Center for Special Immunology
Florida-based clinical research subsidiary of Health Professionals, Inc. receives Aug. 12 FDA warning letter for record-keeping inadequacies and altering admission criteria in two studies: a Roche-sponsored trial comparing ddC (Hivid) and AZT (Burroughs Welcome's Retrovir) monotherapy; and a trial of Adria's Mycobutin (rifabutin) for mycobacterium avium complex. The warning letter directed to CSI Principal Investor and CEO William Reiter, MD, resulted from a 14 month FDA investigation and presents affidavits of former CSI employees that allege Reiter requested alterations of patient entry T4 cell count results to allow patients to enroll into the studies who otherwise would not have qualified. The allegations contradict previous affidavits, from some of the same employees, submitted to FDA at the beginning of the investigation by attorneys for CSI. While the warning letter states that CSI could be subject to future enforcement action, CSI said Aug. 30 the agency told the organization that "the FDA findings did not warrant any official action and that the FDA has no present intention of pursuing any administrative or other enforcement action." CSI notes that it has added a quality assurance group and requires that all records are accurately maintained...
You may also be interested in...
Newly released Medicare Part D data sheds light on the sales hit that branded pharmaceutical manufacturers will face when the coverage gap discount program gets under way in 2011
FDA appears headed for a showdown with clinicians and the pharmaceutical industry over the proposed new clinical trial endpoints for acute bacterial skin and skin structure infections, the guidance's approach for justifying a non-inferiority margin and proposed changes in the types of patients that should be enrolled in trials
Specialty drug maker Shire has quietly begun scouting deals with a brand-new $50 million venture fund, the latest of several in-house investment arms to launch with their parent company's pipelines, not profits, as the measure of their worth