Quality Information for Applicants | Chemistry, Manufacturing, and Controls (NDAs, ANDAs, BLAs, and IND applications)

The following resources should be helpful to applicants and manufacturers who are required to have an approved application before marketing or conducting a clinical trial. They provide information relevant to various application types. Much of the technical and scientific information will also be helpful for manufacturers of non-application drugs, such as over-the-counter (OTC) monograph products.

Types of Applications

Find detailed information about the following types of applications:

• Investigational New Drug Application regulations (IND) (21 CFR 312)
• Applications for FDA Approval to Market a New Drug (NDA) (21 CFR 314)
• Abbreviated New Drug Application (ANDA)
• Biologic License Application (BLA): General and Licensing (21 CFR 600 and 601)

 

Quality Related Guidances and Documents

• Visit FDA’s Search for Pharmaceutical Quality Documents
• FDA’s Search for FDA Guidance Documents page is also available to filter by
  • FDA Organization - Center for Drug Evaluation and Research
  • Topic
    • ICH-Quality
    • Chemistry, Manufacturing, and Controls (CMC)
    • Microbiology
    • Current Good Manufacturing Practice (CGMP)

Other Resources

• CGMP Regulations
• Developing and Manufacturing Drugs Including Biologics
• Drug Master Files (DMFs)
• Inactive Ingredient Database
• Elemental Impurities
• Expiration Dates - Questions and Answers
• Report a Product Quality Issue

The following resources provide additional details for specific types of applications:

• Questions and Answers on Quality-Related Controlled Correspondence
• Investigational New Drug (IND) Applications for Clinical Investigations: CMC Information
• Current Good Manufacturing Practices for Phase I Investigational Drugs
• Generic Drugs: Information for Industry
  • Generic Drug User Fee Amendments (GDUFA III) Implementation

Contact Information

CDER-OPQ-Inquiries@fda.hhs.gov