[Federal Register: July 13, 2004 (Volume 69, Number 133)]
[Notices]
[Page 42060-42061]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr13jy04-68]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. 2004N-0279]
Developing Drug Information Association/Food and Drug
Administration Workshop: Pharmacogenomic Combination Product Co-
Development; Public Meeting
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice of public meeting; request for comments.
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SUMMARY: The Food and Drug Administration (FDA), in cooperation with
the Drug Information Association (DIA), is announcing a public meeting
to solicit views and to provide an interactive forum for discussion of
industry and other perspectives and experience derived from the
development of recently approved pharmacogenomic combination products.
The input received at the meeting, comments received during the
meeting, and comments made to the docket after the meeting, may be
considered in developing a draft guidance on this topic.
DATES: The public meeting will be held on July 29, 2004, from 8 a.m. to
5:30 p.m. Attendees must register to attend. Submit written or
electronic requests to speak at the public meeting by July 26, 2004.
Submit written or electronic comments before or after the meeting by
August 30, 2004.
ADDRESSES: The public meeting will be held at the Marriott Crystal
Gateway Hotel, 1700 Jefferson Davis Hwy., Arlington, VA. A copy of the
meeting's program is available on the Internet at http://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http://www.diahome.org/Content/Events/04040.pdf
.
Submit written comments to the Division of Dockets Management (HFA-
305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061,
Rockville, MD 20852. Submit electronic comments to http://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http://www.fda.gov/dockets/ecomments
.
FOR FURTHER INFORMATION CONTACT:
[[Page 42061]]
Those wishing to speak should contact: Allen Rudman, Office of Clinical
Pharmacology and Biopharmaceutics, Center for Drug Evaluation and
Research, 5600 Fishers Lane, Rockville, MD 20857, 301-827-7691, e-mail:
RUDMANA@CDER.FDA.GOV.
Those wishing to register for the meeting should contact: Drug
Information Association, P.O. Box 827192, Philadelphia, PA 19182-7192,
e-mail: DIA@DIAHOME.ORG.
SUPPLEMENTARY INFORMATION:
I. Background
FDA is embarking on a new initiative to develop guidance for the
codevelopment of pharmacogenomic-based therapeutic drug and biological
products and the diagnostic tests that are necessary for therapeutic
decision making. A number of diagnostic tests could be developed for
use with drug or biological products including, for example, tests
related to treatment decisions, such as whether patients should be
treated, the dose used for treatment, or to identify the risks
associated with treatment. FDA expects to develop guidance for the
codevelopment of therapeutic and diagnostic products where both will be
necessary in the clinical management of patients.
In preparation for drafting the guidance, FDA and DIA have planned
a 1-day mini-meeting, in collaboration with Pharmaceutical Research and
Manufacturers of America, Biotechnology Industry Organization, Advanced
Medical Technology Association, Medical Device Manufacturers
Association, the DIA Biotechnology Special Interest Action Committee,
and the Pharmacogenomics Working Group, to identify important issues
related to the codevelopment of pharmacogenomic combination products.
FDA believes it is important to receive input from industry and other
interested parties through a public meeting before drafting the
guidance.
Previously, FDA and industry have cosponsored two multi-day
meetings on pharmacogenomics in May 2002 and November 2003,
respectively. This collaboration between industry, FDA, and other
interested parties has also facilitated the writing and issuance of the
draft guidance for industry entitled ``Pharmacogenomic Data
Submissions,'' which was issued in November 2003 and is currently being
finalized.
II. Goals of the Meeting
The primary intent of this mini-meeting is to provide an
interactive forum for discussing industry and other perspectives and
experience derived from the development of recently approved
pharmacogenomic combination products. This meeting is intended to be
highly interactive, identify issues, and address questions that will
provide FDA with valuable information to consider during development of
guidance for industry on the codevelopment of pharmacogenomic
combination products for therapeutic and diagnostic use.
Key areas identified for particular focus include the following:
Industry vision of an ideal codevelopment process and
regulatory framework,
Clinical trial design and statistical challenges for the
codevelopment of therapeutic and diagnostic pharmacogenomic products,
Case studies to explore detailed considerations for the
analytical validation of pharmacogenomic diagnostic products, and
Clinical utility of pharmacogenomic diagnostic products.
Specific goals of the meeting include the following:
1. Provide greater awareness and understanding of the regulatory
and scientific challenges of codeveloping pharmacogenomic combination
products.
2. Obtain greater clarity on the clinical and statistical design
issues that affect the codevelopment of drug and pharmacogenomic
combination products.
3. Provide an opportunity to help define the elements that are
needed in guidance for industry to enhance the codevelopment of
pharmaogenomic combination products.
4. Provide pharmaceutical, biological product, device industries,
and other public stakeholders with an opportunity to identify issues
and propose recommendations for FDA consideration as it develops formal
guidance on the codevelopment of pharmaogenomic combination products.
III. Intended Audience
This meeting is intended for developers and potential developers of
therapeutic drug and biological products and pharmacogenomic-based
diagnostic products to be developed and approved with them as
combination products. Other interested persons may include regulatory/
clinical decision-makers, designers of clinical and laboratory
validation protocols, clinical pharmacologists, physicians,
biostatisticians, and geneticists working in industry or academia.
IV. Request for Comments
Regardless of attendance at the meeting, interested persons may
submit to the Division of Dockets Management (see ADDRESSES) written or
electronic comments on the topics presented in this document. The
agency welcomes comments before and after the meeting. Two paper copies
of mailed comments are to be submitted, except that individuals may
submit one paper copy. Comments are to be identified with the docket
number found in brackets in the heading of this document. Received
comments are available for public examination in the Division of
Dockets Management between 9 a.m. and 4 p.m., Monday through Friday.
Dated: July 8, 2004.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. 04-15935 Filed 7-9-04; 2:24 pm]
BILLING CODE 4160-01-S