are
21 CFR 314.60 -- Amendments to an unapproved NDA, …
(a) Submission of NDA. FDA generally assumes that when an original NDA, supplement to an approved NDA, or resubmission of an NDA or supplement is submitted to the Agency for review, the applicant believes that the Agency can approve the …