Research Practitioner articles from July 2006

Research Practitioner archives from July 2006

New FDA labeling regulations.(Food and Drug Administration)
July 1, 2006... New FDA labeling rules went into effect on June 30, 2006. FDA had announced in January that it was making a major revision to the format of prescription drug information, commonly called the "package insert." The effort aimed to reduce...

Prescribing behavior and participating in clinical trials.(In the News)
July 1, 2006... Do physicians change their prescribing patterns if they are participating in a clinical trial? A study published in the June 21 issue of the Journal of the American Medical Association evaluated how conducting a pharmaceutical...

When to end a clinical trial.
July 1, 2006... One of the most challenging decisions in clinical research, offer deciding that a clinical trial is justified, is determining when to end the trial. Typically, substantial effort and discussion goes into the decision to conduct a trial in the...

Identification and management of financial conflict of interest in clinical research.
July 1, 2006... In the past 5-10, years a number of government officials and leaders in the medical research community have attempted to improve the identification and management of financial conflict of interest in clinical trials. Guidelines have been...

Exam for continuing education research practitioner 7.4.
July 1, 2006... 3 CE hours 3 CME hours When to end a clinical trial 1.5 CE hours 1.5 CME hours 1. English physician Edward Jenner was known for: A. injecting cows with smallpox virus to test their immunity. B. employing the...

Turning the tables on informed consent.(ISSUES IN HUMAN SUBJECTS RESEARCH)
July 1, 2006... Both regulatory and ethical guidelines require understandable consent forms for prospective subjects. Because typical consent forms are long, complicated, and hard to understand, regulators often recommend consent forms be written at a...

Bioterror diagnostic tests receive informed consent exception.(Regulatory Update)
July 1, 2006... In the June 7, 2006, Federal Register, FDA issued an interim final rule to amend its regulations to establish a new exception from the general requirements for informed consent, to permit the use of investigational in vitro diagnostic (IVD)...

OHRP weighs in on FDA interim rule.(Regulatory Update)
July 1, 2006... On June 7, 2006, OHRP issued a guidance document titled Applicability of 45 CFR part 46 to Clinical Investigations Conducted Under FDA's Interim Final Rule at 21 CFR 50.23(e). This document addressed how to determine whether HHS regulations...

FDA withdraws final rule.(Regulatory Update)
July 1, 2006... In the May 2, 2006, Federal Register, FDA announced it was withdrawing the direct final rule published in the January 17, 2006, Federal Register to amend its current good manufacturing practice regulations for human drugs, including...

FDA issues final guidance documents.(Regulatory Update)
July 1, 2006... Antiviral product development In the June 5, 2006, Federal Register, FDA published a notice announcing the availability of a guidance for industry titled Antiviral Product Development--Conducting and Submitting Virology Studies to the...

FDA issues draft guidance documents for comment.(Regulatory Update)
July 1, 2006... Bayesian statistics for medical device clinical trials In the May 23, 2006, Federal Register, FDA published a notice announcing the availability of a draft guidance for industry titled Guidance for the Use of Bayesian Statistics in...