Novel Drug Approvals for 2022
Innovative drugs often mean new treatment options for patients and advances in health care for the American public.
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…
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
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
Identification of Acetyl, Propionyl, and Butanoyl Derivatives of THC and Its Analogs, and Their Synthetic By‐Products in Oils and a Herbal Product
Eleven THC analogs were detected from oil and herbal products. ABSTRACT Since 2021, products claiming to contain Δ9-tetrahydrocannabinol (Δ9-THC) analogs…