FDA's drug regulatory pathways, its development strategies and regulatory considerations

  • Iva Dhulia Isazi Pharma & Techno Consultancy
  • Himani Patel
  • Narendra Chauhan
  • Nidhi Pardeshi


People who are interested in drug development may be aware that New Drug Applications (NDA) and Abbreviated New Drug Applications (ANDA) are 2 of the FDA's regulatory pathways for how prescription drugs can be approved and ultimately reach the market. In basic terms, NDAs are for new drugs that have not yet been approved and ANDAs are for generic products.

NDA, also called 505 (b)(1), is the format that manufacturers use to bring a formal proposal to the FDA that a new drug should be approved and made available for use by patients in the United States. Under 505(b)(1), all investigations supporting safety and effectiveness, both clinical and nonclinical, are conducted by or on behalf of the sponsor. The other pathway is termed as abbreviated because preclinical and clinical trials are not required. The abbreviated approval pathways are described in section 505(j) and 505(b)(2) of the FD&C Act and known as ANDA and Hybrid applications respectively. Hatch-Waxman amendments in 1984 provided for a suitability petition that allows the application of ANDA for a drug product that differs from the RLD in its dosage form, route of administration, strength, or active ingredient (in a product with more than one active ingredient). The differences allowed for suitability petition and 505(b)(2) application are same but ANDA filed through suitability petition can contain only those differences that do not need clinical evidence for efficacy and safety. This article identifies considerations to help potential applicants determine the appropriate submission pathway, its development strategies to support approval under those pathways.

Keywords: FDA, New Drug Applications (NDA), Abbreviated New Drug Applications (ANDA), IND, Petitioned ANDA, 505(b)(2) application, RLD


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How to Cite
Dhulia, I., H. Patel, N. Chauhan, and N. Pardeshi. “FDA’s Drug Regulatory Pathways, Its Development Strategies and Regulatory Considerations”. International Journal of Drug Regulatory Affairs, Vol. 9, no. 2, June 2021, pp. 6-15, doi:10.22270/ijdra.v9i2.460.