Biomarker Qualification Submissions
The FDA CDER Biomarker Qualification Program invites submitters who have a biomarker qualification project accepted into the Program to voluntarily provide general information about their project and contact information to be posted on the FDA’s public web site. The table below lists submissions that are currently in the qualification process. Submissions listed here are only for those which submitters have agreed to make public. The table is updated on a quarterly basis and provides information on the biomarker qualification project and submitter contact information.
Recently Issued Guidance Documents
This page lists Recently Issued CBER and Cross-Center Guidance Documents.
GDUFA III page
GDUFA III Minutes
GDUFA III Minutes
Regulatory Pharmaceutical Fellowship
Information about the two-year post-graduate Regulatory Pharmaceutical Fellowship program. This program is jointly sponsored by academia, industry, and government, and offers specialized fellowships in the areas of Drug Information, Medication Safety, and Drug Advertising and Promotion. Information is available on how to apply.
How Do Allocations Work for the Pharma Supply Chain?
What's New Related to Drugs
Want to know what's new on drugs from FDA? This page provides quick links to the latest on a variety of topics including: drug approvals, safety warnings, drug shortages, etc.
Advisory Committees Give FDA Critical Advice and the Public a Voice
Not familiar with FDA’s advisory committees? These committees provide independent, expert advice to the FDA on a range of complex scientific, technical and policy issues related to the development and evaluation of FDA-regulated products.
Public Meeting on the Reauthorization of the Biosimilar User Fee Act (BsUFA) - 11/19/2020 - 11/19/2020
The Food and Drug Administration (FDA or Agency) is announcing a public meeting on the reauthorization of the Biosimilar User Fee Act (BsUFA) for fiscal years (FYs) 2023 through 2027.