In 2020, CDER’s Office of Generic Drugs (OGD) and several partner researchers quantified the effect of drug solubility and partition coefficient on the dissolution and subsequent […]

Pharmacometric Models as Tools in Drug Development and Review Pharmacokinetic (PK) models are increasingly relied upon in drug development and review. Typically consisting of a set […]

CDER researchers and collaborators at NCTR are developing pharmacometric models that can support software tools that can be used by clinicians to guide drug dosing for […]

Over the past decade, progress has been made in planning and conducting clinical trials for rare disease drug development. In 2018, for the first time ever, […]

For Immediate Release: August 09, 2024 Today, the U.S. Food and Drug Administration is providing an at-a-glance summary of news from around the agency:  Today, the […]

Supporting the development and evaluation of new treatments for rare diseases is a key priority for the FDA. The FDA has authority to grant orphan drug […]

On This Page Date: October 16, 2024 Time: 10:00 AM – 1:00 PM ET Location: Event Location White Oak Campus: The Great RoomConference Center 10903 New […]

For Immediate Release: August 09, 2024 Today, the U.S. Food and Drug Administration approved neffy (epinephrine nasal spray) for the emergency treatment of allergic reactions (Type […]

1. Is it legal to import medicines into the U.S. from other countries? No. The United States Federal Food, Drug, and Cosmetic Act (The Act) prohibits […]