BioResearch Compliance Report

Browse past and current articles from this publication.

FDA starts effort to respond to I.G. report on dwindling BiMo audits; Part 11 still a concern.(I.G. Report)(Food and Drug Admini
BOSTON FDA's Human Potential Clinical Steering Committee has recently issued reports and guidance documents in direct response to the unfavorable report issued in October by the HHS Office of the In . . .

XML a frequent problem with eCTD submissions; speaker says refuse-to-files are painful.(Electronic clinical trials)(electronic c
Drug and device sponsors should use caution as they prepare their eCTD submissions for NDAs particularly with XML documents-because failure to follow FDA's strict procedures could yield a refuse-to- . . .

OHRP still grappling with how to report AEs to IRBs, despite guidance.(Adverse event reporting)(Office for Human Research Protec
BOSTON The reporting of adverse events and unanticipated problems varies from FDA to OHRP despite efforts at harmonization, and while there is some effort to get as much consistency as possible into . . .

OHRP asked to review repositories and 'previous consents' in expedited review guidance.(Informed consent/IRBs)(Office for Human
BOSTON -- OHRP is being to determine how repositories of information and "previous consents" will be handled under the agency's proposed expedited review procedures for IRBs. The discussion of the . . .

7-item 483 delivered to clinical investigator for protocol violations.(Clinical investigators)
Kim Hendrick, M.D., Flushing, MI, was hit with a seven-item 483 because the clinical investigator failed to adhere to protocol in the area of independent radiological assessments of sinus X-rays. In . . .

Cutting-edge investigator training vital to protect human safety, particularly in wake of new I.G. report.(Training)
A recent report by the HHS Office of the Inspector General found that FDA each year audits fewer than 1% of the clinical trial sites in the U.S., and these tend to focus on the accuracy of study dat . . .

Compliance assessment avoids harsh criminal penalties.(R&D)
WASHINGTON -- Staying out of trouble with FDA in clinical research requires sponsors to undergo a careful R&D compliance assessment. Areas that should be closely scrutinized include leadership and a . . .

Audiotaping consent sessions seen thwarting lawsuits.(Informed consent)
BOSTON -- Audiotaping the taking of informed consent could provide a helpful backup tool in case a subject or family sues after the trial, the chief of Coast Independent Review Board told the RAPS a . . .

Whatever you call it, low-cost biologics deferred for another day.(Biologics)
BOSTON -- One of the most divisive issues between the generics and innovator industries the last decade remains unresolved despite the passage of FDAAA--what to do about "follow-on" biologics--somet . . .

6-item 483 received by IRB for consent and correspondence records.(IRBs)(Institutional Review Board)(Report)
Stanislaus Surgical Hospital Institutional Review Board, Modesto, CA, was the recipient of a six-item 483 for failing to keep accurate minutes for informed consent, and did not keep correspondence d . . .

BiMo inspection FOIA log.(Freedom of Information Act)(Brief article)
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 I . . .

Sponsor relationship still largely hands off, especially with training: Everest survey.(CROs/sponsors)(Survey)
Just a little over half of clinical trial sponsors train their CRO personnel and 24% don't do any training at all, and investigator training remains a grey area of sponsor/CRO responsibility, a new . . .

PFS preferred regulatory endpoint in oncology trials, AstraZeneca exec says.(Endpoints)(progression free survival )
ARLINGTON, VA -- Progression-free survival (PFS) is the preferable regulatory endpoint in oncology clinical trials over time-to-progression (TTP) endpoints because PFS allows for smaller trial desig . . .

Maier slapped with 3-citation 483 for case history flaws, not reporting AEs.(Clinical investigators)
William Maier, M.D., Eugene, OR, received a 483 with three citations because he failed to maintain accurate case histories. Also, the researcher did not report to the sponsor adverse events (AEs) th . . .

Stroup fails to follow investigational plan, notes 3-item 483.
Steven Stroup, M.D., Nashville, TN, District, received a three-item 483 because his investigation did not conform with the requirements of the investigational plan. Investigator Donna Gallien from . . .

Warning letters.
The following are recent FDA warning letters to clinical investigators, IRBs, sponsor/monitors, CROs and testing labs issued in August 2007. Each letter is $7 plus retrieval. Please order by RECORDR . . .

Senators to reintroduce legislation in wake of Abigail decision: controversial 8-2 court ruling limits experimental drug access
With the U.S. Court of Appeals for the District of Columbia Circuit ruling 8-2 last week that terminally ill patients do not have a constitutional right to obtain access to unapproved prescription d . . .

GCPs likely focus of investigation by energy & commerce panel.(Legislation/oversight)(Good Clinical Practices )
The House Committee on Energy and Commerce soon will launch investigations of the agency's oversight of FDA's handling of Good Clinical Practices (GCPs), according to a Washington attorney with insi . . .

EMEA publishes final guideline to cut risk for early clinical trials.(International)
The European Medicines Agency (EMEA) July 26 published the final guideline on strategies to identify and mitigate risks for first-in-human clinical trials with investigational medicinal products. . . .

Human Tissue Task Force recommends biennial inspection for high-risk HCT/Ps.(Inspections)
FDA could conduct up to 484 inspections of makers of high-risk human cells, tissues, and cellular and tissue-based products (HCT/Ps), under fiscal 2007 resources, thus providing coverage to about 1/ . . .

Clinical investigator clears FDA audit after protocol deviations noted.(Sponsor/monitors)
Issam Raad, M.D., Houston, TX, received a clean inspection from FDA because protocol deviations that had occurred earlier were corrected before the audit was performed. The investigation was condu . . .

Complete Analysis cited in 9-item 483 for faulty laboratory records.(CROs)
Complete Analysis Laboratories, Parsippany, NJ, received a nine-item 483 because the control testing laboratory's records did not include complete data derived from all tests, according to the repor . . .

Center for Spinal Disorders, Thornton, CO, July 3 (Rockville, MD).(Warning Letters)
The following are recent FDA warning letters to clinical investigators, IRBs, sponsor/monitors, CROs and testing labs issued in June 2007. Each letter is $7 plus retrieval. Please order by RECORD-RE . . .

David Linden, M.D., Oklahoma City, OK, July 3 (Rockville, MD).(Warning Letters)(Clinical report)
The following are recent FDA warning letters to clinical investigators, IRBs, sponsor/monitors, CROs and testing labs issued in June 2007. Each letter is $7 plus retrieval. Please order by RECORD-RE . . .

IRB determination letters.
The following are Compliance Determination Letters for IRBs issued in July 2007 by the Department of Health and Human Services Office for Human Research Protections (OHRP). Each letter is $7 plus re . . .

BiMo inspection FOIA log.(Brief article)
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 I . . .

PPD Development hit with 2-item 483 for analytical run flaws.(CROs/GLPs)
PPD Development, Richmond, VA, was the recipient of a two-item 483 in a 2006 audit because analytical runs were accepted even though more than two out of three quality control samples failed. Cond . . .

Charous gets 483 for failing to follow investigational plan.(Clinical investigators)
Bruce Charous, M.D., Milwaukee, WI, received a one-item 483 because he failed to follow the investigational plan in that the protocol was not completely followed for some study subjects. Investiga . . .

IRB Determination Letters.
The following are Compliance Determination Letters for IRBs issued in June 2007 by the Department of Health and Human Services Office for Human Research Protections (OHRP). Each letter is $7 plus re . . .

BiMo inspection FOIA Log.(Brief article)
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 I . . .

Not following investigational plan top 483 violation for clinical researchers: ORA.(Inspections)
WASHINGTON -- According to ORA investigator Melanie Mayor, who spoke here at the DIA meeting May 11, the most common 483 citations for clinical investigators in FY '05 and FY '06 were: * Investiga . . .

Clinical investigator receives clean report, but consent issues raised.(Clinical investigators)(Clinical report)
Karl Beutner, M.D., Vallejo, CA, received a clean inspection from FDA following a recent pre-approval inspection. Investigator Ingrid Cambrana from the Irvine, CA, District Office conducted the audi . . .

R. McIntyre Bridges, M.D., Shreveport, LA, May 8 (Rockville, MD).(Warning Letters)(Brief article)
The clinical investigator involving medical devices was determined to be in violation of the FD&C Act, in that he did not obtain proper informed consent from his subjects. The letter noted that ma . . .

IRB Determination Letters.
The following are Compliance Determination Letters for IRBs issued in May 2007 by the Department of Health and Human Services Office for Human Research Protections (OHRP). Each letter is $7 plus ret . . .

BiMo inspection FOIA log.(Freedom of Information Act, Bioresearch Monitoring)(Brief article)
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 I . . .

Audit trails, date stamps, stressed in final guidance on computer use in clinical studies.(Computers/Part 11)
The document titled "Final Guidance for Industry Computerized Systems Used in Clinical Investigations" released May 10 supplements the agency's electronic records guidance on 21 CFR Part 11, and str . . .

Liability concerns blocking use of alternative IRB models: report.(IRBs)(Financial report)
IRBs generally are not using alternative review methods because of liability concerns and recommendations by attorneys at their institutions not to pass off responsibility to a central body if resea . . .

Effective clinical study design can minimize FDA and IRB involvement: Temple.(Trial design)(Independent Review Boards)
WASHINGTON -- Quality in a clinical trial typically focuses on accuracy, compliance with recording what was expected and consistency of case report forms (CRFs). Often what is ignored, noted a sen . . .

Warning letters.
The following are recent FDA warning letters to clinical investigators, IRBs, sponsor/monitors, CROs and testing labs issued in April 2007. Each letter is $7 plus retrieval. Please order by RECORD-R . . .

IRB Determination Letters.
The following are Compliance Determination Letters for IRBs issued in April 2007 by the Department of Health and Human Services Office for Human Research Protections (OHRP). Each letter is $7 plus r . . .

BiMo inspection update.(Brief article)
The following is BioResearch Compliance Report's twice-yearly update of newly obtained 483s, EIRs and other documents from our RECORD-RETRIEVE Document Retrieval & Research Service. This listing con . . .

BiMo inspection FOIA log.(Freedom of Information Act )(Brief article)
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 I . . .

For-cause CI inspections dropped to 58 in FY '06, complaints on the rise, officials told.(Inspections)(clinical investigators)(f
ARLINGTON, VA -- For-cause Center for Drugs inspections of clinical investigators dropped to approximately 58 in fiscal year 2006, compared to 70 in FY '05 and 110 in FY '04, according to recently r . . .

26% of IRBs lack written policy on conflict of interest, according to non-government study.(IRBs)(Institutional Review Boards)(S
ARLINGTON, VA -- A study on conflicts of interest at IRBs at 121 U.S. medical schools that receive NIH funding found that 26% of ethics boards surveyed lack written policies on conflicts, an instruc . . .

Rising complaints against clinical researchers lead to low retention rate.(Clinical investigators)(Survey)(Brief article)
ARLINGTON, VA -- About 63% percent of clinical investigators have only one year of experience, 12% have two to four years, and 25% have more than five years, the president of RxTrials, Ellicott City . . .

Inspection nets IRB 483 for minutes flaws.(IRBs)(Institutional Review Boards)
Research Consultant's Review Committee, Austin, TX, was inspected twice by FDA and received a four-item 483 for meeting minute deficiencies, but the second audit found no violations. A warning lette . . .

Part 11 cited for drug manufacturer.(Drug-Part 11 focus)(Interquim SA)(Brief article)
FDA's growing tendency to issue citations for violations of the agency's electronic records and signatures regulation (21 CFR Part 11) was evident in a nine-item 483 for Interquim SA, Barcelona, Spa . . .

Warning letters.
The following are recent FDA warning letters to clinical investigators, IRBs, sponsor/monitors, CROs and testing labs issued in March 2007. Each letter is $7 plus retrieval. Please order by RECORD-R . . .

IRB Determination Letters.
The following are Compliance Determination Letters for IRBs issued in March 2007 by the Department of Health and Human Services Office for Human Research Protections (OHRP). Each letter is $7 plus r . . .

BiMo inspection FOIA log.(bioresearch monitoring)(Freedom of Information Act)
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 I . . .