Bioresearch Monitoring Alert articles from February 2004

Bioresearch Monitoring Alert archives from February 2004

GCP inspections to be nation-based; pharma firms advised to 'get it right first time' for Phase I trials.(EU Clinical trials)(Good Clinical Practices)
February 1, 2004... WASHINGTON -- The European Union's Good Clinical Practices directive is still not finalized, although it is slated to go into effect May 1, and it looks unlikely that many member states in the EU will make the deadline, but one thing is...

Canada aims for 7-day approval for Phase I trials; rules redefine sponsors.(Canada)
February 1, 2004... WASHINGTON -- Canada began overhauling its clinical trials program in the mid 1990s in an effort to provide more protection to research participants. The new regulations, which became effective September 2001, allow more interaction with...

Canadian CRO says shortened approval time means efficiency.(Special report: international clinical trials)(clinical research)
February 1, 2004... WASHINGTON -- Edward Sellers, M.D., president and CEO, Ventana Clinical Research Corp., Canada, said he initially had concerns that Canadian regulatory authorities would not be able to meet the seven-day goal in approving Phase I clinical...

EU hopes GCP Directive will improve trials competition, boost pediatric studies.(EU clinical trials)(Good Clinical Practice)
February 1, 2004... WASHINGTON -- Probably the biggest impact of the EU's GCP Directive, which becomes effective May 1, is the requirement to get regulatory authorization from each member state before beginning Phase I clinical trials. Europe is seeing...

EU deadline will have no impact on Netherlands trial approvals; yet urges applications before May 1 to avoid hassles.(Special report: international clinical trials)(Pharma Bio-Research Group BV)
February 1, 2004... The Netherlands has gotten a running jump on the EU directive, having transposed it into Dutch law Dec. 16, 2003. According to H.D. Veldhuis, Ph.D., director, clinical pharmacology, Pharma Bio-Research Group BV, the Netherlands, most of the...

CI dismayed with 483, 'meat inspector's' audit.(Clinical Investigators)(J. Thaddeus Beck, Highlands Oncology Group)
February 1, 2004... J. Thaddeus Beck, M.D., Highlands Oncology Group, Springdale, AR, Dallas District Although Clinical Investigator J. Thaddeus Beck, M.D., has not been inspected by FDA since his initial audit in November 2001--which resulted in a 483--he...

Sponsor/investigator keeps enrolling patients despite warnings to stop.(Sponsors/Investigators)
February 1, 2004... Blair Ford, M.D., The Neurological Institute, Columbia-Presbyterian Medical Center, New York Presbyterian Hospital, New York, NY, New York District Sponsor/investigator Blair Ford, M.D., received a 483 and subsequent warning letter from...

Sponsor TAP gets clean report from FDA.(Sponsors/Investigators)(TAP Pharmaceutical Products Inc.)(United States. Food and Drug Administration)
February 1, 2004... TAP Pharmaceutical Products, Deerfield, IL, Chicago District FDA's Bruce McCullough from the Chicago District showed up at the doors of TAP Pharmaceutical Products unannounced to investigate the firm's procedures for monitoring clinical...

FDA shows up to find firm liquidating its assets.(GLP)(United States. Food and Drug Administration)(Pharmacology and Toxicology Research Laboratory)
February 1, 2004... Pharmacology and Toxicology Research Laboratory, Richmond, KY, Cincinnati District When Cincinnati District's Thomas Nojek showed up to inspect Pharmacology and Toxicology Research Laboratory, he found the firm in the process of sorting...

Warning letters.
February 1, 2004... The following are recent FDA warning letters to clinical investigators, IRBs, sponsor/monitors, CROs and testing labs issued the weeks of Jan. 12, 19, 26 and Feb. 2, 2004. Each letter is $7 plus retrieval. Please order by RECORD-RETRIEVE Number...

IRB determination letters.(Institutional Review Board )
February 1, 2004... The following are Compliance Determination Letters for IRBs issued in December and January by the Department of Health and Human Services Office for Human Research Protections (OHRP). Each letter is $7 plus retrieval. 12/01/2003 Columbia...

BiMo FOIA log.(Freedom of Information Act)
February 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...