IBSPOT.com Inc. – 715657 – 10/27/2025

Fiscal Year 2025 Generic Drug Science and Research Initiatives Public Workshop

CDER Guidance Agenda

Since the passage of the Biosimilar User Fee Act (BsUFA) in 2012, user fees have played an important role in expediting the process for the review of biosimilar products.

Interstate Commerce/Food/Adulterated

The Laboratory Manual is a reference manual for FDA personnel. It provides FDA personnel with information on internal procedures to be used as an agency policy for testing consumer products, training of laboratory staff, report writing, safety, research, review of private laboratory reports and cour

CGMP/Finished Pharmaceuticals/Adulterated