FDA Extends Date for
Public Comment on IVDMIA Guidance
The FDA
has extended the public comment period on the IVDMIA to March 5, 2007. Research Advocacy Network has conducted two
informational webconferences to update advocates about the issues surrounding
this draft guidance in preparation for comments.
The
speakers on the webconferences were:
-
Steven I. Gutman, MD, Director, Office of In Vitro Diagnostic (OIVD)
Device
Evaluation and Safety, Center for Devices and Radiological Health
- Paul Radensky, MD, JD, Partner, McDermott, Will and Emery
- Bob Erwin, Patient Advocate, Founder and President, Marti Nelson Cancer
Foundation
The links to
the replays are:
October
30th Briefing Playback http://playback.claripoint.com/play/30013525
November
2nd Briefing Playback: http://playback.claripoint.com/play/30014417
Other
information that may be helpful as you consider your response:
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Nanotechnology in
Cancer Research
The NCI
Alliance for Nanotechnology in Cancer is a comprehensive, systematized
initiative encompassing the public and private sectors, designed to accelerate
the application of the best capabilities of nanotechnology to cancer.
Currently,
scientists are limited in their ability to turn promising molecular discoveries
into benefits for cancer patients. Nanotechnology can provide the technical
power and tools that will enable those developing new diagnostics,
therapeutics, and preventives to keep pace with today's explosion in knowledge.
Nanotechnology
is making major inroads in advancing cancer research. For more information about the latest
announcements go to http://nano.cancer.gov/.
Topics from Nanotech News, November
20th include:
Issues and
concerns about the technology was a recent topic of a publication in the
journal, Nature. In the article, Chief Science Officer, Project on Emerging Nanotechnology Woodrow Wilson
Center, Dr Andrew D. Maynard
and his co-authors discuss the pursuit of responsible nanotechnologies.
To link
to the full article or to review a webcast of the public event to discuss these
issues please go to: http://www.nanotechproject.org/95/111606-scientists-set-five-grand-challenges-for-nanotechnology-risk-research
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FDA
Approves Silicone Gel-Filled Breast Implants After In-Depth Evaluation
After
rigorous scientific review, the U.S. Food and Drug Administration (FDA) has approved
the marketing of silicone gel-filled breast implants for breast reconstruction
in women of all ages and breast augmentation in women ages 22 and older.
The products are manufactured by Allergan Corp. (formerly Inamed Corp.), Irvine, Calif., and
Mentor Corp., Santa Barbara,
Calif.
"FDA
has reviewed an extensive amount of data from clinical trials of women studied
for up to four years, as well as a wealth of other information to determine the
benefits and risks of these products," said Daniel Schultz, M.D., Director,
Center for Devices and Radiological Health, FDA. "The extensive body of
scientific evidence provides reasonable assurance of the benefits and risks of
these devices. This information is available in the product labeling and
will enable women and their physicians to make informed decisions."
In
the past decade, a number of independent studies have examined whether silicone
gel-filled breast implants are associated with connective tissue disease or
cancer. The studies, including a report by the Institute of Medicine,
have concluded there is no convincing evidence that breast implants are
associated with either of these diseases. However, these issues will be
addressed further in the postapproval studies conducted by the companies.
FDA
approved the silicone gel-filled breast implants with a number of conditions,
including requiring each company to: conduct a large postapproval study;
continue its core study through 10 years; conduct a focus group study of the
patient labeling; continue laboratory studies to further characterize types of
device failure; and track each implant in the event, for example, that health
professionals and patients need to be notified of updated product information.
The
postapproval studies will continue to gather information about the safety and
effectiveness of the implants. Information will be collected about rates
of local complications, rates of connective tissue disease and its signs and
symptoms, rates of neurological disease and its signs and symptoms, potential
effects on offspring of women with breast implants, potential effects on
reproduction and lactation, rates of cancer, rates of suicide, potential
interference of breast implants with mammography, and MRI compliance and
rupture rates.
The
postapproval studies will be closely monitored by FDA. FDA anticipates
that data from the studies will provide important information for patients and
physicians, and may lead to improvements in device labeling.
From
the FDA website http://www.fda.gov/bbs/topics/NEWS/2006/NEW01512.html.
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RAN Co-Founder Changes Role
Judy Perotti Semi-Retires
We wish
to express our sincere gratitude to Judy Perotti as she leaves Research
Advocacy Network board and leadership.
Judy was one of the original co-founders of Research Advocacy Network. She is a talented writer and a strong
advocacy voice. She hopes to continue her
advocacy work as she "semi" retires with her husband, Bob. For more information about her plans please
see her at the San Antonio Breast Cancer Symposium or contact her via email at japero@ameritech.net. Our best wishes to Judy!
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Alamo Breast Cancer Foundation Hot Topics
2006
Each year
the Alamo Breast Cancer Foundation sponsors a mentor program at the San Antonio
Breast Cancer Symposium. Following the
symposium (after approximately 3 months) they publish a Hot Topics
publication/CD from the year's symposium.
For more information go to http://www.m3login.com/Content/E99FDD09-0391-4793-B2A2-A227AE1DD322/.
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Research
Advocacy
Network Activities
- Nov 7 -8 - Summit on Cancer Clinical Trials
- Nov 14 - PRIM&R Community Member Training
- Nov 15- 17 PRIM&R Annual Meeting
- Nov 28 - 29 caBIG Data Sharing and Intellectual Capital
Meeting
- Dec 14-17 San Antonio Breast Cancer Symposium
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We need your help! Your Donation Makes a Difference!
If you believe in the hope of research and the power of advocacy, you can help
the Research Advocacy Network (RAN) by sending a donation. RAN is an exempt 501 c 3
organization and dependent on your support to keep going.
PLEASE NOTE our new mailing
address is: 6505 W. Park Blvd,
Suite 306, PMB 200, Plano, TX 75093.
Thanks!
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Research
Advocacy Network Welcomes
New Members!!! Thanks to all of you who have recently joined the Network.
For those that have not yet please go to http://www.researchadvocacy.org/
and click on "Join" There are no dues for Network membership and this
will assure that you receive all notices and have access to Network programs.
Editor: Elda
Railey
Network News is currently published 10 times per year and
includes articles on advocacy, research results and activities. Please
share Network News with your friends with the link above. Research Advocacy
Network is an Illinois
not-for-profit corporation and is designated as an exempt 501 c 3 organization
by the IRS. Your donations are greatly appreciated and tax deductible to the
extent allowed by law.
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