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 Drug Master Files (DMFs) Inactive Ingredient Database Elemental Impurities Expiration Dates - Questions and Answers Laboratory Methods (Drugs) 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 [email protected]