Zantac Lawsuit


Researching drug company and regulatory malfeasance for over 16 years
Humanist, humorist

Saturday, April 08, 2006

CLINICAL TRIAL AUTHORISATION

Founder member of the Online Seroxat Support Group (OSSG) Mr Derek Scott, has requested for the Informed Consent Document to be released under the Freedom of Information Act 2000.

To his suprise he recieved a personal reply from Prof. Kent Woods, Chief Executive of the Medicines and Healthcare products Regulatory Agency (MHRA) which is below for you to peruse.

Dear Mr Scott

Approval of the Informed Consent document does not form part of the clinical trial authorisation process performed by the MHRA under the legislation. That is the task of a Research Ethics Committee, to which the research sponsors make a separate application.

Regards
Kent Woods
CEO


Mr Derek Scott is now liasing with the Research Ethics Committee to see if what Prof. Kent Woods is indeed true.

My own MP, Gisela Stuart, is now trying to contact The Health Select Committee on my behalf. I have previously sent out emails to every single member of The Health Select Committee - not one of them has had the decency to even acknowledge receipt of my emails.

More about the Research Ethics Committee soon.

Bob Fiddaman (Group Moderator of the Online Seroxat Support Group)

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