New Drug Application
The New Drug Application (NDA) is the vehicle used by drug sponsors to formally propose the FDA approval of a new pharmaceutical drug for sale and marketing in the United States. For several decades, every new drug on the U.S. market has been the subject of an approved NDA. Data gathered through animal studies and human clinical trials (for an Investigational New Drug) become part of the NDA.[1]
GOALS OF THE NDA
The NDA should provide sufficient information for the FDA reviewer to determine:
- Whether a drug is safe and effective, relative to its proposed use, and whether drug benefits outweigh any risks.
- Whether the drug’s proposed labeling/package insert is appropriate, and what information that insert should contain.
- Whether the manufacturing methods to make the drug and the controls used for quality assurance purposes are adequate for maintaining the drug’s identity, strength, quality, and purity.
PERTINENT INFORMATION
The documentation for an NDA is intended to tell the story of the drug’s development, from beginning to end. Information required by the FDA may include:
- What happened during clinical tests and trials
- List of drug ingredients
- Results of animal studies
- Information about how the drug behaves in the body
- How the drug is manufactured
- How the drug is processed
- How the drug is packaged
GUIDANCE DOCUMENTS, LAWS, AND REGULATIONS
There are a number of documents that may be helpful to those looking to prepare and submit an NDA. Applicable laws and regulations include:
- The Federal Food, Drug, and Cosmetic Act
- 21CFR Part 314: Applications for FDA Approval to Market a New Drug or an Antibiotic Drug (encompassed within Section 21 of the Code of Federal Regulations)
- Prescription Drug User Fee Act (PDUFA) – This legislation authorizes the FDA to collect three types of user fees from applicants who submit certain new drug and biological product applications.
The list below includes additional guidance documents that may be useful in the preparation of an NDA:
- Bioavailability and Bioequivalence Studies Submitted in NDAs or INDs – General Considerations (2014)
- PET Drug Applications – Content and Format for NDAs and ANDAs (2011)
- Changes to an Approved NDA or ANDA (2004)
- Changes to an Approved NDA or ANDA: Questions and Answers (2001)
- NDAs: Impurities in Drug Substances (2000)
- Container Closure Systems for Packaging Human Drugs and Biologics (1999)
- Format and Content of the Microbiology Section of an Application (1990)
- Drug Master Files: Guidelines (1989)
- Format and Content of the Clinical and Statistical Sections of an Application (1988)
- Summary for New Drug and Antibiotic Applications—Format and Content of the Summary for New Drug and Antibiotic Applications (1987)
- Formatting, Assembling and Submitting New Drug and Antibiotic Applications (1987)
- Guideline for Submitting Supporting Documentation in Drug Applications for the Manufacture of Drug Products
- Format and Content of the Human Pharmacokinetics and Bioavailability Section of an Application (1987)
- Format and Content of the Nonclinical Pharmacology/Toxicology Section of an Application (1987)
- FDA IND, NDA, ANDA, or Drug Master File Binders
NDA REVIEW PROCESS
The following graphic provides insight into the NDA review process
Source: CDER, 2014[2]
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