Bioresearch Monitoring Alert articles from March 2004

Bioresearch Monitoring Alert archives from March 2004

Title 42 'loophole' at heart of NIH conflict probe by Congress; top NIH staff seen having to disclose income.(Conflict of interest)
March 1, 2004... BETHESDA, MD -- The expanded use of an obscure statute allowing private industry to finance government experts appears to be at the heart of a brewing conflict-of-interest scandal involving National Institutes of Health and the receipt of...

NIH defends CRADAs, outside income for scientists.(Research)(Cooperative Research and Development Agreements)
March 1, 2004... BETHESDA, MD -- National Institutes of Health earned approximately $53 million in royalties in 2003 from private industry in Cooperative Research and Development Agreements (CRADAs), reported Barbara McGarey, an NIH legal adviser, during the...

AHRQ head seeks closer ties with FDA on medical errors.(Patient protection)(Agency for Healthcare Research and Quality)
March 1, 2004... PHILADELPHIA -- The U.S. Agency for Healthcare Research and Quality (AHRQ) is seeking to narrow what its director called "the knowledge gap" by expanding outcomes research, including primary care practice-based research networks (PBRNs), and...

Slow move to electronic trial records is best.(Electronic data capture)
March 1, 2004... PHILADELPHIA -- In the era of instantaneous information, pharmaceutical executives have come face-to-face with one of the major stumbling blocks to better clinical trials--namely cleaner, quicker data. Hence, executives involved with the...

Diagnostic Products Corp. says it is placed on FDA's AIP list.(Application integrity)
March 1, 2004... FDA has placed Diagnostic Products Application Integrity Policy (AIP) violations Corp. (DPC) on its list for based on BiMo inspectional findings related to the company's Chagas diagnostic test application. AIP is among the most serious...

FDA says IRB member worked for sponsor, but reviewed protocols.(IRBs)(United States. Food and Drug Administration)(Institutional Review Boards)
March 1, 2004... North Texas Institutional Review Board, Arlington, TX, Dallas District An FDA inspection of North Texas Institutional Review Board (NTIRB) discovered that the director of research for a sponsor also was a voting member of NTIRB and...

FDA finds CI falsified data to sponsor; no NIDPOE letter issued.(Clinical investigators)(Notice of Initiation of Disqualification Proceedings and Opportunity to Explain)
March 1, 2004... Leonard Caputo, M.D., the Asthma and Allergy Institute, Mobile, AL, New Orleans District A sponsor complaint that Leonard Caputo, M.D., of the Asthma and Allergy Institute, Mobile, AL, falsified data initiated this compliance follow-up...

CI receives 483 for failing to report adverse events to sponsor and IRB.(Clinical investigators)(Institutional Review Boards)
March 1, 2004... Timothy Talbert, M.D., Diagnostic Center, Chattanooga, TN, New Orleans District Serious unanticipated adverse events, including a patient death were not reported in sufficient time to neither the sponsor, Biosense Webster, nor the review...

CI says first FDA inspection was 'positive experience'.(Clinical investigators)(United States. Food and Drug Administration)
March 1, 2004... Steven Slade, M.D., The Laser Center, Houston, TX, Dallas District Steven Slade, M.D., Dallas, TX, had only good things to say about FDA investigator Andrea Branche of the Dallas District, who conducted his initial audit. Not surprisingly,...

Warning letters.
March 1, 2004... The following are recent FDA warning letters to clinical investigators, IRBs, sponsor/monitors, CROs and testing labs issued the weeks of Feb. 9, 16, 23 and March 1, 2004. Each letter is $7 plus retrieval. Please order by RECORD-RETRIEVE Number...

IRB determination letters.(Institutional Review Boards)
March 1, 2004... The following are Compliance Determination Letters for IRBs issued in December and January by the Department of Health and Human Services Office of Human Research Protections (OHRP). Each letter is $7 plus retrieval. Copies of documents related...

BiMo FOIA log.(Freedom of Information Act)
March 1, 2004... This is a list of FOIA requests for copies of 483s and EIRs for inspections of CROs, testing labs, sponsor/monitors, IRBs and clinical investigators, which were filed with FDA under the Freedom of Information Act (FOIA). This list does not...