Drugs

Generic Drug Development

The FDA aspires to continually improve its pre-application interactions with applicants. To facilitate these interactions and to keep stakeholders as informed as possible, the agency provides the following resources and guidance on developing generic drug products and preparing and submitting abbreviated new drug applications (ANDAs).

Please note: Summary tables, application forms, and other ANDA submission resources are available in ANDA Forms & Submission Requirements.

  • Product-Specific Guidances for Generic Drug Development
    To facilitate generic drug product availability and to assist the generic pharmaceutical industry with identifying the most appropriate methodology for developing drugs and generating evidence needed to support ANDA approval, FDA regularly publishes product-specific guidances describing the Agency’s current thinking and expectations on how to develop therapeutic equivalents to specific reference listed drugs. 
  • Generic Drug Approvals
    FDA regularly updates a listing of first generic drug approvals. To view all generic drug approvals and tentative approvals, use the “Drug Approval Reports by Month” feature on Drugs@FDA and select “Original Abbreviated New Drug Approvals (ANDAs) by Month” for generic drug approvals or “Tentative Approvals by Month” for tentative approvals. The database is updated daily.  
  • Pre-ANDA Program
    The Pre-ANDA Program is a valuable information resource for generic drug applicants. The program features product development assistance and pre-submission and mid-review cycle meetings to help clarify regulatory expectations early in product development and during application review.
  • List of Off-Patent, Off-Exclusivity Drugs without an Approved Generic
    This list includes approved new drug applications (NDA) drug products that are no longer protected by patents or exclusivities, and for which the FDA has not approved an ANDA referencing that NDA product. The FDA maintains this list to improve transparency and encourage the development and submission of ANDAs in markets with little competition. The list is updated semiannually, and available in both PDF and Excel format. 
  • Authorized Generic Drugs
    The FDA List of Authorized Generic Drugs, updated quarterly, includes the drug trade name, the brand company manufacturer, and the date the authorized generic drug entered the market.  
  • Quality by Design (QbD)
    QbD is a scientific, risk-based, proactive approach to pharmaceutical development, incorporating deliberate design effort and appreciating how processes impact product performance. FDA has published two QbD report examples:
  • Inactive Ingredient Database
    The Inactive Ingredient Database provides information on inactive ingredients present in FDA-approved drug products, and can be used as an aid in developing generic drug products.
  • FDA Letters to Industry
    This series of letters informs generic drug product manufacturers of policy and procedure developments with respect to the Drug Price Competition and Patent Term Restoration Act of 1984.
  • Bioequivalence Study Retention Samples
    The FDA provides requirements for retaining samples of drug products used in bioavailability and bioequivalence testing. Regulations state that applicants shall retain reserve samples of the tested products administered to study subjects and release these samples to FDA upon request.
  • Educational Resources
    The FDA Center for Drug Evaluation and Research Small Business & Industry Assistance program offers a variety of multimedia learning resources. The CDER SBIA Learn web page has many helpful courses and recordings in the “Generic Drugs” section.

Generic Drug Regulatory Resources

Contact FDA

Potential applicants are encouraged to contact the FDA Generic Drugs Program with questions at any point in their development and ANDA preparation processes.

If you have specific questions regarding the development of a generic drug product not yet submitted in an abbreviated new drug application (ANDA), please submit a controlled correspondence by email to genericdrugs@fda.hhs.gov.

If you have a general question about generic drugs, please email druginfo@fda.hhs.gov.

If you have a question regarding an ANDA for which you are the applicant or authorized representative, please contact the regulatory project manager assigned to the application.

Office of Generic Drugs
10903 New Hampshire Avenue
Silver Spring, MD 20993
240-402-7920
301-595-1147 Fax

 

 

Page Last Updated: 12/15/2017
Note: If you need help accessing information in different file formats, see Instructions for Downloading Viewers and Players.
Language Assistance Available: Español | 繁體中文 | Tiếng Việt | 한국어 | Tagalog | Русский | العربية | Kreyòl Ayisyen | Français | Polski | Português | Italiano | Deutsch | 日本語 | فارسی | English