Guidance for industry : how to comply with the Pediatric Research Equity Act

Additional Titles: How to comply with the Pediatric Research Equity Act
Published: Rockville, MD : U.S. Dept. of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research : Center for Biologics Evaluation and Research, [2005]
Physical Description: 18 pages : digital, PDF file
Additional Creators: Center for Biologics Evaluation and Research (U.S.)

Access Online

purl.fdlp.gov

Availability

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Restrictions on Access

Free-to-read Unrestricted online access

Report Numbers

HE 20.4702:P 34

Subject(s)

Note

Title from PDF title page (viewed on June 4, 2009).
"Draft guidance".
"Procedural".
"September 2005".

Technical Details

Mode of access: Internet at the FDA web site. Address as of 6/4/09: http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM079756.pdf ; current access is available via PURL.

Action Note

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