Guidance for industry : content and format of investigational new drug applications (INDs) for phase 1 studies of drugs, including well-characterized, therapeutic, biotechnology-derived products.

Bibliographic Details
Corporate Authors:	Center for Drug Evaluation and Research (U.S.), Center for Biologics Evaluation and Research (U.S.)
Format:	Government Document Microform Book
Language:	English
Published:	[Rockville, Md.] : Center for Drug Evaluation and Research : Center for Biologics Evaluation and Research, [1995]
Subjects:	Drugs > Testing > Government policy > United States. Pharmaceutical policy > United States.
Online Access:	URL accesses index of CDER guidance documents, from which a link may be made to the title desired

Description
Item Description:	Cover title. Distributed to depository libraries in microfiche. Shipping list number: 97-0840-M. "November 1995." "CLIN 2." Microform.
Physical Description:	i, 15 leaves ; 28 cm. Also available via Internet from the CDER web site (PDF file only).
Bibliography:	Includes bibliographical references (page 14).