[Federal Register: June 5, 2003 (Volume 68, Number 108)]
[Notices]
[Page 33723-33724]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr05jn03-87]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. 03N-0203]
Innovative Systems for Delivery of Drugs and Biologics:
Scientific, Clinical, and Regulatory Challenges Public Workshop
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice of public workshop and request for comments.
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SUMMARY: The Food and Drug Administration (FDA) is announcing a public
workshop to discuss innovative systems for delivery of drugs and
biologics. The purpose of this workshop is to serve as a forum for the
academic and clinical communities, industry, consumer and patient
advocacy groups, and FDA to discuss the latest scientific and clinical
developments for these products, as well as any regulatory concerns and
challenges. FDA hopes to facilitate the development of new technology
by addressing and clarifying regulatory uncertainty and by increasing
the predictability of product development. This project is a part of
the Commissioner of the Food and Drug Administration's initiative
entitled ``Improving Innovation in Medical Technology: Beyond 2002.''
For reference, the white paper describing the entire initiative is
available at http://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http://www.fda.gov/bbs/topics/NEWS/2003/NEW00867.html. The
input received at the workshop and from written comments will be
considered in drafting guidance or other information for industry.
Date and Time: The public workshop will be held on July 8, 2003,
from 8 a.m. to 5:30 p.m.
Addresses: The public workshop will be held at the Bethesda
Marriott, 5151 Pooks Hill Rd., Bethesda, MD 20814, 301-897-9400, FAX
301-897-0192. Submit written or electronic comments to the Dockets
Management Branch (HFA-305), Food and Drug Administration, 5630 Fishers
Lane, rm. 1061, Rockville, MD 20852, e-mail: FDADockets@oc.fda.gov.
Additional information about the meeting and directions to the facility
are available on the Internet at: http://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http://www.fda.gov/cdrh/meetings/070803.html
.
Contact Person: Cynthia Benson, Center for Devices and Radiological
Health (HFZ-3), Food and Drug Administration, 9200 Corporate Blvd.,
Rockville, MD 20850, 301-827-7989, e-mail: cmh@cdrh.fda.gov.
[[Page 33724]]
Agenda: At the workshop, FDA will hear presentations and receive
comments from stakeholders likely to be affected by FDA policies or
procedures regarding the review and approval of innovative medical
products. Stakeholders include, but are not limited to device, drug,
and biological product manufacturers; members of the academic and
clinical communities; and consumer and patient advocacy groups.
Registration: Preregistration is required by July 1, 2003, and will
be accepted on a first-come, first-served basis; however,
notwithstanding attendance at the workshop, interested persons are
encouraged to provide comments (see the Request for Comments section of
this document). There will be no onsite registration. FDA is pleased to
provide the opportunity for interested persons to listen from a remote
location to the live proceedings of the public workshop. In order to
ensure that a sufficient number of call-in lines are available, please
register to listen to the meeting at http://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http://www.fda.gov/cdrh/meetings/070803.html.
Persons without Internet access may call 1-888-203-6161.
The registration deadline is July 1, 2003. For technical reasons,
persons wishing to make an oral presentation at the public workshop
must do so in person. Those who wish to make presentations should
submit written notification including: (1) The specific issue related
to the topic you intend to address; (2) the names and addresses of all
individuals that will participate in your presentation; (3) the
approximate amount of time your presentation will require; and (4) two
copies of all presentation materials to Cynthia Benson by June 27,
2003. Presentations will be limited to the topics outlined in the
SUPPLEMENTARY INFORMATION section of this document and, depending on
the number of speakers, FDA may limit the time allotted for each
presentation. If you need special accommodations due to a disability,
please contact Anne Marie Williams at 301-594-1283 at least 7 days in
advance.
Request for Comments: Regardless of attendance at the workshop,
interested persons may submit written or electronic comments to the
Dockets Management Branch (see the Addresses section of this document).
You should annotate and organize your comments to identify the specific
issues to which they refer. Submit two paper copies of any mailed
comments. Individuals may submit one copy. Identify comments with the
docket number found in brackets in the heading of this document. The
comments that FDA receives will be made available at the Dockets
Management Branch between 9 a.m. and 4 p.m., Monday through Friday.
Transcripts: Following the workshop, transcripts will be available
for review at the Dockets Management Branch (see the Addresses section
of this document).
SUPPLEMENTARY INFORMATION: FDA believes that innovative and novel
medical technologies have the potential to greatly improve the public
health in many different areas. By addressing and clarifying regulatory
uncertainty, the agency believes that the development of these
technologies will be expedited and the predictability in product
development will be increased, thus allowing more of these products to
reach the marketplace in a timely manner. As part of a broad effort to
increase the development of novel medical technologies, FDA is seeking
information on how to expedite the review and approval of innovative
devices for the delivery of drugs and biologics. For this effort, these
products will be broadly defined. We are including any combination of
drug and device or biologic and device products in which the two
components work together to have a desired effect on the patient. Some
examples of the innovative products to be included in this effort are:
[sbull] Novel, specialized catheters to permit localized delivery
of drugs or biologics (e.g., chemotherapeutic agents, thrombolytics,
cells/biologics);
[sbull] Lasers or other energy delivery devices for delivery or
enhancement of drug or biologic effectiveness (e.g., electroporetic or
laser systems to enhance the transport of drugs to the target site);
[sbull] Device/drug or device/biologic combinations that permit new
routes of administration for drugs (e.g., devices for inhalation of
drugs formerly administered intravenously);
[sbull] Devices that activate drugs in the body (e.g., photodynamic
therapy);
[sbull] Drug-eluting stents designed to prevent restenosis; and
[sbull] Orthopedic repair products containing bone morphogenic
proteins or other cytokines.
The lead for review of the products to be discussed in the workshop
may be in any of the FDA medical products centers (the Center for Drug
Evaluation and Research, the Center for Biologics Evaluation and
Research, and the Center for Devices and Radiological Health, i.e.,
CDER, CBER or CDRH) and the products may reach the market through
several different regulatory pathways (e.g., investigational device
exemption/premarket approval applications (IDE/PMA), investigational
new drug application/new drug application (IND/NDA), IND/biological
license application (BLA), IDE/510(k), or a combination of these). This
workshop is being held to provide a forum for the academic and clinical
communities, industry, consumer and patient advocacy groups and FDA to
discuss the latest scientific and clinical developments for these
products as well as any regulatory concerns and challenges. In addition
to increasing our understanding of the latest technological
developments in this field, FDA is seeking input to specifically
address the following:
1. What are the most critical challenges in developing and bringing
to market a novel, innovative technology for delivery of drugs or
biologics?
2. Which areas are most important for the agency to provide
guidance to developers of these novel products?
3. How can the agency best collaborate with industry, academia,
other government agencies, and other scientific bodies in this area of
rapidly evolving technology?
The agency hopes to use the information from the workshop to guide
the future development of guidance documents, memoranda of
understanding, or other position papers.
Dated: May 27, 2003.
Linda S. Kahan,
Deputy Director, Center for Devices and Radiological Health.
[FR Doc. 03-14209 Filed 6-4-03; 8:45 am]
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