Learning and Education to ADvance and Empower Rare Disease Drug Developers (LEADER 3D)
As part of the Accelerating Rare disease Cures (ARC) Program, CDER’s Rare Diseases Team inaugurated the Learning and Education to…
Dr. Reddy’s Issues a Nationwide Recall of Levetiracetam in 0.75% Sodium Chloride Injection 1,000 mg/100 mL, in the U.S., Due to Mislabeling of Infusion Bag
Dr. Reddy’s Laboratories Ltd is recalling one Batch/Lot No: A1540076 of Levetiracetam in 0.75% Sodium Chloride Injection, 1,000 mg/100 mL…
Science & Research
In collaboration with industry and the public, FDA creates an annual list of regulatory science initiatives on generic drugs.
Generic Drug Development
News and Announcements updated
Abbreviated New Drug Application (ANDA) Forms and Submission Requirements
This page is a resource for ANDA Forms and Submission Requirements
CDER Scientific Review Documents Supporting Emergency Use Authorizations for Drug and Biological Therapeutic Products | COVID-19
CDER Scientific Reviews Supporting EUA for Therapeutic Products
Drug Shortages
Drug Shortages Homepage
Jack Daniel’s maker says Canada pulling stock worse than tariffs
Brown-Forman’s CEO worries the response to U.S. duties by retailers could spread to Europe.
Project Orbis
Information Project Orbis, an initiative of the FDA Oncology Center of Excellence (OCE) that provides a framework for concurrent submission…
Upcoming EL-PFDD Meetings
Upcoming EL-PFDD Meetings