Beginning in 2009, INDs with Activity represent a distinct count of new INDs received during the calendar year and previously received INDs which had an incoming document during the same period. Prior to 2009, this report captured INDs with an “active” status in our database at the end of the calendar year.
The “CDER Number of Active INDs 1986-2008” report is no longer being updated and is archived here. Beginning in 2009, IND activity information is being presented in the following two reports: 1) “CDER Drug and Non-Biosimilar Biologic INDs with Activity” and 2) “CDER Biosimilar Biologic INDs with Activity”. 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.