10.21.2020

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.
10.21.2020

Recently Issued Guidance Documents

This page lists Recently Issued CBER and Cross-Center Guidance Documents.
10.21.2020

GDUFA III

GDUFA III page
10.21.2020

GDUFA III Minutes

GDUFA III Minutes
10.21.2020

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.
10.21.2020

How Do Allocations Work for the Pharma Supply Chain?

How Do Allocations Work for the Pharma Supply Chain? ahyler Wed, 10/21/2020 - 14:11
10.21.2020

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.
10.21.2020

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.
10.21.2020

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.
10.21.2020

Novartis taps celeb dancer and 'Ellen' show DJ to headline Adakveo social challenge

Novartis taps celeb dancer and 'Ellen' show DJ to headline Adakveo social challenge bbulik Wed, 10/21/2020 - 12:43