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  1. Development & Approval Process (Drugs)

Drug and Biologic Approval and IND Activity Reports

Drug and Biologic Approval and IND Activity Reports

The list below includes links to Center for Drug Evaluation and Research new drug and biologic approval reports. These reports contain information on new drug application (NDA), biologic license application (BLA), and abbreviated new drug application (ANDA) approvals.

The list also includes a link to investigational new drug (IND) activity reports.

For Center for Biologic Evaluation and Research (CBER) BLA approvals, please visit: CBER Approvals by Year.

Reports

  • First Generic Approvals: FDA considers first generics to be important to public health, and prioritizes review of these submissions.
  • IND Activity: Includes reports on IND receipts; IND activity; breakthrough therapy designations; expanded access.
  • NDA and BLA Approvals: Includes reports on NDA and BLA approvals for: NMEs and new biologics; priority NDAs and BLAs; efficacy supplements; approval times; fast track; breakthrough therapy; accelerated approvals; animal rule approvals; and rare diseases.