Summary Company Announcement Date: March 01, 2023 FDA Publish Date: March 02, 2023 Product Type: Drugs Reason for Announcement: Recall Reason Description Potential lack of sterility. […]

Image By: Patrizia Cavazzoni, MD, Director, Center for Drug Evaluation and Research The U.S. Food and Drug Administration regulates biological products, or biologics, which have transformed […]

Image By: Susan M. Rosencrance, Ph.D., Acting Director, Office of Generic Drugs, Center for Drug Evaluation and Research Generic drugs account for approximately 91% of prescriptions […]

In 2022, generic drugs remained a significant public health priority for the FDA. Competition from generic drug makers helped make drugs more widely available and generally […]

[embedded content] Español 简体中文   한국어   Tagalog   Việt While we remain vigilant to protect our families and communities from the spread of COVID-19, some […]

Submit Comments by 05/01/2023 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 […]

Action FDA has approved Skyclarys (omaveloxolone) as the first treatment for Friedreich’s ataxia, a rare, inherited, degenerative disease that damages the nervous system, characterized by impaired […]

Section 409I of the Public Health Service Act, which was created by the Best Pharmaceuticals for Children Act (BPCA), requires the National Institutes of Health (NIH), […]

To promote shared learning and understanding with external stakeholders, FDA continues to oversee and support numerous demonstration (i.e., research) projects on Digital Health Technologies (DHTs) through […]