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 . . .
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 . . .
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 . . .
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 . . .
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 . . .
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 . . .
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 . . .
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 . . .
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 . . .
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 . . .
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 . . .
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.
. . .
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 . . .
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 . . .
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 . . .
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 . . .
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 . . .
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 . . .
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 . . .
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 . . .
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