Guidant Enters Agreement with U.S. Department of Health and Human Services; Corporate Integrity Agreement Strengthens Guidant's Commitment to Compliance.Business Editors/Health/Medical Writers INDIANAPOLIS, Ind IND Investigational new drug Therapeutics A status assigned by the FDA to a drug before allowing its use in humans, exempting it from premarketing approval requirements so that experimental clinical trials may be conducted. See Phase 1.2, 3 studies, Sponsorship. .--(BUSINESS WIRE)--July 1, 2003 Guidant Corporation (NYSE NYSE See: New York Stock Exchange :GDT GDT Global Descriptor Table GDT Geographic Data Technology Inc. GDT Gas Discharge Tube (energy, electrotechinical and electronics) GDT Getting Things Done GDT Geometric Dimensioning & Tolerancing GDT Ground Data Terminal ) today announced that it has entered into a corporate integrity agreement with the Office of the Inspector General Office of the Inspector General (or OIG) is a common sub-agency within cabinet-level agencies of the United States federal government and serves as auditing and investigative arm of the agency's programs focused on identifying waste, fraud and abuse. of the U.S. Department of Health and Human Services Noun 1. Department of Health and Human Services - the United States federal department that administers all federal programs dealing with health and welfare; created in 1979 Health and Human Services, HHS . The agreement is the final step in the resolution of the settlement between the company's EndoVascular Technologies, Inc. subsidiary and the U.S. Department of Justice, which was previously announced on June 12. Under the terms of the Corporate Integrity Agreement, Guidant will maintain a robust compliance program built around comprehensive policies, procedures and training. EndoVascular Technologies will focus its compliance activities on complaint handling and medical device reporting. The agreement is effective immediately. The agreement is consistent with Guidant's commitment to compliance and will serve to strengthen the company's existing compliance program. Compliance with this agreement will not impact the company's ability to obtain timely product approvals or to market products. |
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