Recently added articles from BioResearch Compliance Report:
FDA starts effort to respond to I.G. report on dwindling BiMo audits; Part 11 still a concern.(I.G. Report)(Food and Drug Administration)(Inspector General)
Dec 01, 2007; Cezanne, Jeannette ... 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 Inspector General (I.G.), which has triggered a congressional inquiry. This was the ...
XML a frequent problem with eCTD submissions; speaker says refuse-to-files are painful.(Electronic clinical trials)(electronic common technical document)(Extensible markup language)
Dec 01, 2007; Pickett, Joseph ... 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-file (RTF) decision on NDAs, which with one biotech firm caused it to spiral downward. ...
OHRP still grappling with how to report AEs to IRBs, despite guidance.(Adverse event reporting)(Office for Human Research Protections)(institutional review board)(United States. Food and Drug Administration)
Dec 01, 2007; Cezanne, Jeannette ... 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 the reporting process - notably a federalwide electronic portal for adverse events ...
OHRP asked to review repositories and 'previous consents' in expedited review guidance.(Informed consent/IRBs)(Office for Human Research Protections )(Institutional Review Boards )
Dec 01, 2007; Cezanne, Jeannette ... 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 agency's "Categories That May be Reviewed by the Institutional Review Board (IRB) ...
7-item 483 delivered to clinical investigator for protocol violations.(Clinical investigators)
Dec 01, 2007; Hendrick, Kim ... 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. Investigator Laureen Kononen from the Detroit, MI, District Office conducted the inspection. ...
IRB determination letters.
Dec 01, 2007 ... The following are Compliance Determination Letters for IRBs issued in December 2007 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 letters also are ...
BiMo inspection FOIA log.(Brief article)
Dec 01, 2007 ... 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 imply that a 483 or EIR has been issued, only that ...
