generic drug research and development - StatementEssaydatesCom

generic drug research and development

  • Skip to main page content
  • Skip to search
  • Skip to topics menu
  • Skip to common links
HHS
U.S. Department of Health and Human Services

U.S. Food and Drug Administration

  • A to Z Index
  • Follow FDA
  • En Español

Drugs

    • Home
    • Drugs
    • Development & Approval Process (Drugs)
    • How Drugs are Developed and Approved
    • Types of Applications

    Generic Drug Development

    • Share
    • Tweet
    • Linkedin
    • Pin it
    • More sharing options

      • Linkedin
      • Pin it
    • Email
    • Print


    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 [email protected] 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:

      • Quality by Design (QbD): An Example Pharmaceutical Development Report for an Immediate Release (IR) Dosage Form , 2012 (PDF, 1.5MB)
      • Quality by Design (QbD): An Example Pharmaceutical Development Report for a Modified Release (MR) Dosage Form , 2011 (PDF, 2.2MB)
    • 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.
    • Hatch-Waxman Letters
      The FDA has posted certain letters reflecting FDA’s decisions on 180-day exclusivity and other matters related to generic drug approvals.
    • 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

    • Product-Specific Guidances for Generic Drug Development
    • Generic Drugs Guidances
    • Biopharmaceutics Guidances
    • Laws Enforced by the FDA
    • Generic Drug User Fee Amendments (GDUFA )
    • Code of Federal Regulations (CFR)
    • Federal Register (FR)
    • CDER FOIA Electronic Reading Room

    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 [email protected] .

    If you have a general question about generic drugs, please email [email protected] .

    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

    • Hatch-Waxman Letters

    More in Types of Applications

    Important Addresses for Regulatory Submissions

    Investigational New Drug (IND) Application

    Emergency Investigational New Drug (EIND) Applications for Antiviral Products
    IND Forms and Instructions
    Investigator-Initiated Investigational New Drug (IND) Applications
    Pre-IND Consultation Program

    Regulatory Information for INDs

    New Drug Application (NDA)
    Therapeutic Biologic Applications (BLA)

    Biosimilars

    Abbreviated New Drug Application (ANDA): Generics

    Generic Drug Development
    Abbreviated New Drug Application (ANDA) Forms and Submission Requirements
    Activities Report of the Generic Drugs Program (FY 2018) Monthly Performance
    Patent Certifications and Suitability Petitions
    Drug Applications for Over-the-Counter Drugs

    Resources for You

    • Generic Drugs
    • Industry Resources
    • [email protected]
    • Office of Generic Drugs
    • Abbreviated New Drug Application (ANDA)
    • Patent Certifications and Suitability Petitions
    • Paragraph IV Drug Product Applications: Generic Drug Patent Challenge Notifications

    Page Last Updated: 07/19/2018

    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