BARD ANNOUNCES RESOLUTION WITH FDA OF APPLICATIONS INTEGRITY POLICY FOR USCI DIVISION.MURRAY HILL, NJ--(BUSINESS WIRE)--June 30, 1995--C. R. Bard bard, in Wales, term originally used to refer to the order of minstrel-poets who composed and recited the poems that celebrated the feats of Celtic chieftains and warriors. The term bard in present-day usage has become synonymous with poet, particularly a revered poet., Inc. (NYSE-BCR) today announced that the FDA FDA - Food & Drug Administration (USA) FDA - Failure-Data Analysis FDA - Fatigue Damage Accumulation FDA - Fault Detection Accommodation FDA - Fault Detection and Accommodation FDA - Fault Detection and Annunciation FDA - Federal Disaster Area FDA - Final Delivered Article FDA - Final Drawing Approval FDA - Financial Disclosure Agreement FDA - First Division Association FDA - Flexor Digitorum Accessorius FDA - Flight Data Assistant has lifted the Applications Integrity Policy (AIP AIP - Abbreviated Implementation Plan AIP - Abbreviated Implementation Process AIP - Academic Integration Page AIP - Academic International Press AIP - Academic Internship Program (University of California, San Diego) AIP - Academic Intervention Program AIP - Accredited Incentive Practitioner AIP - Accumulated Income Payment AIP - Accuracy Improvement Program AIP - Acquisition Improvement Program AIP - Acquisition Intern Program) imposed on Bard's USCI USCI - United States Colored Infantry USCI - United States Computers, Incorporated USCI - University College Sedaya International division in January 1994. With this lifting, the FDA will now begin reviewing USCI's pre-market approval and 510(k) applications. The AIP was imposed on USCI following the plea agreement entered into by the company in October 1993 in connection with charges stemming from violations of the Federal Food, Drug and Cosmetic Act and other statutes. Under the AIP, all USCI pending product applications were audited by outside consultants hired by Bard and approved by the FDA. The company had to demonstrate to the FDA that it is capable of compiling and submitting product applications that are complete, based on sound science, and that fully document the safety and efficacy of its products. William H. Longfield, Bard's president and CEO, said, "USCI was the subject of a most rigorous, demanding audit process. This process has taught us a great deal, and Bard has made substantial improvements as a result. Achieving this crucial goal required internal teamwork, focused cooperation with the FDA and continued dedication to Bard's fundamental principles of `Quality, Integrity and Service'. From the start, Bard demonstrated its willingness to comply, its willingness to improve its processes and its willingness to commit the necessary resources to meet FDA expectations. The lifting of the AIP could not have been accomplished without the hard work of many dedicated Bard employees and the guidance of the FDA." During the AIP, Bard has continued to develop and market angioplasty and angiography products for markets outside the USA. USCI intends to immediately begin submitting both new 510(k) and PMA supplement applications for these and other products to the FDA. Bard hopes to begin receiving 510(k) approvals on new USCI applications late in 1995, with new PMA supplement approvals beginning sometime in 1996. C. R. Bard, Inc., headquartered in Murray Hill, NJ, is a leading multinational developer, manufacturer and marketer of health care products. CONTACT: E. L. Parker C.R. Bard, Inc. (908) 277-8059 |
|
||||||||||||||
Printer friendly
Cite/link
Email
Feedback
Reader Opinion