[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