Bioresearch Monitoring Alert articles from September 2002

Bioresearch Monitoring Alert archives from September 2002

BiMo inspections undecided under CDER/CBER review consolidation, but CDER to handle pre-approval audits. (FDA management).
September 1, 2002... The Center for Drugs at FDA will take over pre-approval inspections for biotech drug products from the Center for Biologics under a new consolidation plan, but the two centers have not formally decided to combine bioresearch monitoring...

Draft clinical hold guidance designed to protect patients from "serious threats" to safety. (Clinical trials).
September 1, 2002... A newly-issued FDA draft guidance document describes when and how the agency can impose clinical hold procedures in situations involving clinical investigators who have committed serious violations or reported false data to study sponsors....

NHRPAC issues pediatric research report, seeks to clarify "minimal risk". (Human subject protections).
September 1, 2002... The National Human Research Protections Advisory Committee (NHRPAC) recently issued the final report from its Children's Workgroup, seeking to clarify several issues surrounding research involving children. Office of Human Research...

CBER and CDER have long history of being lumped together and split up.
September 1, 2002... FDA's move to transfer therapeutic drug reviews from CBER to CDER represents the first downscaling of CBER's regulatory empire since the two centers were broken up in 1987 by then Commissioner Frank Young, M.D. Since that time, CBER has...

Clinical drug manufacturing up 400% in five years, more done overseas. (Clinical supplies).
September 1, 2002... PHILADELPHIA -- The manufacturing of drugs used in clinical trials jumped 400% from 1997 to 2000 with more and more being produced overseas, a Pfizer representative told a Sept. 9 meeting of the International Society of Pharmaceutical...

IRB relies on hospital bylaws over FDA regulations, draws 483, warning letter. (IRBs).
September 1, 2002... Bayshore Community Hospital IRB, Holmdel, NJ, New Jersey District A 483 and subsequent warning letter issued to the Bayshore Community Hospital IRB, Holmdel, NJ, focused primarily on SOP shortcomings and the lack of a quorum at IRB...

Sponsor/Investigator receives 483, warning letter for slew of violations. (Sponsors/Investigators).
September 1, 2002... R. Cem Cezayirli, M.D., Haynes Neurosurgical Group, Birmingham, AL, New Orleans District Failure to submit an IND application before initiating use of an investigational activated cell product in human subjects was a standout citation on...

Investigator says CRO failed to explain study properly. (Clinical investigators).
September 1, 2002... Robert W. Block, M.D., University of Oklahoma Health Sciences Center, Tulsa, OK, Dallas District Not understanding a study as it was explained by the CRO could have contributed to problems that resulted in a 483 for Robert Block, M.D....

Failure to report adverse events draws citation for yet another investigator.
September 1, 2002... Jack G. Caton, D.D.S., University of Rochester, Rochester, NY, New York District Clinical investigator Jack Caton of the University of Rochester's Eastman Department of Dentistry received two 483s in as many inspections, with hits from...

Inspection update: additional response from William Patterson, Birmingham Research Group.
September 1, 2002... In a follow-up to the analysis of the inspection of William M. Patterson, M.D., (see August issue, page 12), a representative of Birmingham Research Group provided a copy of Patterson's written response to FDA's Aug. 30, 2001, warning letter....

BiMo FOIA Log.
September 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...

IRB Determination Letters.
September 1, 2002... The following are Compliance Determination Letters for IRBs issued in August 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...