|
|
|
|
He 20. 4702 :St 4
|
|
|
|
Guidance for industry [electronic resource] : aerosol steroid product safety information in prescript
HE 20.4702:ST 4
;
Axe Federal Documents Online:Available
|
|
1997
|
|
Guidance for industry [electronic resource] : aerosol steroid product safety information in prescript
Axe Federal Documents Online:Available
|
|
1997
|
|
|
He 20. 4702 :St 4/ 2
|
|
|
|
Guidance for industry for the submission documentation for sterilization process validation in applic
HE 20.4702:ST 4/2
;
Axe Federal Documents Online:Available
|
|
1994
|
|
Guidance for industry for the submission documentation for sterilization process validation in applic
Axe Federal Documents Online:Available
|
|
1994
|
|
|
He 20. 4702 :St 8
|
|
|
|
Guidance for industry [electronic resource] : street drug alternatives.
HE 20.4702:ST 8
;
Axe Federal Documents Online:Available
|
|
2000
|
|
Guidance for industry [electronic resource] : street drug alternatives.
Axe Federal Documents Online:Available
|
|
2000
|
|
|
He 20. 4702 :St 8/ 2/Draft
|
|
|
|
Guidance for industry [electronic resource] : SPL standard for content of labeling technical Qs & As.
HE 20.4702:ST 8/2/DRAFT
;
Axe Federal Documents Online:Available
|
|
2009
|
|
Guidance for industry [electronic resource] : SPL standard for content of labeling technical Qs & As.
Axe Federal Documents Online:Available
|
|
2009
|
|
|
He 20. 4702 :St 8/ 3
|
|
|
|
Structure and content of clinical study reports [electronic resource].
HE 20.4702:ST 8/3
;
Axe Federal Documents Online:Available
|
|
1996
|
|
Structure and content of clinical study reports [electronic resource].
Axe Federal Documents Online:Available
|
|
1996
|
|
|
He 20. 4702 :T 11
|
|
|
|
Guidance for industry [electronic resource] : Q3C tables and list.
HE 20.4702:T 11
;
Axe Federal Documents Online:Available
|
|
2003
|
|
Guidance for industry [electronic resource] : Q3C tables and list.
Axe Federal Documents Online:Available
|
|
2003
|
|
|
He 20. 4702 :T 11/ 2
|
|
|
|
Guidance for industry [electronic resource] : orally disintegrating tablets.
HE 20.4702:T 11/2
;
Axe Federal Documents Online:Available
|
|
2008
|
|
Guidance for industry [electronic resource] : orally disintegrating tablets.
Axe Federal Documents Online:Available
|
|
2008
|
|
|
He 20. 4702 :T 28
|
|
|
|
Guidance for industry [electronic resource] : Q6B specifications : test procedures and acceptance cri
HE 20.4702:T 28
;
Axe Federal Documents Online:Available
|
|
1999
|
|
Guidance for industry [electronic resource] : Q6B specifications : test procedures and acceptance cri
Axe Federal Documents Online:Available
|
|
1999
|
|
|
He 20. 4702 :T 28/ 2
|
|
|
|
Guidance for industry [electronic resource] : PAC-ATLS : postapproval changes, analytical testing la
HE 20.4702:T 28/2
;
Axe Federal Documents Online:Available
|
|
1998
|
|
Guidance for industry [electronic resource] : PAC-ATLS : postapproval changes, analytical testing la
Axe Federal Documents Online:Available
|
|
1998
|
|
|
He 20. 4702 :T 34
|
|
|
|
Guidance for industry [electronic resource] : available therapy.
HE 20.4702:T 34
;
Axe Federal Documents Online:Available
|
|
2004
|
|
Guidance for industry [electronic resource] : available therapy.
Axe Federal Documents Online:Available
|
|
2004
|
|
|
He 20. 4702 :T 62/Draft
|
|
|
|
Guidance for industry [electronic resource] : labeling guidance for OTC topical drug products for the
HE 20.4702:T 62/DRAFT
;
Axe Federal Documents Online:Available
|
|
1998
|
|
Guidance for industry [electronic resource] : labeling guidance for OTC topical drug products for the
Axe Federal Documents Online:Available
|
|
1998
|
|
|
He 20. 4702 :T 64
|
|
|
|
Guidance for industry and review staff [electronic resource] : recommended approaches to integration
HE 20.4702:T 64
;
Axe Federal Documents Online:Available
|
|
2006
|
|
Guidance for industry and review staff [electronic resource] : recommended approaches to integration
Axe Federal Documents Online:Available
|
|
2006
|
|
|
He 20. 4702 :T 64/ 2
|
|
|
|
Guidance for industry [electronic resource] : single dose acute toxicity testing for pharmaceuticals.
HE 20.4702:T 64/2
;
Axe Federal Documents Online:Available
|
|
1996
|
|
Guidance for industry [electronic resource] : single dose acute toxicity testing for pharmaceuticals.
Axe Federal Documents Online:Available
|
|
1996
|
|
|
He 20. 4702 :T 66
|
|
|
|
Guideline for industry [electronic resource] : detection of toxicity to reproduction for medicinal pr
HE 20.4702:T 66
;
Axe Federal Documents Online:Available
|
|
1996
|
|
Guideline for industry [electronic resource] : detection of toxicity to reproduction for medicinal pr
Axe Federal Documents Online:Available
|
|
1996
|
|
|
He 20. 4702 :Un 2/Draft
|
|
|
|
Guidance [electronic resource] : expiration dating of unit-dose repackaged drugs, compliance policy g
HE 20.4702:UN 2/DRAFT
;
Axe Federal Documents Online:Available
|
|
2005
|
|
Guidance [electronic resource] : expiration dating of unit-dose repackaged drugs, compliance policy g
Axe Federal Documents Online:Available
|
|
2005
|
|
|
He 20. 4702 :V 23
|
|
|
|
Guidance for industry [electronic resource] : Q2B validation of analytical procedures, methodology.
HE 20.4702:V 23
;
Axe Federal Documents Online:Available
|
|
1996
|
|
Guidance for industry [electronic resource] : Q2B validation of analytical procedures, methodology.
Axe Federal Documents Online:Available
|
|
1996
|
|
|
He 20. 4702 :V 42
|
|
|
|
Guidance for industry [electronic resource] : variations in drug products that may be included in a s
HE 20.4702:V 42
;
Axe Federal Documents Online:Available
|
|
1998
|
|
Guidance for industry [electronic resource] : variations in drug products that may be included in a s
Axe Federal Documents Online:Available
|
|
1998
|
|
|
He 20. 4702 :V 81
|
|
|
|
Guidance for industry [electronic resource] : Q5A viral safety evaluation of biotechnology products d
HE 20.4702:V 81
;
Axe Federal Documents Online:Available
|
|
1998
|
|
Guidance for industry [electronic resource] : Q5A viral safety evaluation of biotechnology products d
Axe Federal Documents Online:Available
|
|
1998
|
|
|
He 20. 4702 :W 24/Draft
|
|
|
|
Guidance for industry [electronic resource] : warnings and precautions, contraindications, and boxed
HE 20.4702:W 24/DRAFT
;
Axe Federal Documents Online:Available
|
|
2006
|
|
Guidance for industry [electronic resource] : warnings and precautions, contraindications, and boxed
Axe Federal Documents Online:Available
|
|
2006
|
|
|
He 20. 4708 :D 84
|
|
|
|
Guidance for industry [electronic resource] : national uniformity for nonprescription drugs : ingredi
HE 20.4708:D 84
;
Axe Federal Documents Online:Available
|
|
1998
|
|
Guidance for industry [electronic resource] : national uniformity for nonprescription drugs : ingredi
Axe Federal Documents Online:Available
|
|
1998
|
|
|
He 20. 4715 :
|
|
|
|
Orange book [electronic resource] : approved drug products with therapeutic equivalence evaluations.
HE 20.4715:
;
Axe Federal Documents Online:Available
|
|
1985
|
|
Approved drug products with therapeutic equivalence evaluations.
HE 20.4715:
;
Axe Federal Documents Online:Available
|
|
1985
|
|
Approved drug products with therapeutic equivalence evaluations.
Axe Federal Documents Online:Available
|
|
1985
|
|
Orange book [electronic resource] : approved drug products with therapeutic equivalence evaluations.
Axe Federal Documents Online:Available
|
|
1985
|
|
|
He 20. 4715/ 2 :
|
|
|
|
Approved drug products with therapeutic equivalence evaluations [electronic resource].
HE 20.4715/2:
;
Axe Federal Documents Online:Available
|
|
1985
|
|
Approved drug products with therapeutic equivalence evaluations [electronic resource].
Axe Federal Documents Online:Available
|
|
1985
|
|
|
He 20. 4801 :
|
|
|
|
Annual report [electronic resource]/ Center for Biologics Evaluation & Research.
HE 20.4801:
;
Axe Federal Documents Online:Available
|
|
19--
|
|
Annual report [electronic resource]/ Center for Biologics Evaluation & Research.
Axe Federal Documents Online:Available
|
|
19--
|
|
FY ... report from the director.
|
|
2012
|
|
|
He 20. 4802 :Al 5
|
|
|
|
Guidance for industry [electronic resource] : considerations for allogeneic pancreatic islet cell pro
HE 20.4802:AL 5
;
Axe Federal Documents Online:Available
|
|
2008
|
|
Guidance for industry [electronic resource] : considerations for allogeneic pancreatic islet cell pro
Axe Federal Documents Online:Available
|
|
2008
|
|
|
He 20. 4802 :An 1
|
|
|
|
Guidance for industry and FDA staff [electronic resource] : commercially distributed analyte specific
HE 20.4802:AN 1
;
Axe Federal Documents Online:Available
|
|
2007
|
|
Guidance for industry and FDA staff [electronic resource] : commercially distributed analyte specific
Axe Federal Documents Online:Available
|
|
2007
|
|
|
He 20. 4802 :An 5
|
|
|
|
Guidance for industry [electronic resource] : animal models : essential elements to address efficacy
HE 20.4802:AN 5
;
Axe Federal Documents Online:Available
|
|
2009
|
|
Guidance for industry [electronic resource] : animal models : essential elements to address efficacy
Axe Federal Documents Online:Available
|
|
2009
|
|
|
He 20. 4802 :An 5/ 2
|
|
|
|
Animal models [electronic resource] : essential elements to address efficacy under the animal rule.
HE 20.4802:AN 5/2
;
Axe Federal Documents Online:Available
|
|
2008
|
|
Animal models [electronic resource] : essential elements to address efficacy under the animal rule.
Axe Federal Documents Online:Available
|
|
2008
|
|
|
He 20. 4802 :An 5/ 3
|
|
|
|
Guidance for industry [electronic resource] : source animal, product, preclinical, and clinical issue
HE 20.4802:AN 5/3
;
Axe Federal Documents Online:Available
|
|
2003
|
|
Guidance for industry [electronic resource] : source animal, product, preclinical, and clinical issue
Axe Federal Documents Online:Available
|
|
2003
|
|
|
He 20. 4802 :An 8
|
|
|
|
S9 nonclinical evaluation for anticancer pharmaceuticals [electronic resource].
HE 20.4802:AN 8
;
Axe Federal Documents Online:Available
|
|
2009
|
|
S9 nonclinical evaluation for anticancer pharmaceuticals [electronic resource].
Axe Federal Documents Online:Available
|
|
2009
|
|
|
He 20. 4802 :Au 8
|
|
|
|
Guidance for industry and FDA staff [electronic resource] : class II special controls guidance docume
HE 20.4802:AU 8
;
Axe Federal Documents Online:Available
|
|
2007
|
|
Guidance for industry and FDA staff [electronic resource] : class II special controls guidance docume
Axe Federal Documents Online:Available
|
|
2007
|
|
|
He 20. 4802 :B 52
|
|
|
|
Guidance for industry [electronic resource] : manufacturing biological intermediates and biological d
HE 20.4802:B 52
;
Axe Federal Documents Online:Available
|
|
2007
|
|
Guidance for industry [electronic resource] : manufacturing biological intermediates and biological d
Axe Federal Documents Online:Available
|
|
2007
|
|
|
He 20. 4802 :B 52/ 2
|
|
|
|
Guidance for industry [electronic resource] : biological product deviation reporting for licensed man
HE 20.4802:B 52/2
;
Axe Federal Documents Online:Available
|
|
2008
|
|
Guidance for industry [electronic resource] : biological product deviation reporting for licensed man
Axe Federal Documents Online:Available
|
|
2008
|
|
|
He 20. 4802 :B 52/ 3
|
|
|
|
Guidance for industry [electronic resource] : biological product deviation reporting for blood and pl
HE 20.4802:B 52/3
;
Axe Federal Documents Online:Available
|
|
2006
|
|
Guidance for industry [electronic resource] : biological product deviation reporting for blood and pl
Axe Federal Documents Online:Available
|
|
2006
|
|
|
He 20. 4802 :B 52/ 4
|
|
|
|
Guidance for industry [electronic resource] : changes to an approved application : biological product
HE 20.4802:B 52/4
;
Axe Federal Documents Online:Available
|
|
2001
|
|
Guidance for industry [electronic resource] : changes to an approved application : biological product
Axe Federal Documents Online:Available
|
|
2001
|
|
|
He 20. 4802 :B 62
|
|
|
|
Guidance for industry [electronic resource] : blood establishment computer system validation in the u
HE 20.4802:B 62
;
Axe Federal Documents Online:Available
|
|
2007
|
|
Guidance for industry [electronic resource] : blood establishment computer system validation in the u
Axe Federal Documents Online:Available
|
|
2007
|
|
|
He 20. 4802 :B 62/ 2
|
|
|
|
Guidance for industries [electronic resource] : variances for blood collection from individuals with
HE 20.4802:B 62/2
;
Axe Federal Documents Online:Available
|
|
2001
|
|
Guidance for industries [electronic resource] : variances for blood collection from individuals with
Axe Federal Documents Online:Available
|
|
2001
|
|
|
He 20. 4802 :C 17
|
|
|
|
Guidance for industry [electronic resource] : S1C(R2) dose selection for carcinogenicity studies.
HE 20.4802:C 17
;
Axe Federal Documents Online:Available
|
|
2008
|
|
Guidance for industry [electronic resource] : S1C(R2) dose selection for carcinogenicity studies.
Axe Federal Documents Online:Available
|
|
2008
|
|
|
He 20. 4802 :C 33
|
|
|
|
Guidance for industry [electronic resource] : potency tests for cellular and gene therapy products.
HE 20.4802:C 33
;
Axe Federal Documents Online:Available
|
|
2008
|
|
Guidance for industry [electronic resource] : potency tests for cellular and gene therapy products.
Axe Federal Documents Online:Available
|
|
2008
|
|
|
He 20. 4802 :C 33/ 2
|
|
|
|
Guidance for industry [electronic resource] : certain human cells, tissues and cellular and tissue-ba
HE 20.4802:C 33/2
;
Axe Federal Documents Online:Available
|
|
2008
|
|
Guidance for industry [electronic resource] : certain human cells, tissues and cellular and tissue-ba
Axe Federal Documents Online:Available
|
|
2008
|
|
|
He 20. 4802 :C 33/ 3
|
|
|
|
Guidance for industry [electronic resource] : regulation of human cells, tissues, and cellular and ti
HE 20.4802:C 33/3
;
Axe Federal Documents Online:Available
|
|
2007
|
|
Guidance for industry [electronic resource] : regulation of human cells, tissues, and cellular and ti
Axe Federal Documents Online:Available
|
|
2007
|
|
|
He 20. 4802 :C 33/ 4
|
|
|
|
Guidance for industry [electronic resource] : cell selection devices for point of care production of
HE 20.4802:C 33/4
;
Axe Federal Documents Online:Available
|
|
2007
|
|
Guidance for industry [electronic resource] : cell selection devices for point of care production of
Axe Federal Documents Online:Available
|
|
2007
|
|
|
He 20. 4802 :C 33/ 5
|
|
|
|
Guidance for industry [electronic resource] : characterization and qualification of cell substrates a
HE 20.4802:C 33/5
;
Axe Federal Documents Online:Available
|
|
2006
|
|
Guidance for industry [electronic resource] : characterization and qualification of cell substrates a
Axe Federal Documents Online:Available
|
|
2006
|
|
|
He 20. 4802 :C 42
|
|
|
|
Guidance for FDA reviews and sponsors [electronic resource] : content and review of chemistry, manufa
HE 20.4802:C 42
;
Axe Federal Documents Online:Available
|
|
2008
|
|
Guidance for FDA reviews and sponsors [electronic resource] : content and review of chemistry, manufa
Axe Federal Documents Online:Available
|
|
2008
|
|
|
He 20. 4802 :C 42/ 2
|
|
|
|
Guidance for FDA reviews and sponsors : [electronic resource] : content and review of chemistry, manu
HE 20.4802:C 42/2
;
Axe Federal Documents Online:Available
|
|
2008
|
|
Guidance for FDA reviews and sponsors : [electronic resource] : content and review of chemistry, manu
Axe Federal Documents Online:Available
|
|
2008
|
|
|
He 20. 4802 :C 42/ 3
|
|
|
|
Guidance for industry for the submission of chemistry, manufacturing and controls and establishment d
HE 20.4802:C 42/3
;
Axe Federal Documents Online:Available
|
|
1999
|
|
Guidance for industry for the submission of chemistry, manufacturing and controls and establishment d
Axe Federal Documents Online:Available
|
|
1999
|
|
|
He 20. 4802 :C 49
|
|
|
|
Guidance for industry [electronic resource] : an acceptable circular of information for the use of hu
HE 20.4802:C 49
;
Axe Federal Documents Online:Available
|
|
2003
|
|
Guidance for industry [electronic resource] : an acceptable circular of information for the use of hu
Axe Federal Documents Online:Available
|
|
2003
|
|
|
He 20. 4802 :C 61
|
|
|
|
Guidance for clinical trial sponsors [electronic resource] : establishment and operation of clinical
HE 20.4802:C 61
;
Axe Federal Documents Online:Available
|
|
2006
|
|
Guidance for clinical trial sponsors [electronic resource] : establishment and operation of clinical
Axe Federal Documents Online:Available
|
|
2006
|
|
|
He 20. 4802 :C 61/ 2
|
|
|
|
Guidance for industry and clinical investigators [electronic resource] : the use of clinical holds fo
HE 20.4802:C 61/2
;
Axe Federal Documents Online:Available
|
|
2004
|
|
Guidance for industry and clinical investigators [electronic resource] : the use of clinical holds fo
Axe Federal Documents Online:Available
|
|
2004
|
|
|
He 20. 4802 :C 61/ 3
|
|
|
|
Guidance for clinical trial sponsors [electronic resource] : on the establishment and operation of cl
HE 20.4802:C 61/3
;
Axe Federal Documents Online:Available
|
|
2001
|
|
Guidance for clinical trial sponsors [electronic resource] : on the establishment and operation of cl
Axe Federal Documents Online:Available
|
|
2001
|
|
|
He 20. 4802 :C 67
|
|
|
|
Guidance for industry [electronic resource] : recommendations for collecting red blood cells by autom
HE 20.4802:C 67
;
Axe Federal Documents Online:Available
|
|
2001
|
|
Guidance for industry [electronic resource] : recommendations for collecting red blood cells by autom
Axe Federal Documents Online:Available
|
|
2001
|
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