Guidance for industry
Subtitle: content and format of investigational new drug applications (INDs) for phase 1 studies of drugs, including well-characterized, therapeutic, biotechnology-derived products.
Contributors: Center for Drug Evaluation and Research (U.S.); Center for Biologics Evaluation and Research (U.S.)
Publisher: Center for Drug Evaluation and Research; Center for Biologics Evaluation and Research
Published: 1995
Place of publication: [Rockville, MD]
Language: eng
Format: Microform
Number of pages: 15
Subjects: Drugs -- Testing -- Government policy -- United States.; Pharmaceutical policy -- United States.
Notes: Cover title.

Distributed to depository libraries in microfiche.

Shipping list no.: 97-0840-M.

"November 1995."

"CLIN 2."

Includes bibliographical references (p. 14).

Also available via Internet from the CDER web site (PDF file only).

Microfiche. [Washington, D.C.?] : Supt. of Docs., U.S. G.P.O., [1997] 1 microfiche : negative.