[Federal Register Volume 60, Number 206 (Wednesday, October 25, 1995)]
[Notices]
[Pages 54695-54696]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 95-26500]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Characterization of Biological/Biotechnology Pharmaceutical
Products; Notice of Public Workshop
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice of public workshop.
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SUMMARY: The Food and Drug Administration (FDA) is announcing a public
workshop on Characterization of Biological/Biotechnology Pharmaceutical
Products. The workshop will discuss the types of data that are
necessary to characterize biological/biotechnology pharmaceutical
products to assure their safety, identity, purity, potency, quality,
and consistency. Discussions will address the current abilities and
limitations of analytical technologies for characterization of
biotechnology products.
DATES: The public workshop, to include plenary and technical breakout
sessions, will be held on December 11, 12, and 13, 1995, from 8 a.m. to
5 p.m. Participants may pick up their information packages and badges
for admission to the sessions beginning each morning at approximately
7:30 a.m.
ADDRESSES: The public workshop will be held at the Omni Shoreham Hotel,
2500 Calvert St. NW., Washington, DC 20008. There is no registration
fee for this workshop, but advance registration is requested.
Interested parties are encouraged to register early because space is
limited.
FOR FURTHER INFORMATION CONTACT:
Regarding information on registration and other logistical matters
contact: Dawn Apple, KRA Corp., 1010 Wayne Ave., suite 850, Silver
Spring, MD 20910, 301-495-1591, or FAX 301-495-2919.
Regarding information on this document contact: Rosanna L. Harvey,
Center for Biologics Evaluation and Research (HFM-20), 1401 Rockville
Pike, Rockville, MD 20852-1448, 301-827-0377, or FAX 301-827-0440.
SUPPLEMENTARY INFORMATION: FDA recognizes that there have been
technology developments in process
[[Page 54696]]
control and new methodologies that can be applied to product
characterization and is interested in exploring with the public and
industry whether biological/biotechnology pharmaceutical products can
be well characterized. FDA intends to develop a definition for well
characterized biological/biotechnology pharmaceutical products
manufactured using biotechnology.
The goals of this meeting are to: (1) Discuss those analytical
techniques, process validations, and parameters that are critical in
the characterization of biological/biotechnology pharmaceutical
products to assure safety, identity, purity, potency, quality, and
consistency; and (2) develop a functional definition for well
characterized biological/biotechnology pharmaceutical products. The
information generated at the workshop may be used by FDA in developing
future scientific and regulatory policies.
Dated: October 20, 1995.
William B. Schultz,
Deputy Commissioner for Policy.
[FR Doc. 95-26500 Filed 10-24-95; 8:45 am]
BILLING CODE 4160-01-F
