Lifecore FDA Dispute Resolution Panel Meeting Scheduled for June 4.Business Editors & Medical/Health Writers CHASKA, Minn.--(BUSINESS WIRE)--May 8, 2001 LIFECORE BIOMEDICAL, INC inc - /ink/ increment, i.e. increase by one. Especially used by assembly programmers, as many assembly languages have an "inc" mnemonic. Antonym: dec. . (Nasdaq:LCBM) announced today that a meeting of the Food and Drug Administration's Medical Devices Dispute Resolution Panel (MDDRP) in connection with the Company's PMA PMA (papillary-marginal-attached), n a system of epidemiologic scoring of periodontal disease devised by Schour and Massler in which the symbols denote the areas involved in gingival inflammation. PMA Progressive muscular atrophy application for its ferric ferric (fĕr`ĭk), iron in the +3 valence state. See ferrous. hyaluronate hyaluronate /hy·al·uro·nate/ (hi?ah-ldbobr´ro-nat) a salt, anion, or ester of hyaluronic acid. The sodium salt and a derivative of it are used as analgesics in the treatment of osteoarthritis of the knee. product, GYNECARE INTERGEL(a) Adhesion Prevention Solution is currently scheduled for June 4, 2001. The dispute resolution process is outlined under the provisions of the FDA FDA abbr. Food and Drug Administration FDA, n.pr See Food and Drug Administration. FDA, n.pr the abbreviation for the Food and Drug Administration. Modernization Act of 1997 and was discussed at an introductory meeting of the MDDRP on October 31, 2000. Les Weinstein, Ombudsman in FDA's Center for Devices and Radiological Health The Center for Devices and Radiological Health (CDRH) is the branch of the United States Food and Drug Administration responsible for the premarket approval of all medical devices, as well as overseeing the manufacturing, performance and safety of these devices. (CDRH CDRH Center for Devices and Radiological Health (US FDA) ) and Panel Executive Secretary, is authorized to convene a meeting of the MDDRP when he deems it appropriate to resolve issues of scientific dispute between a PMA applicant and the FDA. The Panel consists of eight members: three permanent scientific voting members, three temporary voting members with specialized expertise in the ad hoc scientific areas of dispute, and two non-voting members representing both the medical device industry and consumer interests. GYNECARE INTERGEL Solution has been under evaluation in pivotal human clinical trials since March 1996. The current premarket approval application was filed with the FDA in March 1999 and formally accepted for expedited review in May 1999. The product was initially determined to be not approvable by a recommendation of the January 12, 2000 General and Plastic Surgery Devices Advisory Panel. In June of 2000 the Company filed a major amendment to the PMA to address the concerns raised at the January Panel meeting. After review of the amendment, FDA's Office of Device Evaluation (ODE) determined that, while the results of clinical testing may appear to be encouraging, in their opinion there was not sufficient information to demonstrate reasonable assurance of safety and effectiveness. Thus, ODE concluded that the PMA is not approvable at this time and notified the Company of options for agency review of ODE's determination. GYNECARE, the women's healthcare division of ETHICON, INC. a Johnson & Johnson Company, currently markets Lifecore's ferric hyaluronate outside the US in 25 countries under the trademark GYNECARE INTERGEL Adhesion Prevention Solution, and has US marketing rights. Further information is available at the FDA website: http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfAdvisory/ details.cfm?mtg=251. (Please note: Due to the length of this URL URL in full Uniform Resource Locator Address of a resource on the Internet. The resource can be any type of file stored on a server, such as a Web page, a text file, a graphics file, or an application program. , it may be necessary to cut and paste To move an object from one location to another. When the operation is complete, there is nothing left in the original location. It may refer to relocating files from one folder to another or to relocating selected text or images from one document to another. this hyperlink into your Internet browser's URL address field.) Certain statements in this release are forward-looking statements as defined in the Private Securities Litigation Reform Act The Private Securities Litigation Reform Act of 1995 (PSLRA) implemented several significant substantive changes affecting certain cases brought under the federal securities laws, including changes related to pleading, discovery, liability, class representation and awards fees and of 1995. Statements implying timing or outcome of the FDA review process and the MDDRP are subject to change. Because of numerous risks and uncertainties in the complex regulatory aspects of Lifecore's business activity, actual results may differ materially from those implied. Investors are strongly cautioned to review more detailed discussions of those risks presented in the Company's Forms 10-Q and 10-K. Lifecore Biomedical produces biomaterials and medical devices for various surgical markets and provides specialized contract aseptic manufacturing services. Additional general corporate information about Lifecore is available on the Internet at http://www.lifecore.com (a) Trademark of ETHICON, INC. |
|
||||||||||||||

Printer friendly
Cite/link
Email
Feedback
Reader Opinion