Zdrowie i gospodarka · 10/05/2019

FDA Announces Final Guidance on Abbreviated New Drug Application and 505(b)(2) Application

The US Food and Drug Administration (FDA) has released a final guidance document to help pharmaceutical companies decide which type of application to submit for a new drug, either an Abbreviated New Drug Application (ANDA) or a 505(b)(2) application, in order to obtain FDA approval for marketing purposes.