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U.S. Department of Health and Human Services

Drugs

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Resources for You

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.

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Reports

  • ANDA (Generic) Drug Approvals
  • IND Activity
    includes reports on new IND receipts; existing IND activity; INDs put on clinical hold; fast track designations; expanded access; rare diseases.
  • 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; rare diseases.
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