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Module XVIII - New FDA Actions II
INTRODUCTION
Welcome to the American Association of Poison
Control Center’s electronic continuing education program for Specialists
in Poison Information. This fourteen-day module will provide a review
of new Food and Drug Administration (FDA) actions including product label
changes, drug withdrawals, and newly approved agents. Additionally,
emphasis will be placed on reporting and monitoring of adverse drug reactions.
Questions in this module are derived from Internet versions of press releases,
Internet versions of FDA Talk Papers, and other resources that are widely
available to most Specialists in Poison Information.
release date - 5/25/99
most recent review date - 5/25/99
LEARNING OBJECTIVES
Upon completion of this electronic continuing education module, the participant will be able to:
1. Describe the clinical relevance of press releases and FDA communications concerning newly approved agents.
2. Discuss the rationale for product labeling changes.
3. Apply knowledge of new FDA actions to clinical scenarios.
4. Recognize the importance of monitoring
and reporting adverse drug reactions.
AUTHOR
Peter Ciancaglini, PharmD
REVIEW PANEL
Daniel Cobaugh, PharmD
Prashant Joshi, MD
Ruth Lawrence, MD
Christine Stork, PharmD
Paul Wax, MD
AUTHOR DECLARATION INFORMATION
As an accredited CME sponsor, the University of
Rochester Office of Continuing Professional Education requires that its
authors comply with ACCME Standards for Commercial Support of CME.
All authors are required to disclose any significant financial interest
or relationship that they may have with a supporting company or the manufacturer(s)
of any commercial product/service that will be discussed in the materials
they present.
ACCME STANDARDS OF COMMERCIAL SUPPORT OF CME
These standards require that materials be free
of commercial bias and that any information regarding commercial products/services
be based on scientific methods generally accepted by the medical community.
When discussing therapeutic options, it is our preference that only generic
names be used. If it is necessary to use a trade name, then those
of several companies must be used. Further, should the presentation
include discussion of any unlabelled or investigational use of a commercial
product, the author required to disclose this to the reader.
AUTHOR DECLARATIONS
NO DISCLOSURES have been made by the author(s)
of this module that could be perceived as a real or apparent conflict of
interest in the context of the subject of their presentation(s).
CERTIFICATION
The University of Rochester School of Medicine and Dentistry is accredited by the Accreditation Council for Continuing Medical Education to sponsor continuing medical education for physicians.
The University of Rochester School of Medicine and Dentistry designates this educational activity for a maximum of 3.0 hours in Category 1 credit towards the AMA Physician's Recognition Award. Each physician should claim only those hours of credit that he/she actually spent in the educational activity.
This CME activity was planned and
produced in accordance with the Essentials and Standards of the Accreditation
Council for Continuing Medical Education.