Bioresearch Monitoring Alert articles from April 2005

Bioresearch Monitoring Alert archives from April 2005

Justice Department eyeing more oversight of clinical trials, subject protection; PhRMA attorney critical.(Compliance/litigation)
April 1, 2005... PHILADELPHIA -- The Department of Justice (DOJ) is moving aggressively into overseeing clinical trials compliance, according to Jim Sheehan, associate U.S. attorney in the U.S. Attorney's Office in Philadelphia, PA. Addressing the...

Publishing trial information in a public registry may pose new ethical questions.(Registries)
April 1, 2005... PHILADELPHIA -- The subject of a mandatory clinical trials registry, based on the recommendation last summer from the American Medical Assn., was discussed at length during the Pharmaceutical Compliance Summit, held here March 30-April 1. ...

'Compassionate use' provision for a device with IDE, without only in limited circumstances.(Medical devices)
April 1, 2005... WASHINGTON -- To provide early or expanded access to unapproved investigational medical devices, it is possible to qualify under the "compassionate use" provision with or without an IDE. However, the provision is intended for a small group of...

With trials approaching $25,000 per subject, need to have more patients per site grows.(Clinical trial economics)
April 1, 2005... It now costs about $25,000 per subject to be enrolled in a clinical trial for a new drug, largely due to the cost of monitors and other staff to oversee the study. This means for a large cardiovascular drug trial--which can sometimes number...

No transitions exist between GLP and GMP; both need to be followed.(GLPs)
April 1, 2005... WASHINGTON -- Toxicology and other non-clinical labs should be skilled in Good Manufacturing Practice (GMP) regulations as well as Good Laboratory Practice (GLP) rules, as there are "no transitions between GLP and GMP," a biotechnology...

12-item 483 for CI highlights examples of poor trial site oversight.(Clinical investigators)
April 1, 2005... Charles Chesnut, M.D., University of Washington, Seattle, WA, Bothell, WA, District Charles Chesnut, M.D., University of Washington, Seattle, WA, received a 12-item 483 for inadequate informed consent procedures, "various study staff'...

Bioreliance receives clean bill of health, insufficiently documented QC procedures noted.(GLPs)
April 1, 2005... Bioreliance invitrogen bioservices, Rockville, MD, Rockville Division A routine GLP inspection of the nonclinical laboratory BioReliance invitrogen bioservices, formerly BioReliance Corporation, Rockville, MD, netted no 483 for the firm,...

Warning letters.(Brief Article)
April 1, 2005... The following are recent FDA warning letters to clinical investigators, IRBs, sponsor/monitors, CROs and testing labs issue din march 2005. Each letter is $7 plus retrieval. Please order by RECORD-RETRIEVE Number (e.g., 12338W, 12399W, etc.)....

NIDPOE letters.
April 1, 2005... The following are Notices of Initiation of Disqualification Proceeding and Opportunity to Explain (NIDPOE) letters. NIDPOEs are available to subscribers from RECORD-RETRIEVE for $7 plus retrieval. Martha H. Hagaman, M.D., Hermitage, TN,...

IRB determination letters.
April 1, 2005... The following are Compliance Determination Letters for IRBs issued in March 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.
April 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...