Abbreviated New Drug Application (ANDA) Forms and Submission Requirements
This page is a resource for ANDA Forms and Submission Requirements
Generic Drug Development
News and Announcements updated
Science & Research
In collaboration with industry and the public, FDA creates an annual list of regulatory science initiatives on generic drugs.
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…
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
Fashion industry ‘nervous’ over potential Vietnam tariffs
Though the region isn’t as large of a sourcing hub as China, experts say duties on Vietnam would create headwinds…