Brands International Corporation – 06/21/2024

Explore the FDA’s Competitive Generic Therapy Approvals page, offering insights into the program designed to encourage generic drug competition. Access information about approved CGT products and find resources, including a downloadable CGT approvals spreadsheet.

Sato Pharmaceutical Co., Ltd. – 11/21/2025. Country: Japan. Record Type: 483

Information and resources for requestors about FDA’s Biomarker Qualification Program

Unlawful Sale of Unapproved and Misbranded Drugs to United States Consumers Over the Internet

Regulatory Education for Industry (REdI) Annual Conference 2024: Innovation in Medical Product Development

As defined by FDA, real-world data (RWD) are the data relating to patient health status and/or the delivery of health care routinely collected from a variety of sources and real-world evidence (RWE) is the clinical evidence regarding a medical product’s use and potential benefits or risks derived fr