Research Catalog

Details

Additional authors

1. United States. Food and Drug Administration.

Description

1. i, 9 pages : digital, PDF file

Alternative title

1. Process for handling referrals to FDA under 21 CFR 50.54
2. Additional safeguards for children in clinical investigations

Subject

1. Medical research personnel > Government policy > United States
2. Clinical trials > Government policy > United States
3. Pediatrics > Research > Government policy > United States

Call number

1. GPO Internet HE 20.4002:R 25/2

Note

1. Title from PDF title page (viewed on May 12, 2009).
2. "December 2006".

System details (note)

1. Mode of access: Internet at the FDA CBER web site. Address as of 5/12/09: http://www.fda.gov/cber/gdlns/childclininv.pdf ; current access is available via PURL.

Title

1. Guidance for clinical investigators, institutional review boards, and sponsors : process for handling referrals to FDA under 21 CFR 50.54 : additional safeguards for children in clinical investigations.

Publisher

1. Rockville, MD : U.S. Dept. of Health and Human Services, Food and Drug Administration, [2006]

Type of content

1. text

Type of medium

1. computer

Type of carrier

1. online resource

System details

1. Mode of access: Internet at the FDA CBER web site. Address as of 5/12/09: http://www.fda.gov/cber/gdlns/childclininv.pdf ; current access is available via PURL.

Connect to:

1. https://purl.fdlp.gov/GPO/LPS112485

Added author

1. United States. Food and Drug Administration.

Gpo item no.

1. 0475 (online)

Sudoc no.

1. HE 20.4002:R 25/2