Food and Drug Omnibus Reform Act (FDORA) of 2022

The Food and Drug Omnibus Reform Act of 2022 (FDORA) requires FDA to develop several different kinds of informational documents,…

Landy International – 679066 – 06/12/2024

CGMP/Finished Pharmaceuticals/Adulterated

Aqualex Co., Ltd. – 672292 – 06/12/2024

CGMP/Finished Pharmaceuticals/Unapproved New Drug/Adulterated

Angela D. Ritter, M.D. – 681999 – 06/07/2024

Clinical Investigator (Sponsor)

GFA Production Xiamen Co., Ltd. – 678364 – 06/13/2024

CGMP/Finished Pharmaceuticals/Adulterated

Center for Wellness and Integrative Medicine – 608693 – 06/30/2020

Unapproved and Misbranded Products Related to Coronavirus Disease 2019 (COVID-19)

Only Natural, Inc. dba Bio Nutrition, Inc. – 605076 – 06/18/2020

Unapproved New Drugs/Misbranded

FDA Roundup: March 21, 2025

The U.S. Food and Drug Administration is providing an at-a-glance summary of news from around the agency.

Antimicrobial Resistance

Antimicrobial resistance (AMR)—the ability of a microorganism (bacteria, virus, fungi, parasite) to resist the effects of a drug—is a serious,…