Resources
At Sage Submissions, we’re your resource for changes affecting how you do business, from submission requirements, changes to laws and regulations, and updated guidances.
FDA
FDA Innovation and Safety Act of 2012
- Statement from HHS Secretary on the signing of FDASIA S. 3817
- Biosimilar User Fee Act (BsUFA)
- Generic Drug User Fee Amendments of 2012 (GDUFA)
- Medical Device User Fee and Modernization Act (MDUFMA)
- Prescription Drug User Fee Act (PDUFA V)
Electronic Submission Guidances
- FDA Center for Drug Evaluation and Research (CDER) Electronic Regulatory Submission and Review
- FDA Center for Devices and Radiological Health (CDRH) Electronic Copies for Pre-Market Submissions
- FDA Center for Biologics Evaluation and Research (CBER)
- FDA Electronic Submission Gateway (ESG)
