Guideline

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21 CFR Part 314 Applications for FDA approval to market a new drug
Short Title:	21 CFR Part 314
Internet:	http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?CFRPart=314&showFR=1
Origin/Publisher:	FDA
Content:	This part sets forth procedures and requirements for the submission to, and the review by, the FDA of applications (including ANDA`s, supplements and postmarketing reports).
Document Type:	Code of Federal Regulations