New Drug Application (NDA) is the source in the United States by which drug sponsors formally propose that the Food and Drug Administration (FDA) approve a new pharmaceutical for sale and marketing.

Guidance Documents for NDAs

Bioavailability and Bioequivalence Studies for Orally Administered Drug Products - General Considerations
Changes to an Approved NDA or ANDA
Container Closure Systems for Packaging Human Drugs and Biologics
Format and Content of the Chemistry, Manufacturing and Controls Section of an Application
Format and Content of the Microbiology Section of an Application.
Format and Content of the Clinical and Statistical Sections of an Application
Format and Content of the Summary for New Drug and Antibiotic Applications
Formatting, Assembling and Submitting New Drug and Antibiotic Applications. Submitting Supporting Documentation in Drug Applications for the Manufacture of Drug Substances.
Submitting Documentation for the Stability of Human Drugs and Biologics.
Submitting Samples and Analytical Data for Methods Validation.
Submitting Supporting Documentation in Drug Applications for the Manufacture of Drug Products.
NDAs: Impurities in Drug Substances
Format and Content of the Human Pharmacokinetics and Bioavailability Section of an Application.
Format and Content of the Nonclinical Pharmacology/Toxicology Section of an Application.
Providing Clinical Evidence of Effectiveness for Human Drug and Biological Products
Drug Master Files
Required Specifications for FDA's IND, NDA, and ANDA Drug Master File Binders
Qualifying for Pediatric Exclusivity
PET Drug Applications - Content and Format for NDAs and ANDAs
Refusal to File

Laws, Regulations, Policies and Procedures

The Federal Food, Drug, and Cosmetic Act
Code Of Federal Regulations (CFR)
21CFR Part 314

Advisory Committees

FDA Advisory Committees
CDER Advisory Committees
CFR 21 Part 14 Public Hearing Before a Public Advisory Committee
Guidance for Industry: Advisory Committees
FDA Meeting Transcripts 1995 to Present