The Federal Food, Drug, and Cosmetic Act (the FD&C Act), as amended by the Biosimilar User Fee Amendments of 2022 (BsUFA III), authorizes FDA to assess […]

The Federal Food, Drug, and Cosmetic Act (the FD&C Act), as amended by the Biosimilar User Fee Amendments of 2022 (BsUFA III), authorizes FDA to assess […]

Background The Fit-for-Purpose (FFP) Initiative provides a pathway for regulatory acceptance of dynamic tools for use in drug development programs. Due to the evolving nature of […]

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

For Immediate Release: January 10, 2025 Today, the U.S. Food and Drug Administration is providing an at-a-glance summary of news from around the agency: Today the […]

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 […]