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Bioresearch Monitoring Alert articles from March 2005
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Bioresearch Monitoring Alert archives from March 2005
Ex-aide to Waxman and Kennedy says trial disclosure bills too broad, but sees likely passage.(Clinical trial disclosure)
March 1, 2005... NEW YORK--Certain clinical trial information, now cloaked by the pharmaceutical industry's invocation of "proprietary information," may become public under laws currently being considered in Congress, an ex-aide to leading Democrats in...
Medical journals' rule, IND reminders boosts Clinicaltrials.gov registrations.(Investigational New Drug)
March 1, 2005... NEW YORK -- The quantity of drug trials submitted to the joint FDA/National Library of Medicine Clinic altnals.gov database has risen by 300 since September, but the quality of the listings is still lacking, according to the FDA official in...
Avoiding trial liability starts with FDA compliance, attorney says.(Compliance)
March 1, 2005... NEW YORK -- Knowing what's important to FDA and keeping scrupulous records are the keys to avoiding litigation stemming from clinical trials, according to a Washington-based lawyer specializing in compliance law.
"With clinical trials,...
PhRMA hopes voluntary disclosure efforts will garner FDA, public trust.(Clinical trial disclosure)
March 1, 2005... NEW YORK -- Collectively and individually, pharmaceutical makers are hoping voluntary efforts to make clinical trial information more available to the public will generate renewed trust in the industry and hold outside regulatory efforts at...
CI gets 3-item 483 for protocol deviations, subjects entered into study under "Physician's Discretion" also questioned.(Clinical investigators)
March 1, 2005... Richard Lindstrom, M.D., Minnesota Eye Consultants, Minneapolis, MN, Minneapolis District
Richard Lindstrom, M.D., Minnesota Eye Consultants, Minneapolis, MN, received a three-item 483 for failure to report protocol deviations, and...
CI Siegel gets clean report, but investigator details "data irregularities" that led to dismissal of principal study coordinator.(medical investigation)
March 1, 2005... Robert Siegel, M.D., Advanced Cardiac Specialists, Gilbert, AZ, Tucson District
Advanced Cardiac Specialists (ACS), Gilbert, AZ, owned and operated by Robert Siegel, M.D., avoided a 483 because although a deviation noted during a device...
Warning letters.
March 1, 2005... The following are recent FDA warning letters to Clinical investigators, IRBs, sponsor/monitors, CROs and testing labs issued in January 2005. Each letter is $7 plus retrieval. Please order by RECORD-RETRIEVE Number (e.g., 12338W, 12399W,...
IRB Determination Letters.
March 1, 2005... The following are Compliance Determination Letters for IRBs issued in February 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...
BiMo FOIA log.(Freedom of Information Act)(Bioresearch Monitoring )
March 1, 2005... 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...
