Live from SQA Annual Meeting

April 21, 2009

Day one of the annual meeting of the Society for Quality Assurance (SQA) proved interesting. Attendees knowledgeable about the current situation at FDA say that Acting Commissioner Joshua Sharfstein requested a short email from all FDA employees on current problems inside the Agency. I’m sure he received an earful as many current and former FDAers are dissatisfied with the Agency’s level of protection for safe food, drugs, and medical devices.

An interesting session on international issues highlighted the FDA Final Rule, 21 CFR.120, on foreign trials not conducted under FDA’s regulations. This is an issue well discussed elsewhere on this blog. There was also discussion on the requirements of the British regulatory agency, MHRA. They are sometimes much stricter than FDA and MHRA conducts inspections in the United States of U.S. companies conducting clinical trials in the U.K. There have been clinical trials suspended by MHRA if they do not meet their strict standards.

Finally, this is the 25th anniversary of the founding of SQA. The organization was founded in response to the Good Laboratory Practice regulations, 21 CFR Part 58. It started out as the “Quality Assurance Roundtable” in 1980 and for the first few years it was hotly debated whether to start a professional organization at first. SQA was then founded in 1984. Now it is a worldwide organization with chapters in the U.K., Canada, Korea, and even Nigeria! A lot of work in 25 years. I’ll provide another update before the conference ends on Thursday.

See the SQA link to the right under Blogroll. Also the Declaration of Helsinki under Important References and a Post. And finally, Enforcement of the GLPs.

Ex-Top Cop comments on food safety

April 8, 2009

Margaret Glavin, former Associate Commissioner of Regulator Affairs (ACRA), made this recent analysis to the food industry in her new capacity as an independent consultant. The Associate Commissioner of Regulatory Affairs is sometimes referred to as the “Top Cop” at FDA. I personally had left FDA before she began as the ACRA. However, it seems to me that she is shifting the blame for FDA’s enforcement failures. I have posted her comments under “Interesting Articles” on the right (Glavin Comments). My opinion is this is another reason to separate out Food from Health Products in a complete reorganization of FDA. The difference between a pepperoni pizza and radiolabeled monoclonal antibodies is….?

You can read additional posts on FDA Commentaries here:


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