NIDPOE: An FDA Warning Letter on Steroids


FDA Warning Letter

FDA Increases Warnings on Clinical Trials

It is more serious than an FDA Warning Letter. It doesn’t happen very often but for the fourth time this year FDA has issued a NIDPOE letter, Notice of Intitiation of Disqualification Proceedings and Providing Opportunity to Explain. This is only for the most serious breaches of FDA regulations by a clinical investigator. The most recent letter is to Dr. Daniel Berger of Chicago. The letter lists some very serious charges against Dr. Berger. The first one is:

“1. You repeatedly or deliberately submitted false information to the sponsor in a required report [21 CFR 312.70(a)].

Multiple documents contain falsified information. For example:

a. For Subject 010414, the following forms contained fraudulent signatures, which represented that the forms were signed by one of the sub-investigators: Northstar Healthcare form dated 7/29/08, Inclusion Criteria form dated 7/29/08, Exclusion Criteria form dated 7/29/08, Assessment of (b)(4) Illnesses/Events form dated 7/29/08, Medical/Surgical History form dated 7/29/08, Physical Examination form dated 7/29/08, and the report for the EKG performed on 7/29/08.”

The list goes on from there. There really isn’t much to say if the charges can be substantiated. The Blog is unaware of Dr. Berger’s respone, if any. When it does come it will probably come from his attorney.

http://www.fda.gov/RegulatoryInformation/FOI/ElectronicReadingRoom/ucm092185.htm

One Response to NIDPOE: An FDA Warning Letter on Steroids

  1. sid says:

    hey carl,
    thanks for that link, but it is dead…. it is hard to copy and paste it (need to include a couple of spaces after the url), but the url is dead or ‘removed’. One wonders if the attorney responded….

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