BsUFA II: Assessment of the Program for Enhanced Review Transparency and Communication in the Biosimilar User Fee Act

[FDA]

Over the years, FDA has worked to increase communication between Agency staff and applicants during the review of novel drug and original biologic applications. The goal has been to enhance the transparency, predictability, effectiveness, and efficiency of the review process.


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