Bioresearch Monitoring Alert articles from November 2004

Bioresearch Monitoring Alert archives from November 2004

EU Clinical Trials Directive needs refining, sponsors say, including informed consent, pediatric rule like FDA's; GCP audits outlined.(International)
November 1, 2004... BALTIMORE -- The European Union's (EU) draft Clinical Trials Directive, which could be enacted next year, still poses some problems for sponsors, including how to take informed consent from minors and harmonizing requirements between the EU and...

"Critical Path Opportunities List" seen speeding approvals.(Clinical trials/pre-clinical)
November 1, 2004... WASHINGTON -- Through extensive consultation with all public and private stakeholders, FDA will soon release a "Critical Path Opportunities List" which will highlight areas of opportunity for the development of new tools to accelerate the...

Concern expressed that CDER's DSI requests information for audits already in review divisions.(BiMo inspections)
November 1, 2004... WASHINGTON -- At least one sponsor has expressed concern that the Division of Scientific Investigations (DSI) in the Center for Drugs is requesting documents prior to doing an inspection of clinical sites, despite the fact the documents already...

Merck fears not realized with EU Clinical Trials Directive.(International)
November 1, 2004... BALTIMORE -- Merck realized that its "fears were not realized" in dealing with the EU Clinical Trials Directive, said William Leslie, Ph.D., senior director of Worldwide Operations at Merck & Company. Addressing the annual meeting here of...

CI slapped with 4-item 483 and warning letter for paperwork flaws.(Clinical investigators)
November 1, 2004... Inadequate study paperwork and failing to ensure proper monitoring of the progress of the investigation netted a four-item 483 and a Dec. 11, 2003 warning letter for Stephen Caldwell, M.D., Universityof Virginia Health Systems, Charlottesville,...

Coast IRB cited for not following SOPs, maintaining adequate documentation in 2-item 483.(independent research board, California)
November 1, 2004... Coast IRB, San Clemente, CA, Irvine District Coast IRB, San Clemente, CA, did not follow written procedures for conducting initial and continuing review of research, and also did not prepare and maintain adequate documentation of IRB...

Test methods at heart of 4-item 483 for Tri-State Analytical Laboratory.(dicipline)
November 1, 2004... Tri-State Analytical Laboratory, Johnson City, TN, New Orleans Division Tri-State Analytical Laboratory, Johnson City, TN received a four-item 483 and an Oct. 23, 2003 warning letter because the accuracy, sensitivity, specificity and...

Warning letters.
November 1, 2004... The following are recent FDA warning letters to clinical investigators, IRBs, sponsor/monitors, CROs and testing labs issued during the month of October 2004. Each letter is $7 plus retrieval. Please order by RECORD-RETRIEVE Number (e.g.,...

NIDPOE letters.
November 1, 2004... The following are Notices of Initiation of Disqualification Proceeding and Opportunity to Explain (NIDPOE) letters. NIDPOEs are available to subscribers from RECORD-RETRIEVE for $7 plus retrieval. James Holland, M.D., Thomasville, GA, Sept....

IRB determination letters.(Letter to the Editor)
November 1, 2004... The following are Compliance Determination Letters for IRBs issued in October 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.
November 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...