BLOOD & BIOLOGICS.10276WBiogen, Cambridge, MA, March 29 (CBER-Office of Compliance and Biologics Quality). 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. stated it had received a complaint regarding the firm's press release appearing on the firm's Web site for Avonex (interferon beta interferon beta Fibroblast interferon IFN-β A 20 kD anti-viral protein with 30% 'homology' with IFN alpha, encoded on chromosome 9, produced by fibroblasts in response to viruses or polyribonucleotides 1a) and that it had informed Biogen that a proposed primary endpoint, the Multiple Sclerosis Functional Composite (MSFC MSFC Marshall Space Flight Center MSFC Multilayer Switch Feature Card (Cisco Systems) MSFC Medical Students For Choice MSFC Metropolitan Sports Facilities Commission (Minneapolis, MN) ), had not been validated as a clinical efficacy outcome measurement and hence was inappropriate for use in a Phase III Noun 1. phase III - a large clinical trial of a treatment or drug that in phase I and phase II has been shown to be efficacious with tolerable side effects; after successful conclusion of these clinical trials it will receive formal approval from the FDA study. According to according to prep. 1. As stated or indicated by; on the authority of: according to historians. 2. In keeping with: according to instructions. 3. the letter, the information regarding MSFC appeared in the headline and in claims in the release. The agency wrote that on Nov. 22, 2000, it had sent a letter to Biogen regarding violative materials in two brochures, two journal ads, a sales sheet, a Dear Doctor letter and a press release citing the firm for false and misleading statements and for lack of fair balance. Similar deviations were noted in a letter to Biogen regarding a press release in December. The date of the press release was Jan. 16. BiMo, Web 10277W Dr. Arnold Rubin, M.D., Paterson, NJ, April 3 (CBER-OCBQ). FDA's review of the clinical investigator's work at St. Joseph's Hospital and Medical Center St. Joseph's Hospital and Medical Center is a hospital in Phoenix, Arizona, USA. It is currently operated by Catholic Healthcare West. Services St. Joseph's is a certified level I trauma center for adults. in Paterson, NJ, resulted in citations for performance of protocols prior to obtaining signatures on informed consent documents and for failure of informed consent documents to disclose that some of the costs of participation may not be covered by the subject's insurance. The letter stated that dosing records for 10 subjects were incomplete and that the physician did not inform the sponsor of 29 adverse events. The agency alleged that the sponsor's label was missing for 16 out of 117 doses of an unnamed study article, which would have disclosed activity in milliCuries and information about isotope characteristics. The unnamed investigators concluded their review of Rubin's work on Nov.1, 2000. BiMo 10278W St. Luke's St. Luke's or St Luke's can refer to:
New York, Middle Atlantic state of the United States. It is bordered by Vermont, Massachusetts, Connecticut, and the Atlantic Ocean (E), New Jersey and Pennsylvania (S), Lakes Erie and Ontario and the Canadian province of , NY, April 12 (New York). The letter cited the blood bank for failure to discard a unit of blood that tested repeat reactive for hepatitis C Hepatitis C Definition Hepatitis C is a form of liver inflammation that causes primarily a long-lasting (chronic) disease. Acute (newly developed) hepatitis C is rarely observed as the early disease is generally quite mild. , components of which were transfused into two patients. FDA also cited St. Luke's for failure to defer and notify the donor of the results of the test. The unnamed investigator inspected St. Luke's March 8, 12, 13, 15 and 21. 10279W Stough Enterprises, Cincinnati, OH, April 18 (Minneapolis). The agency wrote that the inspection of Milwaukee Blood Plasma/dba Plasma Care disclosed lack of proper validation protocols for a computer system and for allowing a donor to donate more frequently than permitted by regulations. The investigators documented donor screening personnel "reading the questions too quickly for the donor to respond to prior to...entering the information" into a computer. FDA reminded the firm that it received a warning letter (Doc. 9317W) dated Aug. 14, 2000, and stated that a meeting between Stough and the agency was scheduled for May 1. Val |
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