FDA/CRCG Drug-Device Combination Products 101: Identifying, Developing, and Evaluating Drug-Device Combination Products - 05/10/2023

[FDA]

The purpose of this training is to describe FDA’s regulatory expectations and practices for pre-ANDA assessment and ANDA review of generic drug-device combination products, especially those with complex device constituent parts.


Baca selengkapnya di : http://www.fda.gov...