[Federal Register: June 5, 2003 (Volume 68, Number 108)]
[Page 33723-33724]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]



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.


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 
    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, 
    [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 
    [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 
    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]