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Bioresearch Monitoring Alert articles from January 2005
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Bioresearch Monitoring Alert archives from January 2005
FDA eyeing new rules on sub-investigator responsibilities; Part 11 issues discussed at SOCRA.(Clinical investigators)(Food and Drug Administration)(Society of Clinical Research Associates)
January 1, 2005... SAN FRANCISCO -- Concerns over accountability of sub-investigators may lead FDA to revise regulations governing clinical investigators, agency staff told a Society of Clinical Research Associates conference here Jan. 12-13.
Joseph...
FDA's Temple says 7 is legitimate age to ask for child's assent to study.(Pediatric assent)(Food and Drug Administration)
January 1, 2005... The age of seven is an appropriate minimum age to ask for a child's assent to participate in a clinical trial, Center for Drugs Associate Director for Medical Policy Robert Temple, M.D., told the PBS television program "Closer to Truth" in...
FDA working on exploratory INDs in limited human studies.(INDs)(Food and Drug Administration; Investigational New Drug )
January 1, 2005... WASHINGTON -- FDA is currently working on exploratory INDs in very limited human studies "almost as a part of pre-clinical workup," Janet Woodcock, M.D., FDA Acting Deputy Commissioner, said here Jan. 10.
Speaking to a symposium...
FDA, NIH to standardize 'E-Clinicals,' work closer with Medicare program under HHS initiative.(Research)
January 1, 2005... FDA and NIH would team up to standardize electronic clinical trials (E-Clinicals) and cooperate more closely with the Medicare program, particularly for medical devices and pharmaceutical post-marketing surveillance, according to a new report...
Novartis cited for QC, protocol and data reporting failures in 8-item 483.(GLPs)
January 1, 2005... Novartis Pharmaceuticals, Corp., East Hanover, NJ, Parsippany District
An eight-item 483 prepared by investigators Peter Lenahan and Rodney Allnutt from the Parsippany District Office cited Novartis Pharmaceuticals, Corp. for flaws in...
Warning letters.
January 1, 2005... The following are recent FDA warning letters to clinical investigators, IRBs, sponsor/monitors, CROs and testing labs issued in December 2004. Each letter is $7 plus retrieval. Please order by RECORD-RETRIEVE Number (e.g., 12338W, 12399W,...
IRB determination letters.(Internal Revenue Bulletin)(Brief Article)
January 1, 2005... The following are Compliance Determination Letters for IRBs issued in December 2004 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...
BiMo FOIA log.(Statistical Process Control; Freedom of Information Act)
January 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...
