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…
Quantitative Investigation of Nitrosamine Drug Substance‐Related Impurities (NDSRIs) Under Artificial Gastric Conditions by Liquid Chromatography–Tandem Mass Spectrometry and Structure–Activity Relationship Analysis
The study provides information about the impact of physiological gastric conditions on the unbeneficial occurrence of nitrosamine drug substance–related impurities…
In Vivo Metabolic Studies of 2‐Hydroxyethyl Salicylate in Horses
This article describes the studies of in vivo metabolism and elimination of 2-hydroxyethyl salicylate (2HES) in horse urine and plasma for…
Supporting Clinical Practice Guidelines for Drugs with Abuse Potential
Information regarding the FDA’s efforts to support the development of clinical practice guidelines for drugs with abuse potential.