* Disclose all financial interests of all clinical investigators on the company's Web site
* Provide complete disclosure of financial interests to the FDA and conduct reasonable due diligence to insure that the disclosures are complete and accurate
* Disclose all financial interests directly to health care facilities serving as clinical trial sites
* Provide Financial Interest and Disclosure training to employees.
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The Synthes agreement pertains to all ongoing and future clinical trials, except for those conducted outside the U.S. and not intended for use in the marketing of products in this country.
In addition to the other settlement terms, Synthes will pay the state a total of $236,000 as reimbursement for fees and costs related to the investigation.
Also, Stryker Corporation has received a subpoena from the Attorney General of New Jersey and an FDA warning, concerning trials of its maxillofacial implant products, according to an SEC document. The document said other companies are also under investigation.
Read the settlement agreement:
http://www.nj.gov/oag/newsreleases09/pr20090505a-Synthes-avc-signed.PDF
Read New Jersey's letter to the FDA:
http://www.nj.gov/oag/newsreleases09/050509-FDA-letter.pdf
Sources: Office of the Attorney General, State of New Jersey; SEC
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