FDA Announces User Fees for Drugs, Devices, Biosimilars

The FDA Safety and Innovation Act (FDASIA) contains 140 pages of changes to the pharmaceutical industry, including a pronounced change to User Fees for Published Drugs and Biosimilar Products. These changes may have quite an impact on your strategic development plans, which addressing sooner rather than later can have a effect on your bottom line.  Contact PDG today to see how our industry leading regulatory consultants can help you plan and execute the best course of action for your company.