Newsletter - December 8, 2016
Will the New Law Boost Stem Cell Products and Other Regenerative Therapies?
Regenerative therapies are set to receive renewed attention and attractive regulatory incentives thanks to the 21st Century Cures Act (Cures Act) which is all but certain to become the law this week. The new law defines “regenerative medicine therapy” to be cell therapy, therapeutic tissue engineering products, human cell and tissue products, and combination products using any such therapies or products. Read More
Adverse Events for Food and Cosmetics
This week FDA released a comprehensive list of all adverse events (AEs) reported to it related to food, dietary supplements and cosmetics for the last 12 years. This information was previously available only upon freedom of information request. The announcement “Why FDA Is Making Data Extracted from Reports of Adverse Events for Foods and Cosmetics Available to the Public” sounds ironic once one reviews the list of AEs. Read More
Will the New Law Boost Stem Cell Products and Other Regenerative Therapies?
Regenerative therapies are set to receive renewed attention and attractive regulatory incentives thanks to the 21st Century Cures Act (Cures Act) which is all but certain to become the law this week. The new law defines “regenerative medicine therapy” to be cell therapy, therapeutic tissue engineering products, human cell and tissue products, and combination products using any such therapies or products. Read More
Adverse Events for Food and Cosmetics
This week FDA released a comprehensive list of all adverse events (AEs) reported to it related to food, dietary supplements and cosmetics for the last 12 years. This information was previously available only upon freedom of information request. The announcement “Why FDA Is Making Data Extracted from Reports of Adverse Events for Foods and Cosmetics Available to the Public” sounds ironic once one reviews the list of AEs. Read More