Bioresearch Monitoring Alert articles from December 2004

Bioresearch Monitoring Alert archives from December 2004

Sen. Grassley to offer legislation to create trials registry, split Office of Drug Safety from CDER.(Clinical trials)
December 1, 2004... Senate Finance Committee Chairman Charles Grassley (R-IA) plans to introduce legislation to create a clinical trials registry so the public can access information about drugs in study and split the Center for Drugs Office of Drug Safety from...

Pressure building for FDA to mandate post-approval studies after Vioxx incident.(Phase IV studies)(Food and Drug Administration)
December 1, 2004... WASHINGTON -- Talk has emerged here about Congress giving FDA the authority to mandate the completion of post-approval (Phase IV) studies, primarily due to the recent concerns over Vioxx and other yanked drugs that allegedly caused death and...

Investigator's Brochure should focus on informing multiple stakeholders: Bayer exec.(SOPs)
December 1, 2004... WASHINGTON -- The SOP for an Investigator's Brochure (IB) must inform multiple stakeholders, demonstrate scientific rationale, respond timely to new information, and have an updated DCSI [Development Core Safety Information], noted Ed Tucker,...

RiskMAPs and effective risk assessment needed with agency's new risk-based approach to inspections.(Risk management)
December 1, 2004... WASHINGTON -- New FDA regulations and guidance documents focusing on risk-based approaches mean risk management programs are more important than ever before, thus industry must properly utilize effective risk minimization action plans...

Informed consent and adverse event reporting failures result in 5-item 483 and warning letter for Belmont.(Clinical investigators)
December 1, 2004... Sandra Belmont, M.D., Weill Medical College of Cornell University, New York, NY, New York District Investigators L. Glen Massimilla and Paul Mouris of FDA's New York District Office slapped Sandra Belmont, M.D., with a five-item 483 in an...

NaMSA passes FDA audit with no violations noted.(Non-clinical labs/GLP)(North American Science Associates )(Brief Article)
December 1, 2004... North American Science Associates, Northwood, OH, Cincinnati District A routine GLP inspection of North American Science Associates (NaMSA) Northwood, OH, netted no 483 for the commercial testing laboratory, according to the EIR. The...

TherImmune Research Corp. slapped with 5-item 483 for failing to test control articles and mixtures, protocol violations.(Non-clinical labs/GLP)
December 1, 2004... TherImmune Research Corp., Gaithersburg, MD, Baltimore District TherImmune Research Corp., Gaithersburg, MD, was cited in a five-item 483 for failing "to assure that all test and control articles or mixtures had been appropriately tested...

Warning letters.(BloodNet USA)
December 1, 2004... The following are recent FDA warning letters to clinical investigators, IRBs, sponsor/monitors, CROs and testing labs issued in November 2004. Each letter is $7 plus retrieval. Please order by RECORD-RETRIEVE Number (e.g., 12338W, 12399W, etc)....

IRB determination letters.
December 1, 2004... The following are Compliance Determination Letters for IRBs issued in November 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.
December 1, 2004... 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...