Wednesday, May 25, 2011

FDA issues draft guidance on financial disclosures for investigators and drugmakers

The FDA has just issued a draft guidance on financial conflicts of interest for clinical investigators and the drugmakers that enlist their assistance. The document is designed to revise a 10-year set of rules and address an issue that has grown increasingly contentious in recent years.  “During the intervening years, interest has grown in the public disclosure of industry financial arrangements with physicians,” the agency writes. The “FDA is striving to achieve a proper balance between transparency and the right to privacy of clinical investigators with respect to their financial arrangements as expressed in the agency’s protection of privacy regulation.”
If you have something to say, then you should submit a comment to the FDA.

Here is the FDA draft guidance:
FDA: Financial Disclosure by Clinical Investigators (Draft Guidance)

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