Bioresearch Monitoring Alert articles from September 2004

Bioresearch Monitoring Alert archives from September 2004

Final FDA guide calls for clinical holds if researchers fail to file SAEs, but finances, record-keeping faults not listed.(Misconduct, Food and Drug Administration)
September 1, 2004... FDA has issued a final guidance for clinical holds resulting from investigator misconduct, stating that the agency can hold up a trial before an enforcement action if it finds a failure by researchers to report serious or life-threatening...

SACHRP debates embryonic research and confusion in various subparts.(Embryonic research)(Secretary's Advisory Committee on Human Research Protections)
September 1, 2004... Correspondent WASHINGTON -- The Office for Human Research Protections (OHRP) should issue guidance to interpret how Subpart B of the common rule regarding the requirement that behavioral/social science research must "lead to the development of...

Canada nearly doubles approvals since advent of 7-day reviews in '01.(Clinical trials)(Therapeutic Products Directorate )
September 1, 2004... TORONTO -- Canada's Therapeutic Products Directorate (TPD) has nearly doubled the number of Clinical Trial Applications (CTAs) approved since reforming its review process in 2001 to require a seven-day decision time. While most of the...

Lack of 'Canadian specific documentation' slows some drug submissions; CRF content outline.(Drug review)
September 1, 2004... TORONTO -- Despite Canada's adoption of the Common Technical Document (CTD) in July 2003 to replace previous formats for new drug submissions (NDS), some firms are seeing their applications delayed, in part due to a lack of documentation needed...

FDA audits Minnesota eye facility, slaps one CI with 483, but gives other CI a reprieve.(Clinical investigators, Food and Drug Administration)
September 1, 2004... A for-cause inspection, initiated because of a consumer complaint, yielded an eight-item 483 for David Hardten, M.D., Minnesota Eye Consultants, Minneapolis, for improperly obtaining informed consent and failing to maintain records for some...

Gore nets 3-item 483 for protocol violations in initial inspection.(Clinical Investigators)(investigations against Martin Gore)
September 1, 2004... Martin Gore, M.D., The Royal Marsden Hospital, London, CDER An initial foreign inspection of Martin Gore, M.D., of The Royal Marsden Hospital, London, found the doctor "adhered to most good clinical practices" but a three-item 483 was...

Warning letters.
September 1, 2004... The following are FDA warning letters to clinical investigators, IRBs, sponsor/monitors, CROs and testing labs issued the weeks of July 26 and August 2, 9, 16 and 23. Each letter is $7 plus retrieval. Please order by RECORD-RETRIEVE Number...

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

BiMo FOIA log.(Freedom Of Information Act )
September 1, 2004... The following 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...