Image Creating a Yearly Snapshot for Approvals CDER began publishing the annual New Drug Therapy Approvals report in 2011 to highlight that year’s approvals with active […]

Submit Comments by 04/08/2025 Although you can comment on any guidance at any time (see 21 CFR 10.115(g)(5)), to ensure that the FDA considers your comment […]

FRAME Efforts Advanced manufacturing technologies have the potential to improve the reliability and robustness of the manufacturing process and supply chain and increase timely access to […]

Image The U.S. Food and Drug Administration’s Oncology Center of Excellence created Project Connect to give patients, survivors, and advocates a place to connect with each […]

HOW TO USE THIS SNAPSHOT The information provided in Snapshots highlights who participated in the key clinical trials that supported the original FDA approval of this […]

The Center for Drug Evaluation and Research (CDER) has a mission to ensure the availability of safe and effective medicines to improve the health of people […]

Every technology begins with an idea – how to make something better or create something brand new. The Emerging Technology Program – or ETP – at […]

The National Environmental Policy Act of 1969 (NEPA) requires all Federal agencies to assess the environmental impact of their actions and to ensure that the interested […]

FDA published the final report of its join pilot program with the European Medicines Agency (EMA) for the parallel assessment of sections of applications relevant to […]