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Old July 5th, 2011
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Minuteman Minuteman is offline
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Default Interesting FDA disqualified clinical investigators proposed rule change

(Cross-posted at RF)

I just found this proposed rule on the regulations.gov site -

"Disqualification of a Clinical Investigator" [Docket No. FDA-2011-N-0079]
http://www.regulations.gov/#!documen...11-N-0079-0001

Basically, there are three categories of trials overseen by the FDA: human drug trials, animal drug trials, medical device trials. If a clinical investigator is disqualified by the Commissioner from conducting clinical trials, it is only for the category in which a breach of practice occurred. For example, an clinical investigator disqualified from conducting human drug trials can still conduct animal drug trials and medical device trials (an investigator disqualified by settlement with the FDA might be excluded from other categories by mutual agreement).

This proposed rule change would ensure that an investigator disqualified for conduct in one category are automatically disqualified in all three.

Would it be worth drafting a reply praising this proposed rule change, and high-lighting the failings of circumcision devices, in the hope of putting this issue on the FDA's radar?

I have written other posts regarding the FDA's warning letters to device importers/manufacturers (do tag searches of "fda" and "devices").

The deadline for public comments is 12 July 2011.
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Old May 1st, 2012
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Minuteman Minuteman is offline
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Default Re: Interesting FDA disqualified clinical investigators proposed rule change

"FDA Issues Final Rule on Clinical Investigator Disqualification" FDA mailing-list email dated 2 May 2012.

http://www.gpo.gov/fdsys/pkg/FR-2012...2012-10292.pdf

From the mailing-list email:

Quote:
You are receiving this message because you are a subscriber to the Good Clinical Practice/Human Subject Protection e-mail update service provided by the U.S. Food & Drug Administration (FDA).

FDA is amending the regulations to expand the scope of clinical investigator disqualification. Under this rulemaking, when the Commissioner of Food and Drugs determines that an investigator is ineligible to receive one kind of test article (drugs, devices or new animal drugs), the investigator also will be ineligible to conduct any clinical investigation that supports an application for a research or marketing permit for other kinds of products regulated by FDA. This final rule is based in part upon recommendations from the Government Accountability Office, and is intended to help ensure adequate protection of research subjects and the quality and integrity of data submitted to FDA. FDA also is amending the list of regulatory provisions under which an informal regulatory hearing is available by changing the scope of certain provisions and adding regulatory provisions that were inadvertently omitted. This rule is effective May 30, 2012.
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