United States clinical trial safety data reporting requirements revised

Kondro, Wayne
November 2010
CMAJ: Canadian Medical Association Journal;11/9/2010, Vol. 182 Issue 16, pE744
Academic Journal
The article reports that the U.S. Food and Drug Administration (FDA) has revised its clinical trial safety data reporting requirements. It notes that the revised FDA regulation will oblige companies to report to the agency within seven to 15 days all results from clinical studies that suggest a significant risk to study participants. The FDA states that the revisions will improve the utility of investigational new drug (IND) and better protect human subjects enrolled in clinical trials.


Related Articles

  • Washington update. Wechsler, Jill // Formulary;Mar1996, Vol. 31 Issue 3, p236 

    Reports on developments concerning the US Food and Drug Administration's (FDA) efforts to improve the review process for drug approval applications in the United States. FDA's report to the Congress about its success in reforming the drug approval process; General Accounting Office's (GAO)...

  • Trial deaths prompt tighter rules. Macilwain, Colin // Nature;11/25/1993, Vol. 366 Issue 6453, p294 

    Reports on the tightening of clinical drug trial regulations by the Food and Drug Administration (FDA). Death of patients following a trial treatment for hepatitis-B by the National Institutes of Health (NIH); Responsibility of sponsoring companies; Investigations conducted by the NIH and the...

  • Guidelines Aim to Speed Drug Approval While Protecting Human Subjects. Mitka, Mike // JAMA: Journal of the American Medical Association;3/1/2006, Vol. 295 Issue 9, p988 

    The article reports that the U.S. Food and Drug Administration released guidelines for pharmaceutical manufacturers and researchers doing investigational new drug (IND) studies. The FDA guidelines define how exploratory IND studies should be managed in humans. The government website is mentioned...

  • The debate over placebo controls continues.  // Drug Utilization Review;Feb2002, Vol. 18 Issue 2, p10 

    Debates on the use of placebo-controlled trials in the United States (U.S.). Circumstances where placebo-controlled trial may be ethically acceptable; How the U.S. Food and Drug Administration accepted the use of placebo-controlled trials when a proven policy exists; Purpose of placebo controls.

  • Testing 1, 2, 3. Kritz, Francesca // Baby Talk;Dec2000/Jan2001, Vol. 65 Issue 10, p20 

    Provides information on the regulation issued by the United States Food and Drug Administration which requires pharmaceutical companies to test their drugs in children before it can be approved. Number of pediatric volunteers needed by the companies to test the drugs; Ethical concern on placebo...

  • An Outsider's Viewpoint: The FDA Should Regulate Clinical Pharmacogenetic/Genomic Tests, But... O'Kane, D // Clinical Pharmacology & Therapeutics;Dec2010, Vol. 88 Issue 6, p746 

    In this article, the author discusses the involvement of the U.S. Food and Drugs Administration (FDA) in clinical pharmacogenetic/pharmacogeniomics (PGx) testing. He says that those people who dislike the involvement of FDA in PGx testing can appeal to change the law or have a patient-centric...

  • Establishing Clinical Utility of Pharmacogenetic Tests in the Post-FDAAA Era. Evans, B. J. // Clinical Pharmacology & Therapeutics;Dec2010, Vol. 88 Issue 6, p749 

    The US Food and Drug Administration (FDA) Amendments Act of 2007, when fully implemented, will offer new sources of evidence and new regulatory mechanisms during the postmarket phase of drug life. If artfully and carefully applied, these new capabilities could help resolve problems that have...

  • Injection Approved for Postmenopausal Women with Osteoporosis.  // Journal of Gerontological Nursing;Sep2010, Vol. 36 Issue 9, p5 

    The article reports on the U.S. Food and Drug Administration's 2010 decision to approve the injection form of the drug Prolia (denosumab) for the treatment of postmenopausal women with osteoporosis who are at high risk for fracture or for patients who have failed or are intolerant to other...

  • New lung cancer treatment awaiting approval from FDA. Rodgers, Katie // Drug Topics;3/7/94, Vol. 138 Issue 5, p26 

    Reports on vinorelbine, the first new drug for lung cancer since 1974 which is awaiting approval from the United States Food & Drug Administration. Description of the drug; Treatment of non-small cell lung cancers (NSCLC); Clinical studies on the drug; Side effects.


Read the Article


Sorry, but this item is not currently available from your library.

Try another library?
Sign out of this library

Other Topics