[Federal Register Volume 62, Number 167 (Thursday, August 28, 1997)]
[Notices]
[Pages 45670-45671]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 97-22982]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
Potency and Dosage of Von Willebrand Factor Concentrates; Public
Workshop
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
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The Food and Drug Administration (FDA) is announcing a public
workshop entitled ``FDA Sponsored Workshop on Potency and Dosage of von
Willebrand Factor Concentrates (vWF).'' The topics to be discussed
include potency assays and standards for vWF concentrates;
pharmacokinetic studies and clinical trials of vWF concentrates; the
correlation of dosage regimens with clinical outcome; and labeling of
vWF concentrates.
Date and Time: The workshop will be held on September 26, 1997, 8
a.m. to 5 p.m.
Location: The workshop will be held at Jack Masur Auditorium,
National Institute of Health, 8800 Rockville Pike, Bldg. 10, Bethesda,
MD 20892.
Contact: Joseph Wilczek, Center for Biologics Evaluation and
Research (HFM-350), Food and Drug Administration, 1401 Rockville Pike,
Rockville, MD 20852-1448, 301-827-3514, FAX 301-827-2843.
SUPPLEMENTARY INFORMATION:
FDA has the responsibility of ensuring that product labeling
provides information about product potency and dosage. In the case of
replacement therapy for deficiencies in coagulation factor activity,
this has been done by assessing the potency of a product relative to a
defined standard, and by measuring the pharmacokinetics of the product.
This information has been used to establish a dosage that will raise
the concentration of circulating coagulation activity to a targeted
level for a known period of time. Clinical trials establish the
clinical benefit of a given dosage regimen. This model has been
difficult to apply to products submitted to FDA for licensure for the
treatment of vWF because there is no standardized in vitro test for vWF
potency; there is no vWF
[[Page 45671]]
concentrate standard, and assays based on vWF plasma standards may not
be appropriate to measure the potency of concentrates; and published
clinical trials have not correlated the dosage of specific products
with clinical outcome. The main goal of this workshop is to address
these concerns through exchange of information about each of these
issues, through the participation of the patient, industrial, medical,
scientific, and regulatory communities. Workshop participants are asked
to present their positions, rationales, and/or experiences regarding:
(1) The benefits and liabilities of using ristocetin cofactor activity,
or other tests, to measure vWF activity; (2) proposals for
standardizing the potency and dosage of vWF concentrates; and (3)
clinical trials to relate given dosage regimen to clinical benefit.
Information presented at this workshop will assist in product
development and facilitate licensure of safe and effective vWF
products.
Registration and Requests for Oral Presentations: Fax registration
information (including name, title, firm name, address, telephone, and
fax number), and written material and requests to make oral
presentations, to the contact person by September 19, 1997.
Registration at the site will be done on a space available basis on the
day of the workshop beginning at 7:30 a.m. There is no registration fee
for the workshop.
If you need special accommodations due to a disability, please
contact Joseph Wilczek at least 7 days in advance.
Transcripts: Transcripts of the workshop may be requested in
writing from the Freedom of Information Office (HFI-35), Food and Drug
Administration, rm. 12A-16, 5600 Fishers Lane, Rockville, MD 20857,
approximately 15 working days after the workshop at a cost of 10 cents
per page.
Dated: August 22, 1997.
William B. Schultz,
Deputy Commissioner for Policy.
[FR Doc. 97-22982 Filed 8-27-97; 8:45 am]
BILLING CODE 4160-01-F
