Bioresearch Monitoring Alert articles from September 2001

Bioresearch Monitoring Alert archives from September 2001

CBER wants to disqualify investigators within six months not six years.(Center for Biologics Evaluation and Research)(Brief Article)
September 1, 2001... DENVER In wake of lax compliance in gene therapy trials, the Center for Biologics is hoping to disqualify errant clinical investigators for all biotech drug trials swiftly by streamlining its enforcement practices. Joseph Salewski, chief...

Hopkins to have more IRBs, work with OHRP, FDA.(Johns Hopkins University, institutional review boards, Office of Human Research Protections, Food and Drug Administration)
September 1, 2001... Johns Hopkins Asthma & Allergy Clinic, Baltimore, Baltimore District Johns Hopkins University's (JHU) experience with a clinical trial implicated in the death of an otherwise healthy volunteer is well known by now, but a pair of FDA...

Industry seen liable for criminal, civil charges if CROs, investigators err.(contract research organization)(Brief Article)
September 1, 2001... Drug, device and biologics companies have the responsibility to monitor and investigate their own clinical trial sites, or else the government might seek criminal charges or civil penalties against the firm not just rogue researchers and...

FDAer sees no recognition of foreign BiMo audits yet.(Brief Article)
September 1, 2001... DENVER FDA is not considering accepting the results of audits and investigations done by European authorities on European clinical investigations, according to Antoine El-Hage of the Center for Drugs Division of Scientific Investigations. At...

Drug/device accountability seen as big sponsor failing.(Brief Article)
September 1, 2001... DENVER The most common deficiencies among test sites when examined by FDA's bioresearch monitoring program auditors are in protocols, source documents, record keeping and actual tracking of the drug being tested, according to Gail Tauscher of...

Parexel EIR reads like mystery novel without a solution.(Brief Article)
September 1, 2001... Parexel International, Waltham, MA, New England District The public portions of an FDA investigator's report on an inspection last year of what happened during a consultant's work on a drug trial reads like a mystery novel, but with no...

Sponsor spurns label advice, lab gets visit.(Brief Article)
September 1, 2001... North American Science Associates, Irvine, CA, Los Angeles District Sometimes a dispute that a contract test laboratory's client is having with FDA can lead to an inspection of the lab's facilities. In one case, an April 23-27, 2000...

Failure to tell IRB of 4 deaths leads to 483s.(Institutional Review Board, Michael Jacoby, Mercy Ruan Neurology Clinic)
September 1, 2001... Michael Jacoby, M.D., Mercy Ruan Neurology Clinic, Des Moines, IA, Kansas City District Clinical investigator Michael Jacoby, M.D., and Mercy Ruan Neurology Clinic, Des Moines, IA, received an eight-item 483 not because four patients had...

IRB complies nearly year, warning later.(Holy Cross Hospital Institutional Review Board)(Brief Article)
September 1, 2001... Holy Cross Hospital Institutional Review Board, Ft. Lauderdale, FL, Florida District Nearly a year after an FDA audit, and then only after a warning letter (Doc. 9583W) was issued urging compliance, Holy Cross Hospital IRB in Fort...

Voting records yield Tulane IRB a 483.(Tulane University Medical Center Institutional Review Board)(Brief Article)
September 1, 2001... Tulane University Medical Center IRB, New Orleans, New Orleans District Items as small as failing to record who abstained from voting were enough to give a 483 to the IRB at Tulane University Medical Center. The board's chairman promised...

BiMo Inspection Log.
September 1, 2001... This is a list of requests for 483s and EIRs for inspections of CROs, testing labs, IRBs and clinical investigators, filed with FDA under the Freedom of Information Act (FOIA). These are only requests for documents. In most cases, these...

Warning Letters.(Food and Drug Administration's warnings to clinical investigators, investigational review boards)(Brief Article)
September 1, 2001... The following are recent FDA warning letters to clinical investigators, IRBs, sponsor/monitors and CROs and testing labs since July 1, 2001. Each letter is $7 plus retrieval. Please order by RECORD-RETRIEVE Number (i.e., 9007W, 9008W, etc.)....

IRB Determination Letters.(institutional review boards)(Brief Article)(Illustration)
September 1, 2001... The following are Compliance Determination Letters for IRBs issued in February and March by the National Institutes of Health Office for Human Research Protections (OHRP). Each letter is $7 plus retrieval. Copies of documents related to these...