[Federal Register Volume 60, Number 220 (Wednesday, November 15, 1995)]
[Notices]
[Pages 57434-57435]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 95-28148]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Regulatory Policy Issues in the Development and Manufacture of
Biopharmaceuticals and Other Biotechnology Derived Products; Notice of
Public Workshops
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice of public workshops.
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SUMMARY: The Food and Drug Administration (FDA) (Office of Regulatory
Affairs, Office of the Northeast and Mid-Atlantic Regions, Center for
Biologics Evaluation and Research, Center for Drug Evaluation and
Research, and Office of External Affairs) is announcing two free public
workshops to assist small companies that are developing and producing
biopharmaceutical and biologic therapeutic products for clinical trials
and product marketing approval. The workshops will address regulatory
policy issues, licensing requirements, cooperative manufacturing
arrangements, multiproduct facilities, clinical trial design, and
manufacturing requirements for clinical material. These workshops are a
continuance of the grassroots partnering approach with front line
regulators and the people affected by the work of this agency.
DATES: The public workshops are scheduled as follows:
1. Tuesday, November 28, 1995, 8 a.m. to 5 p.m., Baltimore, MD.
2. Thursday, November 30, 1995, 8:30 a.m. to 5 p.m., Woburn, MA.
[[Page 57435]]
ADDRESSES: The public workshops will be held at the following
locations:
1. Baltimore Marriott Inner Harbor, 110 South Eutaw St., Baltimore, MD.
2. Crown Plaza Boston/Woburn, 2 Forbes Rd., Woburn, MA.
FOR FURTHER INFORMATION CONTACT:
Regarding registration for the Baltimore public workshop: Jo Ann
Maquire, Regional Training Specialist, Mid-Atlantic Region, Food and
Drug Administration, 900 U.S. Customhouse, 2d & Chestnut Sts.,
Philadelphia, PA 19106, 215-597-4390, ext. 4004, or FAX 215-597-5798.
Regarding registration for the Woburn public workshop: Ellen
Madigan, Blood Bank Monitor, Northeast Region, Food and Drug
Administration, One Montvale Ave., Stoneham, MA 02180, 617-279-1675,
ext. 157 or FAX 617-279-1742.
Those persons interested in attending a workshop should register by
FAXing their name(s), firm name/affiliation, address, telephone and FAX
numbers, and any specific questions they want addressed at the workshop
to the information contact person listed above for each workshop. There
is no registration fee for these workshops, but advance registration is
required. Interested parties are encouraged to register early because
space is limited.
SUPPLEMENTARY INFORMATION: The purpose of these workshops is to further
assist small companies that are developing and producing
biopharmaceutical and biologic therapeutic products in better
understanding: Current regulatory policy; licensing requirements for
products and establishments and cooperative manufacturing arrangements;
multiproduct facilities design and operation; clinical trial design and
monitoring; points to consider during processing, cell culture,
fermentation, harvest, recovery, purification, and ascites production;
current good manufacturing practice requirements in the production of
clinical material; and recordkeeping, processing changes, and
environmental monitoring.
Dated: November 8, 1995.
William B. Schultz,
Deputy Commissioner for Policy.
[FR Doc. 95-28148 Filed 11-9-95; 9:54 am]
BILLING CODE 4160-01-F
