Day: October 6, 2016

In recent years, FDA has reversed its policy of enforcement discretion for several products whereby certain products were regulated less due to lower perceived risk. Two of such cases have garnered wide-spread criticism. Late last year, FDA released several new guidance documents to create new stricter rules for Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps). … Read more

Not surprisingly, a report in BMJ last week said that most reviewers find jobs in the regulated industry after leaving FDA. The authors of the report raised conflict of interest concerns regarding the so-called “revolving door” between FDA and industry. However, a close review of the existing policies at FDA show that such concern is unfounded. FDA … Read more