![]() ![]() This pathway is provided in the part of the law known as the Biologics Price Competition and Innovation Act (BPCI Act) of 2009. 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. 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”. The “CDER Original INDs Received 1986-2008” report is no longer being updated and is archived here. The last step is to create a username and password.IND Receipts represent a count of new INDs received during the calendar year. Follow the on-screen prompts to complete registration.If you are, select “Yes.” Everybody else should select “No.” ![]()
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