Bioresearch Monitoring Alert articles from June 2003

Bioresearch Monitoring Alert archives from June 2003

Heartmaker drops plans for proxy informed consent; pursues HDE, expands patient base. (Informed consent).(Abiomed, humanitarian device exemption)
June 1, 2003... Abiomed, the Danvers, MA-based device firm that has been experimenting with the AbioCor artificial heart implant, reversed its decision to bypass the written informed consent process for clinical trials, but is trying to avoid full-scale...

Dartmouth and CHOP create clinical trials database. (Clinical trials).(Dartmouth Hitchcock Medical Center, Children's Hospital of Philadelphia )
June 1, 2003... By the end of the year, institutional review boards (IRBs) can anticipate a new tool to help them more efficiently and effectively review clinical studies. BOSTON-Dartmouth Hitchcock Medical Center, Lebanon, NH, and the Children's...

Hopkins failed to have 'effective IND,' toxicity data for Roche study, FDA says. (Enforcement).(Johns Hopkins Asthma & Allergy Center, US Food and Drug Adminstration)
June 1, 2003... Johns Hopkins Asthma & Allergy Center, Baltimore, received a warning letter from FDA March 31, about two years after the highly publicized death of Ellen Roche, 24, who participated in a Hopkins study of the drug hexamethonium bromide. The...

New EU drug law seen spurring GCP; GLP guidance seen by mid-2003. (International).(European Union, Good Laboratory Practice; clinical practices, pharmaceutical law)
June 1, 2003... The European Union (EU) Health Ministers approved a new pharmaceuticals law on June 2, which eventually will lead to more European inspections of clinical and animal research sites. The new directive also increases the number of drugs...

Defense Dept. gets sued for forcing soldiers to participate in anthrax trials. (Human subject protection).(U.S.)
June 1, 2003... The Department of Defense (DoD) is being challenged in federal court about its anthrax vaccine policy, "The Washington Times" reported. Attorneys for six military officers argued in a U.S. District Court that DOD must stop inoculating...

Firm gets wrist slap for minor test-article documentation errors. (GLP).(Bristol-Myers Squibb Co. Pharmaceutical Research Institute)
June 1, 2003... Bristol-Myers Squibb Co. Pharmaceutical Research Institute, Syracuse, NY, New York District After two clean GLP inspections in four years, FDA investigator Russ Davis of the New York District, put an end to that sparkling record when he...

CI/sponsor kept no case report forms or raw data; substitutes study drug without prior approval. (Clinical investigators).
June 1, 2003... Robert Hardaway, M.D., Department of Surgery, Texas Tech University Medical Center, El Paso, TX, Dallas District Gross negligence prompted FDA to investigate clinical investigator and sponsor Robert Hardaway, M.D., for his urokinase...

Investigator stumbles through first FDA audit. (Clinical investigators).(US Food and Drug Administration)
June 1, 2003... Paul Maton, M.D., Digestive Disease Research Institute, Oklahoma City, OK, Dallas District FDA inspector Margaret Ames from the Dallas District showed up unannounced at the doorstep of clinical investigator Paul Maton, M.D., as requested...

CI emerges clean from initial FDA investigation. (Clinical investigators).(John Tesser, M.D., Phoenix Center for Clinical Research)
June 1, 2003... John Tesser, M.D., Phoenix Center for Clinical Research, Phoenix, AZ, Los Angeles District FDA investigator John Nicholson from the Los Angeles District found no objectionable conditions for which to cite John Tesser, M.D., for a study...

Warning letters.(hospitals, research; US Food and Drug Adminstration warnings)(Brief Article)
June 1, 2003... The following are recent FDA warning letters to clinical investigators, IRBs, sponsor/monitors and CROs and testing labs issued the weeks of May 10, 26, June 2 and 10, 2003. Each letter is $7 plus retrieval. Please order by RECORD-RETRIEVE...

Correction.
June 1, 2003... Correction: In our February issue (Page 15), we listed an FDA letter to Medtronic dated Feb. 4, 2002, as a "warning letter" (Doc. 12214W) This in fact was an "untitled letter" from FDA, not a warning letter. We regret this error.

IRB Determination letters.
June 1, 2003... 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.
June 1, 2003... This is a list of FOIA requests for copies of 483s and EIRs for inspections of CROs, testing labs, IRBs and clinical investigators, filed with FDA under the Freedom of Information Act (FOIA). This list does not imply that a 483 or EIR has...