Guidance for industry and FDA staff : submission and resolution of formal disputes regarding the timeliness of premarket review of a combination product.

Guidance for industry and FDA staff : submission and resolution of formal disputes regarding the timeliness of premarket review of a combination product.

Bibliographic Details
Corporate Authors: United States. Food and Drug Administration. Office of Combination Products, Center for Biologics Evaluation and Research (U.S.)
Format: Government Document eBook
Language:English
Published: Rockville, MD : U.S. Dept. of Health and Human Services, Food and Drug Administration, Office of Combination Products, [2004?]
Subjects:
Dispute resolution (Law)
Drug approval > Government policy > United States.
Chemotherapy, Combination.
Online Access:https://purl.fdlp.gov/GPO/LPS114925
Description
Item Description:Title from PDF title page (viewed on July 16, 2009).
"05/2004"--Online title index.
Electronic resource.
Physical Description:7 pages : digital, PDF file.
Format:Mode of access: Internet at the FDA web site. Address as of 7/16/09: http://www.fda.gov/downloads/RegulatoryInformation/Guidances/UCM147126.pdf ; current access is available via PURL.