Cell therapies are regulated as biologics under the Center for Biologics Evaluation and Research division of the FDA. All somatic cell therapies are regulated as biologics, however, some of the human cell therapy products are not considered biologics because of...
For the past few decades, the FDA has been attempting to increase the diversity of individuals participating in clinical trials. Specifically, they are trying to encourage any companies conducting clinical trials to include the demographics that will primarily be using...
Clinical Decision Support Software is a tool that is utilized in making decisions for the diagnosis, treatment, prevention, cure or mitigation of diseases and other critical conditions. Such a tool provides clinicians, health care staff or patients with intelligently filtered...
The U.S. Food and Drug Administration is offering another opportunity for stem cell clinics to work with the Agency and understand the regulatory framework. Will it work this time around? This blog article recaps how we got to this point. Stem...
The $40 billion dietary supplement industry is still growing making it a market you may want to take advantage of, but FDA’s oversight of these products is also increasing1. FDA currently regulates dietary supplements Under the Dietary Supplement Health and Education...
FDA has issued a proposed rule to up classify surgical staplers for internal use as class II medical devices, subject to special controls and pre-market notification. Currently, both internal and external surgical staplers are classified as class I, subject to...
Ensuring you have a robust Quality Management System (QMS) is the first step in maintaining compliance with both FDA and ISO regulations and requirements. A good software-based quality management system can make the process much easier. A paper-based or multi-software...
China is considered to be one of the many booming medical device markets with its continually increasing innovation potential and high market demand. In 2016, China’s medical device industry achieved a total sales revenue of 244.8 billion yuan, an increase...
FDA defines data integrity as the completeness, consistency, and accuracy of data. Data Integrity is not a new concept and it has been a matter of concern since the paper and ink era. With the new computerized systems and cloud...
On May 8, 2019, FDA released draft guidance, Clinical Lactation Studies: Considerations for Study Design, building upon the previous guidance, Clinical Lactation Studies – Study Design, Data Analysis, and Recommendations for Labeling, released in 2005. The draft guidance is expected...