Regulatory Affairs Tag

What is FSMA? The FDA Food Safety Modernization Act (FSMA) was signed into law by President Barack Obama in 2011. This enables the Food and Drug Administration (FDA) to provide oversight, ensure compliance with requirements, and respond effectively to problems....

Posted by Stephanie Bouzounis, Senior Communications Specialist   Daily consumers use and consume products that have the potential to harm or enhance their health. Medications, food, and medical devices are all regulated by the Food and Drug Administration (FDA). Cosmetics, like these...

Spring conference season is upon us and EMMA International has just finished an exciting month of conferences with some incredible organizations we work closely with. If you are not familiar with the Medical Device Manufacturers Association (MDMA), the Manufacturers Association...

Since its creation in 2002, the Office of Combination Products (OCP) has been tasked with developing regulations and guidance documents for combination products [1]. A combination product is a product composed of any combination of drug/device, drug/biologic, biologic/device, or device/drug/biologic...