New Drug Application (NDA) | FDA - U.S. Food and Drug Administration
WEBThe 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...
21 CFR Part 314 -- Applications for FDA Approval to Market a New Drug
WEBApplication, 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 Cosmetic Act and to 505(b)(2) applications.
21 CFR § 314.50 - Content and format of an NDA.
WEBA new drug product, upon approval, may be entitled to a period of marketing exclusivity under the provisions of § 314.108. If an applicant believes its drug product is entitled to a period of exclusivity, it must submit with the NDA prior to approval the following information: (1) A statement that the applicant is claiming exclusivity.
Types of Applications | FDA - U.S. Food and Drug Administration
WEBAn 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...
CFR - Code of Federal Regulations Title 21 - Food and Drug Administration
WEBMar 22, 2024 · Subpart B - Investigational New Drug Application (IND) Sec. 312.23 IND content and format. (a) A sponsor who intends to conduct a clinical investigation subject to this part shall submit an...
IND Applications for Clinical Treatment: Contents and Format
WEBContent current as of: An expanded access submission may be a new IND application or a Protocol Amendment to an existing IND application.
Initial IND Application | Clinical Center - cc.nih.gov
WEBThe Investigator-Initiated Investigational New Drug (IND) Applications website has all the information to get from start to finish with an application to the FDA. Introduction. The introduction should briefly describe the research plan submitted in this IND, including a discussion of the disease state to be assessed.
Investigational New Drugs or Biologics | Clinical Center
WEBAn Investigational New Drug Application (IND) is a request for authorization from the Food and Drug Administration (FDA) to administer an investigational drug or biological product to humans.
eCFR :: 21 CFR Part 312 -- Investigational New Drug Application
WEB(a) This part contains procedures and requirements governing the use of investigational new drugs, including procedures and requirements for the submission to, and review by, the Food and Drug Administration of investigational new drug applications (IND's).
New Drug Application (NDA): Back to the Basics - Reed Tech
WEBJul 23, 2021 · A required part of this section is “Contents of Application”. This is a checklist with 15 items that must be included with the application. There is also a requirement to include any Investigational New Drug Applications (INDs) and Drug Master Files (DMFs) that are references within this particular NDA.