FDA Workshop
Structured Product Labeling Content of Labeling and Electronic Drug Establishment Registration and Drug Listing for the Biologics Industry
November 17, 2008
8:30 a.m. to 4 p.m.
Workshop Goals and Objectives
The Food and Drug Administration (FDA) is announcing a public workshop entitled ‘‘Structured Product Labeling (SPL) Content of Labeling and Electronic Drug Establishment Registration and Drug Listing for the Biologics Industry.’’ The purpose of the public workshop is to provide the biologics industry with guidance on submitting to FDA content of labeling in SPL format, present an overview of FDA’s voluntary pilot program for electronic submission of drug establishment registration and drug listing information under the regulations, and exhibit vendor SPL authoring tools that may be used in the creation and manipulation of SPL content of labeling.
This public workshop will feature presentations by FDA experts on SPL content of labeling and electronic drug establishment registration and drug listing. In addition, registrants will have access to a vendor exhibition of SPL authoring tools.
Location
Universities at Shady Grove,
Multipurpose Room, Building II,
9630 Gudelsky Dr.,
Rockville, MD 20850
Registration
Mail, FAX, or e-mail your registration information (including name, title, firm name, address, telephone and fax numbers) to the contact person by October 30, 2008. There is no registration fee for the public workshop. Early registration is recommended because seating is limited. Registration on the day of the public workshop will be provided on a space available basis beginning at 8 a.m.
Vendor Registration: Vendors wishing to exhibit their SPL authoring tools at this public workshop must register and submit their registration information (including name, title, firm name, address, telephone and fax numbers) to the contact person by October 30, 2008, via e-mail to spl@fda.hhs.gov.
Special accommodations
If you need special accommodations due to a disability, please contact Donna Lipscomb (see Contact Person) at least 7 days in advance.
For Program Information Contact
Donna Lipscomb,
Center for Biologics Evaluation and Research (HFM–43),
Food and Drug Administration,
1401 Rockville Pike, suite, 200N,
Rockville, MD 20852–1448,
301–827–2000,
FAX: 301–827–3079;
e-mail: spl@fda.hhs.gov (Subject line: CBER SPL Public Workshop)