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From: E-mailNewsService <biomednews@aol.com>
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Subject: BMN PRESS RELEASE: DIA Springs Ahead With 2 FDA Co-Sponsored
Workshops in May
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DIA SPRINGS AHEAD WITH 2 FDA CO-SPONSORED WORKSHOPS IN MAY
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HORSHAM PA USA -- MEDICAL INDUSTRY E-MAIL NEWS SERVICE(TM) -- MAY 04 2005 -- The Drug Information Association (DIA), a nonprofit organization serving the pharmaceutical and related industries, will begin May with 2 workshops: FDA/DIA Cross-labeling Workshop: Combination Products and Mutually Conforming Labeling; and Critical Path Opportunities: Use of Medical Imaging as a Drug Development Tool. Both workshops will be held in conjunction with the FDA.
The FDA/DIA Cross-labeling Workshop: Combination Products & Mutually Conforming Labeling will take place at the Marriott Bethesda North Hotel, Bethesda MD on May 10. The FDA is currently evaluating regulatory approaches to the mutually conforming labeling issue and wants stakeholder input.
THIS WORKSHOP WILL PROVIDE AN INTERACTIVE FORUM TO EXPLORE & DISCUSS THESE TOPICS:
-- Cross labeling and how it relates to the regulation of combination products consisting of 2 independently approved, manufactured and distributed products
-- Public health concerns if the labeling of 2 products does not conform and possible methods of resolving those concerns
-- Legal issues that arise if the labeling of 2 products does not conform and possible methods of resolving those issues
FDA REQUESTS PUBLIC COMMENTS:
Additionally, the FDA is opening this meeting for public comments. Attendees will have the opportunity to make a statement about legal and public heath issues related to cross labeling and participate in a panel discussion led by FDA representatives.
For more information, contact amanda.carmody@diahome.org or register online at:
Also at the Marriott Bethesda North Hotel, Critical Path Opportunities: Use of Medical Imaging as a Drug Development Tool, will be held on May 5-6. This workshop will begin with a discussion of the regulatory and scientific context for imaging, including its potential roles in the transition from preclinical to clinical drug development. Breakout sessions are planned for discussion of tracers and contrast agents, as well as hardware and software issues.
SPEAKERS:
Speakers for the program will also discuss the FDA's draft guidance, "Exploratory IND Studies." The guidance clarifies existing regulations and explains what preclinical and clinical issues drug developers and sponsors should consider when planning exploratory studies in humans, including studies of closely related drugs or biologics, under an exploratory investigational new drug (IND) application.
For more information, contact jolene.mcneil@diahome.org or register online at:
With more than 22,000 members worldwide, the Drug Information Association (DIA) is the premier member-driven organization encompassing the full continuum of disciplines in the pharmaceutical and related industries. DIA's mission is to serve and develop members by providing a neutral, global forum that promotes the exchange of information critical to professional performance and achievement.
FOR FURTHER INFORMATION, PLEASE CONTACT:
Drug Information Association
Main Desk Receptionist
800 Enterprise Rd Ste 200
Horsham PA USA 19044-3595
215-442-6100 phone
215-442-6199 fax
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Please forward this press release to colleagues who may want to read it.
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Drug Information Association
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