tailieunhanh - Guidance for Clinical Investigators, Industry, and FDA Staff Financial Disclosure by Clinical Investigators

These statements reflect The Princeton Review's current views concerning future events, these forward-looking statements are subject to risks and uncertainties. The Princeton Review's actual results could differ materially from those anticipated in these forward-looking statements as a result of many factors, including, but not limited to, demand for the company's products and services; the company's ability to compete effectively and adjust to rapidly changing market dynamics; the timing of revenue recognition from significant contracts with schools and school districts; market acceptance of the company's newer products and services; continued federal and state focus on assessment and remediation in K-12 education;. | Guidance for Clinical Investigators Industry and FDA Staff Financial Disclosure by Clinical Investigators DRAFT GUIDANCE This guidance document is being distributed for comment purposes only. Comments and suggestions regarding this draft document should be submitted within 60 days of publication in the Federal Register of the notice announcing the availability of the draft guidance. Submit comments to the Division of Dockets Management HFA-305 Food and Drug Administration 5630 Fishers Lane rm. 1061 Rockville MD 20852. All comments should be identified with the docket number listed in the notice of availability that publishes in the Federal Register. For questions regarding this draft document contact Marsha Melvin Office of Good Clinical Practice at 301-796-3340 Leah Ripper Center for Drug Evaluation and Research at 301-7961282 Sheila Brown Center for Devices and Radiological Health at 301-796-6563 and Office of Communication Outreach and Development Center for Biologics Evaluation and Research at 800-835-4709 or 301-827-1800. . Department of Health and Human Services Food and Drug Administration Office of Good Clinical Practice Center for Drug Evaluation and Research Center for Biologics Evaluation and Research Center for Devices and Radiological Health May 2011 Contains Nonbinding Recommendations Draft Not for Implementation Guidance for Clinical Investigators Industry and FDA Staff Financial Disclosure by Clinical Investigators Additional copies are available from Office of Communication Division of Drug Information Building 51 Room 2201 Center for Drug Evaluation and Research Food and Drug Administration 10903 New Hampshire Avenue Bldg. 51 rm. 2201 Silver Spring MD 20993-0002 Tel 301-796-3400 Fax 301-847-8714 E-mail druginfo@ http Drugs GuidanceComplianceRegulatoryInformation Guidances and or Office of Communication Outreach and Development HFM-40 Center for Biologics Evaluation and Research Food and Drug Administration .