Subpart F–Confidentiality of Information
Sec. 601.50
Confidentiality of data and information in an investigational new drug notice for a biological product
(a) The existence of an IND notice for a biological product will not be disclosed by the Food and Drug Administration unless it has previously been publicly disclosed or acknowledged
“The Skeptics™” #FAIL
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REFERENCES:
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[1] – Les Rose (@Majikthyse) tweeted at 2:21pm – 25 Sep 13:
@dianthusmed @cappsie Hmm…FDA refused my request, saying all info subject to IND is confidential. We shall see! #Burzynski
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[2] – Code of Federal Regulations
Title 21, Volume 7
Revised as of April.1, 2013
TITLE 21–FOOD AND DRUGS
CHAPTER I–FOOD AND DRUG ADMINISTRATION
DEPARTMENT OF HEALTH AND HUMAN SERVICES
SUBCHAPTER F–BIOLOGICS
PART 601 LICENSING
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http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?CFRPart=601&showFR=1&subpartNode=21:7.0.1.1.2.6
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