Zdrowie i gospodarka · 13/03/2015
US FDA Updates Guidelines for Abbreviated New Drug Applications and 505(b)(2) Applications
The US FDA has announced new guidelines for Abbreviated New Drug Applications (ANDAs) and 505(b)(2) Applications, which are used to review generic drug submissions. The updated regulations aim to streamline the review process and reduce the time required for FDA approval.
Source: Federal Register — Food and Drug AdministrationOpen original release →