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  1. Drug and Biologic Approval and IND Activity Reports

IND Receipts

IND Receipts

IND Receipts represent a count of new INDs received during the calendar year.

The “CDER Original INDs Received 1986-2008” report is no longer being updated and is archived here. Beginning in 2009, IND receipt information is being presented in the following two reports: 1) “CDER Drug and Non-Biosimilar Biologic IND Receipts” and 2) “CDER Biosimilar Biologic IND Receipts”. New reports will be published annually.

The Patient Protection and Affordable Care Act (ACA), signed into law by President Obama on March 23, 2010, amended the Public Health Service Act (PHS Act) to create an abbreviated licensure pathway for biological products that are demonstrated to be “biosimilar” to or “interchangeable” with an FDA-licensed biological product. This pathway is provided in the part of the law known as the Biologics Price Competition and Innovation Act (BPCI Act) of 2009. As a result, a separate report was created to capture information on biosimilar biologic INDs.