Guidance for industry : M4Q, the CTD, quality

Additional Titles:: M4Q, the CTD, quality
Published:: Rockville, MD : U.S. Dept. of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research, [2001]
Physical Description:: 29 pages : digital, PDF file
Additional Creators:: Center for Drug Evaluation and Research (U.S.) and International Conference on Harmonisation

Access Online

purl.fdlp.gov

Availability

Finding items...

Restrictions on Access:

Free-to-read Unrestricted online access

Report Numbers:

HE 20.4702:C 73/4

Subject(s):

Drugs—United States—Quality control—Government policy
Drug approval—Government policy—United States
Clinical trials—Reporting—Government policy—United States

Note:

Title from PDF title page (viewed on July 6, 2009).
"ICH".
"August 2001".

Technical Details:

Mode of access: Internet at the FDA web site. Address as of 7/6/09: http://www.fda.gov/downloads/RegulatoryInformation/Guidances/UCM129904.pdf ; current access is available via PURL.

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