Newsletter - October 6, 2016
Most Ex-FDA Reviewers Work for the Regulated Industry and That’s A Good Thing
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 reviewers are one of the best trained regulatory subject-matter experts in the World. Read More
Is FDA “Over-Regulating” Some Low-Risk Products?
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). In May of this year, FDA added electronic cigarettes to the list of tobacco products even when the nicotine used in such products was not of tobacco-origin. Read More..
Most Ex-FDA Reviewers Work for the Regulated Industry and That’s A Good Thing
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 reviewers are one of the best trained regulatory subject-matter experts in the World. Read More
Is FDA “Over-Regulating” Some Low-Risk Products?
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). In May of this year, FDA added electronic cigarettes to the list of tobacco products even when the nicotine used in such products was not of tobacco-origin. Read More..
