Drugs

Methodological Considerations in Evaluation of Cancer as an Adverse Outcome Associated With Use of Non-Oncological Drugs and Biological Products in the Postapproval Setting; Public Meeting; Request for Comments

The Food and Drug Administration (FDA), in collaboration with the National Cancer Institute (NCI), is announcing a public meeting entitled ‘‘Methodological Considerations in Evaluation of Cancer as an Adverse Outcome Associated With Use of Non-Oncological Drugs and Biological Products in the Postapproval Setting.’’ The purpose of the public meeting is to engage in constructive dialogue and information sharing among regulators, researchers, the pharmaceutical industry, public health agencies, health care providers, and the general public concerning challenges in designing and implementing postapproval studies to evaluate the risk of cancer associated with use of non-oncological drugs and biological products. The input from this meeting and public docket will be used to inform the Agency on best study design and methodological options to consider when evaluating cancer risk in the postapproval setting.

Date(s) and Time(s):September 10, 2014 - 8:00 a.m. to 5:00 pm
September 11, 2014 - 8:00 a.m. to 5:00 pm
Location:The DoubleTree by Hilton Hotel
Washington DC—Silver Spring
The Pinnacle Grand Ballroom
8727 Colesville Road
Silver Spring, MD 20910
Tel: 301-589-5200
http://doubletree3.hilton.com/en/index.html
(Metro: Silver Spring Station on the Red Line)

Information on transportation, directions, and parking: DoubleTree Directions (PDF - 61KB)

Registration: Please register with Paul Tran at paul.tran@fda.hhs.gov by August 27, 2014

Registration is free and available on a first-come, first-served basis. If you need special accommodations due to a disability, please contact Paul Tran by September 3, 2014. Those without Internet access should contact Paul Tran at 301-796-9029 to register.

Requests for Oral Presentations for Open Public Comment:

If you would like to present at the meeting on topics related to challenges in designing and implementing postapproval studies to evaluate the risk of cancer associated with use of non-oncological drugs and biological products, please identify during registration the topic(s) you will address (see section II of the Federal Register Notice). FDA will do its best to accommodate requests to speak. FDA urges individuals and organizations with common interests to coordinate and give a joint, consolidated presentation. Following the close of registration, FDA will allot time for each presentation and notify presenters by September 3, 2014.

Written Comments:

FDA is soliciting from interested persons electronic or written comments on all aspects of the meeting topics through October 9, 2014. Attendees and non-attendees may submit electronic comments to http://www.regulations.gov. Submit written comments to the Division of Dockets Management (HFA–305), Food and Drug Administration, 5630 Fishers Lane, Rm.1061, Rockville, MD 20852. Please include the Docket No. FDA-2014-N-0731 in your written comment/submission. More details are in the attached Federal Register Notice.

For questions related to registration, oral presentations, scientific content, and other meeting logistics:

Please contact Paul Tran at paul.tran@fda.hhs.gov or by telephone at 301-796-9029

 

Page Last Updated: 11/14/2014
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