New Drug Application
New Drug Application (NDA) has been the basis for the control and regulation of new drug in the US for decades. NDA is a means through which the pharma sponsors formally propose to the FDA to approve a new drug for sale and marketing in the U.S. It contains the data gathered during the animal studies and human clinical trials of an Investigational New Drug (IND).
The objective of the NDA is to offer sufficient information to permit FDA reviewer to reach the following key decisions:
- Whether the drug is safe and effective in its proposed use(s), and whether the benefits of the drug outweigh the risks.
- Whether the drugs’ proposed labeling (package insert) is appropriate, and what it should contain.
- Whether the methods used in manufacturing the drug and the controls used to maintain the drug's quality are adequate to preserve the drug's identity, strength, quality, and purity.
The documentation required in an NDA provides the following information about the drug:
- what happened during the clinical tests
- what the ingredients of the drug are
- the results of the animal studies
- how the drug behaves in the body
- how it is manufactured, processed and packaged
Guidance Documents for NDAs
The guidance documents provide guidelines to the processing, content, and evaluation/approval of applications and also to the design, production, manufacturing, and testing of regulated products. Some of the guidance documents to help prepare NDA's are:
- Bioavailability and Bioequivalence Studies Submitted in NDAs or INDs — General Considerations
- Changes to an Approved NDA or ANDA
- Container Closure Systems for Packaging Human Drugs and Biologics
- Format and Content of the Microbiology Section of an Application
- Format and Content of the Clinical and Statistical Sections of an Application
- Summary for New Drug and Antibiotic Applications--Format and Content of the Summary for New Drug and Antibiotic Applications
- Formatting, Assembling and Submitting New Drug and Antibiotic Applications
- Guideline for 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
- Drug Master Files: Guidelines
- FDA IND, NDA, ANDA, or Drug Master File Binders
- PET Drug Applications - Content and Format for NDAs and ANDAs_2011
Code of Federal Regulations (CFR)
The Section 21 of the CFR contains all regulations pertaining to food and drugs. 21CFR Part 314 describes the format for applications for FDA approval to market a new drug or an antibiotic drug.
NDA Forms
- Form FDA-356h: Application to Market a New Drug, Biologic, or An Antibiotic Drug For Human Use
- Form FDA-3397: User Fee Cover Sheet
- Form FDA-3331: New Drug Application Field Report
Source:
www.fda.govRelated Training:
Webinar on Introduction to the FDA New Drug Approval ProcessSeminar on FDA Requirements for the Pharmaceutical Industry: Inspection, OTC Drugs, IND/NDA/ANDA, eCTD and GMP Requirements
Featured Products
This 3-hr virtual seminar on the FDA New Drug Approval Process will cover the NDA and ANDA review and approval process including a discussion of preparing NDAs and ANDAs, relevant meetings, timing, costs, approval requirements and other FDA regulatory requirements. The various existing regulatory approval pathways (the “full” NDA, the 505(b)(2) NDA and the ANDA) will be discussed.
This training provides an up-to-date understanding of regulatory requirements for the development and implementation of biomarkers in drug development programs, as well as highlights of the most recent FDA sources on general, imaging (Including PET) and pharmacogenomic biomarkers.
This FDA New Drug Approval process training will provide attendees with the knowledge and skills needed to develop a successful 505 (b)(2) program.
