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 In this section:

        How Drugs are Developed and Approved

Drug and Biologic Approval and IND Activity Reports

                        
                


                IND Activity
          NDA and BLA Approvals
          First Generic Drug Approvals Home
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          Development & Approval Process | Drugs
          How Drugs are Developed and Approved
          Drug and Biologic Approval and IND Activity ReportsHow Drugs are Developed and Approved Drug and Biologic Approval and IND Activity Reports
  	
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    PrintThe 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.

                                                                                  Content current as of:
      10/17/2019Drug and Biologic Approval and IND Activity Reports                
                          

                        


                        IND Activity
          NDA and BLA Approvals
          First Generic Drug Approvals
 
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