FDA

No matter what scope your product falls under (medical device, drug, biologic, IVD) the regulatory requirements for your Quality Management System are strict. The FDA established its various Codes of Federal Regulations to enforce that a QMS is not just...

World Cancer Day, established by the Union for International Cancer Control (UICC) in 2000, is observed every year on February 4th. Over 10 million people die each year from cancer, more than HIV/AIDS, malaria, and tuberculosis combined.1 This makes cancer a...

February 3rd is celebrated as National Women Physicians Day. This day marks the birthday of Dr. Elizabeth Blackwell, the first woman to receive a medical degree in the United States in 1849. The day is celebrated in recognition of female...

A chronic disease that has affected many people in the US is Diabetes. Based on the 2020 statistical report from Diabetes Research Institute Foundation, the number of people suffering from Diabetes is 34.2 million people which is 10.5% of the...

The FDA’s process for drug development can be a lengthy, and often expensive, commitment. If you are developing a new drug product from the beginning, it is critical that you understand the phases of the development process and the deliverables...

The FDA’s Breakthrough Devices Program is for certain medical devices that provide treatment or diagnosis of life-threatening or irreversibly debilitating diseases or conditions.1 This particular pathway is reserved for devices with unique and other-wise unavailable treatments to serious conditions, but what...