The FDA Office of Generic Drugs follows a rigorous review process to make sure that, compared to the brand-name (or innovator) medications, the proposed generic medications: […]

For Immediate Release: April 09, 2024 Today, the U.S. Food and Drug Administration is providing an at-a-glance summary of news from around the agency:  On Friday, […]

Biosimilars Basics for Patients Approval, labeling, side effects, and safety Using Fat-Dissolving Injections That Are Not FDA Approved Can Be Harmful Buying & Using Medicine Safely […]

Notice to Industry: Bioresearch Monitoring Information System (BMIS) Data In order to foster transparency and encourage information sharing within the clinical research community, FDA’s Center for […]

Summary Company Announcement Date: July 20, 2020 FDA Publish Date: July 20, 2020 Product Type: Drugs Reason for Announcement: Recall Reason Description Potential Methanol Contamination Company […]

Summary Company Announcement Date: June 28, 2022 FDA Publish Date: June 29, 2022 Product Type: Drugs Reason for Announcement: Recall Reason Description Incorrect labeling Company Name: […]

The Biologics Track will focus on the developmental and regulatory topics relevant to cellular and gene therapies, tissue-engineered products, blood products, vaccines, and other biological products. […]

The devices track will provide an overview and highlights of how to get a new medical device to market, discuss some best practices for ensuring that […]

The drugs track will address major advances and innovation across various aspects of the drug development spectrum. Content will provide updates and cutting-edge insight on novel […]