Bioresearch Monitoring Alert articles from May 2002

Bioresearch Monitoring Alert archives from May 2002

House members beat Kennedy on introducing human subject protection bill.(United States House of Representatives, Senator Edward Kennedy)
May 1, 2002... The House has beaten the Senate to the punch with regard to introducing legislation to revamp U.S. laws on human subject protection. Reps. Diana DeGette (D-CO) and Jim Greenwood (R-PA) announced on May 9 the introduction of the "Human...

FDA to give two-days notice for clinical investigator audits, sponsor/monitors to follow.(United States Food and Drug Administration)
May 1, 2002... TORONTO - FDA is about to stipulate that all clinical investigators about to undergo a bioresearch monitoring audit, regardless of which center issues the inspection, should be given two days notice. Plus, the same two-days notice will be given...

Canada plans to double BiMo audits, EU to establish trial registry.(government inspection of clinical research, Canada and the European Union)(Brief Article)
May 1, 2002... TORONTO - FDA's counterpart agency in Canada plans to double the number of clinical research site inspections in 2002 while the European Union (EU) is about to establish a clinical trials registry to track where tests in humans are being...

FDA wants better handling of complaints, adverse reports in trials; more foreign audits envisioned.(David LePay, senior advisor at Food and Drug Administration, speaks at Association of Clinical Research Professionals meeting, Toronto, Canada)(Brief Article)
May 1, 2002... TORONTO - Recent FDA bioresearch monitoring inspections have been focusing more so on "real-time issues," such as how clinical trial sites are responding to complaints and adverse events, FDA's top BiMo enforcer told the annual Assn. of...

Biotech fuels CRO growth, contracting newsletter reports.(contract research organizations)(Brief Article)(Statistical Data Included)
May 1, 2002... Contract research organizations (CROs) generally enjoyed a remarkable year in 2001, with revenues up 20% or more at most publicly traded companies. Although Big Pharma is an indispensable component of most CROs' business mix, many vendors and...

Purdue receives 483 for electronic issues, Part 11 compliance problems.(Food and Drug Administration investigates Purdue Pharma L.P.)
May 1, 2002... Purdue Pharma, Stamford, CT, New England District What started out as an audit of Purdue's sponsor/ monitor activities, wound up after seven days in September 2001 as a full-blown review of the drug manufacturer's software used in clinical...

"Significant" procedural lapses earn IRB a write-up.(Texas Applied Biotechnology Services Research Review Committee Institutional Review Board)(Brief Article)
May 1, 2002... Texas Applied Biotechnology Services Research Review Committee Institutional Review Board, Houston, TX, Dallas District The Texas Applied Biotechnology Services Research Review Committee IRB received a two-day visit from FDA inspectors...

Concerns over legibility of records, non-licensed physician involvement highlight inspection.(researcher Navin Nanda, UAB Echol Lab at the University of Alabama)(Brief Article)
May 1, 2002... Navin Nanda, M.D., UAB Echo Lab, Birmingham, AL, New Orleans District Clinical investigator Navin Nanda, M.D., came through his first FDA inspection with only a few scratches, but none so serious enough to warrant coverage by a 483. Nanda...

Investigator dots Is, crosses Ts, earns 'friendly' inspection.(inspection of heart surgeon's practice, Paducah, Kentucky)(Brief Article)
May 1, 2002... J. Kenneth Ford, M.D., The Heart Group, Paducah, KY, Cincinnati District Clinical investigator J. Kenneth Ford, M.D. fared well in a one-day inspection that took place Jan. 26, 2000. The cardiac specialist is in private practice with The...

Ophthalmic study inspection shows 'minor deficiencies'.(Robert Stewart, M.D.)(Brief Article)
May 1, 2002... Robert Stewart, M.D., Houston Eye Associates, Houston, TX, Dallas District Robert Stewart. M.D., had reason to celebrate at the start of the millennium. The clinical investigator enjoyed positive results from an inspection that took place...

BiMo FOIA Log.(inspection records requested under Freedom of Information Act)(Brief Article)
May 1, 2002... 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...

Warning Letters.(issued by the Food and Drug Administration)(Brief Article)
May 1, 2002... The following are recent FDA warning letters to clinical investigators, IRBs, sponsor/monitors and CROs and testing labs issued the weeks of April 8, 15, 22 and 29. Each letter is $7 plus retrieval. Please order by RECORD-RETRIEVE Number (i.e.,...

IRB Determination Letters.(issued by National Institutes of Health Office for Human Research Protections)(Brief Article)
May 1, 2002... The following are Compliance Determination Letters for IRBs issued in April by the National Institutes of Health Office for Human Research Protections (OHRP). Each letter is $7 plus retrieval. Copies of documents related to these letters also...