Bioresearch Monitoring Alert articles from November 2005

Bioresearch Monitoring Alert archives from November 2005

FDA BiMo Initiative focusing on greater use of central IRBs, reforming AE reporting to IRBs.(BiMo)
November 1, 2005... BETHESDA, MD -- FDA's nearly year-old Bioresearch Monitoring Initiative is focusing increasingly on how to improve adverse event reporting to IRBs, greater use of central IRBs and focusing BiMo inspection resources on higher risk-clinical...

New FDA acting commissioner indicates faster drug approvals and strong drug safety not mutually exclusive.(Drug approval)
November 1, 2005... BETHESDA, MD -- New FDA Acting Commissioner Andrew von Eschenbach, M.D., wants to speed the approvals of new drugs to as fast as six to eight weeks by "engaging on the front end during the application process to shorten timelines," while...

Directive requires 'third' countries to comply with GCPs to support EU marketing authorization.(Clinical trials)
November 1, 2005... BALTIMORE -- The European Clinical Trial Directive does not apply outside of the European Union (EU), but in order to support a marketing authorization application in the EU, clinical trials performed in 'third party' countries must comply with...

Assigning QA responsibilities in conduct of non-clinical trials seen as key challenge.(GLPs/CROs)
November 1, 2005... PHILADELPHIA -- One aspect of GLP compliance that stands paramount, but one that often is given short shrift, is the assignment of responsibility. The actual person or persons who are responsible for maintaining compliance throughout the...

'Regulatory compliant research' advised to firms seeking to comply better with GLPs.(GLPs)
November 1, 2005... PHILADELPHIA -- Biopharmaceutical companies seeking to institute a comprehensive, interdisciplinary approach to regulatory compliance need to "challenge outdated attitudes" in order to be successful. This is according to Patrick DeVillier,...

Minor deficiencies noted, but CI lauded for good documentation and thorough monitoring.(Clinical investigators)
November 1, 2005... Albert LoBuglio, M.D., Georgia Cancer Specialists, Atlanta, Atlanta District A follow-up inspection of Albert LoBuglio, M.D., at Georgia Cancer Specialists in Atlanta found similar minor deficiencies as in the last inspection, but...

Ritch escapes 483, but inspector warns CI is responsible for "assuring all study requirements are met".(clinical investigators)
November 1, 2005... Paul Ritch, M.D., Milwaukee, Minneapolis District Paul Ritch, M.D., was not issued a 483 following a recent FDA data audit regarding his role as a clinical investigator, but FDA inspector Investigator Denise Burosh from the Minneapolis...

CRO cited in 3-item 483 for omitting numerous protocol objectives, procedures in firm's final study report.(contract research organization)
November 1, 2005... Charles River Labs Discovery and Development Services, Worcester, MA, Stoneham, MA, District A three-item 483 for Charles River Labs Discovery and Development Service, Worcester, MA, stated: "The final study report did not include the...

Galbraith Labs fails to follow SOPs in 3 analytical investigations.
November 1, 2005... Galbraith Labs, Knoxville, TN, New Orleans District Failure to follow SOPS in three analytical investigations (AIs) and improper equipment qualifications were two observations cited in a three-item 483 for Galbraith Labs, Knoxville, TN....

Warning letters.
November 1, 2005... The following are recent FDA warning letters to clinical investigators, IRBs, sponsor/monitors, CROs and testing labs issued in October 2005. Each letter is $7 plus retrieval. Please order by RECORD-RETRIEVE Number (e.g., 12338W, 12399W, etc.)....

NIDPOE letters.
November 1, 2005... 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. Jeffrey McLeod, M.D., Midlothian, VA, Aug....

IRB determination letters.(Brief Article)
November 1, 2005... 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.(Brief Article)
November 1, 2005... 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...