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 […]

Summary Company Announcement Date: August 08, 2024 FDA Publish Date: August 08, 2024 Product Type: Drugs Reason for Announcement: Recall Reason Description Potential for particulate matter […]

The Division of Pediatrics and Maternal Health oversees quality initiatives which promote and necessitate the study of drug and biological products in the pediatric population and improve […]

FDA encourages interested parties who are considering the use of Digital Health Technologies (DHTs) in drug development or conducting decentralized clinical trials (DCTs) to engage the […]