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He 20. 4702 :Ad 9/
|
|
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Annual adverse drug experience report [electronic resource].
HE 20.4702:AD 9/
;
Axe Federal Documents Online:Available
|
ElectronicResource GovDoc
|
19--
|
|
Annual adverse drug experience report [electronic resource].
Axe Federal Documents Online:Available
|
ElectronicResource GovDoc
|
19--
|
|
|
He 20. 4702 :Ad 9/ 2
|
|
|
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Guidance for industry [electronic resource] : adverse reactions section of labeling for human prescri
HE 20.4702:AD 9/2
;
Axe Federal Documents Online:Available
|
ElectronicResource GovDoc
|
2006
|
|
Guidance for industry [electronic resource] : adverse reactions section of labeling for human prescri
Axe Federal Documents Online:Available
|
ElectronicResource GovDoc
|
2006
|
|
|
He 20. 4702 :Ad 9/ 3
|
|
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Guidance for industry [electronic resource] : advisory committees : implementing Section 120 of the F
HE 20.4702:AD 9/3
;
Axe Federal Documents Online:Available
|
ElectronicResource GovDoc
|
1998
|
|
Guidance for industry [electronic resource] : advisory committees : implementing Section 120 of the F
Axe Federal Documents Online:Available
|
ElectronicResource GovDoc
|
1998
|
|
|
He 20. 4702 :Am 3
|
|
|
|
Guidance for industry [electronic resource] : major, minor, and telephone amendments to abbreviated n
HE 20.4702:AM 3
;
Axe Federal Documents Online:Available
|
ElectronicResource GovDoc
|
2001
|
|
Guidance for industry [electronic resource] : major, minor, and telephone amendments to abbreviated n
Axe Federal Documents Online:Available
|
ElectronicResource GovDoc
|
2001
|
|
|
He 20. 4702 :An 8/ 4
|
|
|
|
Guidance for industry [electronic resource] : antiviral product development, conducting and submittin
HE 20.4702:AN 8/4
;
Axe Federal Documents Online:Available
|
ElectronicResource GovDoc
|
2006
|
|
Guidance for industry [electronic resource] : antiviral product development, conducting and submittin
Axe Federal Documents Online:Available
|
ElectronicResource GovDoc
|
2006
|
|
|
He 20. 4702 :B 23
|
|
|
|
Guidance for industry [electronic resource] : bar code label requirements, questions and answers.
HE 20.4702:B 23
;
Axe Federal Documents Online:Available
|
ElectronicResource GovDoc
|
2006
|
|
Guidance for industry [electronic resource] : bar code label requirements, questions and answers.
Axe Federal Documents Online:Available
|
ElectronicResource GovDoc
|
2006
|
|
|
He 20. 4702 :B 52
|
|
|
|
Quality of biotechnological products [electronic resource] : analysis of the expression construct in
HE 20.4702:B 52
;
Axe Federal Documents Online:Available
|
ElectronicResource GovDoc
|
1996
|
|
Quality of biotechnological products [electronic resource] : analysis of the expression construct in
Axe Federal Documents Online:Available
|
ElectronicResource GovDoc
|
1996
|
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He 20. 4702 :B 52/ 2
|
|
|
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Guidance for industry [electronic resource] : Q5E comparability of biotechnological/biological produc
HE 20.4702:B 52/2
;
Axe Federal Documents Online:Available
|
ElectronicResource GovDoc
|
2005
|
|
Guidance for industry [electronic resource] : Q5E comparability of biotechnological/biological produc
Axe Federal Documents Online:Available
|
ElectronicResource GovDoc
|
2005
|
|
|
He 20. 4702 :B 52/ 4
|
|
|
|
Guidance for industry [electronic resource] : bioanalytical method validation.
HE 20.4702:B 52/4
;
Axe Federal Documents Online:Available
|
ElectronicResource GovDoc
|
2001
|
|
Guidance for industry [electronic resource] : bioanalytical method validation.
Axe Federal Documents Online:Available
|
ElectronicResource GovDoc
|
2001
|
|
|
He 20. 4702 :B 52/ 5
|
|
|
|
Guidance for industry [electronic resource] : bioavailability and bioequivalence studies for nasal ae
HE 20.4702:B 52/5
;
Axe Federal Documents Online:Available
|
ElectronicResource GovDoc
|
2003
|
|
Guidance for industry [electronic resource] : bioavailability and bioequivalence studies for nasal ae
Axe Federal Documents Online:Available
|
ElectronicResource GovDoc
|
2003
|
|
|
He 20. 4702 :B 52/ 6
|
|
|
|
Guidance for industry [electronic resource] : statistical approaches to establishing bioequivalence.
HE 20.4702:B 52/6
;
Axe Federal Documents Online:Available
|
ElectronicResource GovDoc
|
2001
|
|
Guidance for industry [electronic resource] : statistical approaches to establishing bioequivalence.
Axe Federal Documents Online:Available
|
ElectronicResource GovDoc
|
2001
|
|
|
He 20. 4702 :B 52/ 7
|
|
|
|
Guidance for industry [electronic resource] : waiver of in vivo bioavailability studies for immediate
HE 20.4702:B 52/7
;
Axe Federal Documents Online:Available
|
ElectronicResource GovDoc
|
2000
|
|
Guidance for industry [electronic resource] : waiver of in vivo bioavailability studies for immediate
Axe Federal Documents Online:Available
|
ElectronicResource GovDoc
|
2000
|
|
|
He 20. 4702 :B 65
|
|
|
|
Guidance for industry [electronic resource] : botanical drug products.
HE 20.4702:B 65
;
Axe Federal Documents Online:Available
|
ElectronicResource GovDoc
|
2004
|
|
Guidance for industry [electronic resource] : botanical drug products.
Axe Federal Documents Online:Available
|
ElectronicResource GovDoc
|
2004
|
|
|
He 20. 4702 :B 72
|
|
|
|
Guidance for industry [electronic resource] : Q1D bracketing and matrixing designs for stability test
HE 20.4702:B 72
;
Axe Federal Documents Online:Available
|
ElectronicResource GovDoc
|
2003
|
|
Guidance for industry [electronic resource] : Q1D bracketing and matrixing designs for stability test
Axe Federal Documents Online:Available
|
ElectronicResource GovDoc
|
2003
|
|
|
He 20. 4702 :B 78
|
|
|
|
Guidance for industry [electronic resource] : consumer-directed broadcast advertisements.
HE 20.4702:B 78
;
Axe Federal Documents Online:Available
|
ElectronicResource GovDoc
|
1999
|
|
Guidance for industry [electronic resource] : consumer-directed broadcast advertisements.
Axe Federal Documents Online:Available
|
ElectronicResource GovDoc
|
1999
|
|
|
He 20. 4702 :B 78/ 2
|
|
|
|
Guidance for industry [electronic resource] : consumer-directed broadcast advertisements, questions a
HE 20.4702:B 78/2
;
Axe Federal Documents Online:Available
|
ElectronicResource GovDoc
|
1999
|
|
Guidance for industry [electronic resource] : consumer-directed broadcast advertisements, questions a
Axe Federal Documents Online:Available
|
ElectronicResource GovDoc
|
1999
|
|
|
He 20. 4702 :C 17
|
|
|
|
Guidance for industry [electronic resource] : S1B testing for carcinogenicity of pharmaceuticals.
HE 20.4702:C 17
;
Axe Federal Documents Online:Available
|
ElectronicResource GovDoc
|
1997
|
|
Guidance for industry [electronic resource] : S1B testing for carcinogenicity of pharmaceuticals.
Axe Federal Documents Online:Available
|
ElectronicResource GovDoc
|
1997
|
|
|
He 20. 4702 :C 17/ 2
|
|
|
|
Guidance for industry [electronic resource] : carcinogenicity study protocol submissions.
HE 20.4702:C 17/2
;
Axe Federal Documents Online:Available
|
ElectronicResource GovDoc
|
2002
|
|
Guidance for industry [electronic resource] : carcinogenicity study protocol submissions.
Axe Federal Documents Online:Available
|
ElectronicResource GovDoc
|
2002
|
|
|
He 20. 4702 :C 33/ 2
|
|
|
|
Guidance for sponsors, industry, researchers, investigators, and Food and Drug Administration staff [
HE 20.4702:C 33/2
;
Axe Federal Documents Online:Available
|
ElectronicResource GovDoc
|
2009
|
|
Guidance for sponsors, industry, researchers, investigators, and Food and Drug Administration staff [
Axe Federal Documents Online:Available
|
ElectronicResource GovDoc
|
2009
|
|
|
He 20. 4702 :C 42
|
|
|
|
Guidance for industry [electronic resource] : format and content for the CMC section of an annual rep
HE 20.4702:C 42
;
Axe Federal Documents Online:Available
|
ElectronicResource GovDoc
|
1994
|
|
Guidance for industry [electronic resource] : format and content for the CMC section of an annual rep
Axe Federal Documents Online:Available
|
ElectronicResource GovDoc
|
1994
|
|
|
He 20. 4702 :C 46
|
|
|
|
Reviewer guidance [electronic resource] : validation of chromatographic methods.
HE 20.4702:C 46
;
Axe Federal Documents Online:Available
|
ElectronicResource GovDoc
|
1994
|
|
Reviewer guidance [electronic resource] : validation of chromatographic methods.
Axe Federal Documents Online:Available
|
ElectronicResource GovDoc
|
1994
|
|
|
He 20. 4702 :C 61
|
|
|
|
Guidance for industry [electronic resource] : E14 clinical evaluation of QT/QTc interval prolongation
HE 20.4702:C 61
;
Axe Federal Documents Online:Available
|
ElectronicResource GovDoc
|
2005
|
|
Guidance for industry [electronic resource] : E14 clinical evaluation of QT/QTc interval prolongation
Axe Federal Documents Online:Available
|
ElectronicResource GovDoc
|
2005
|
|
|
He 20. 4702 :C 61/ 2
|
|
|
|
Guidance for industry [electronic resource] : E 11 clinical investigation of medicinal products in th
HE 20.4702:C 61/2
;
Axe Federal Documents Online:Available
|
ElectronicResource GovDoc
|
2000
|
|
Guidance for industry [electronic resource] : E 11 clinical investigation of medicinal products in th
Axe Federal Documents Online:Available
|
ElectronicResource GovDoc
|
2000
|
|
|
He 20. 4702 :C 61/ 3
|
|
|
|
Guidance for industry [electronic resource] : E6 good clinical practice, consolidated guidance.
HE 20.4702:C 61/3
;
Axe Federal Documents Online:Available
|
ElectronicResource GovDoc
|
2000
|
|
Guidance for industry [electronic resource] : E6 good clinical practice, consolidated guidance.
Axe Federal Documents Online:Available
|
ElectronicResource GovDoc
|
2000
|
|
|
He 20. 4702 :C 61/ 4
|
|
|
|
Guidance for industry [electronic resource] : acceptance of foreign clinical studies
HE 20.4702:C 61/4
;
Axe Federal Documents Online:Available
|
ElectronicResource GovDoc
|
2001
|
|
Guidance for industry [electronic resource] : acceptance of foreign clinical studies
Axe Federal Documents Online:Available
|
ElectronicResource GovDoc
|
2001
|
|
|
He 20. 4702 :C 61/ 5
|
|
|
|
Reviewer guidance [electronic resource] : conducting a clinical safety review of a new product applic
HE 20.4702:C 61/5
;
Axe Federal Documents Online:Available
|
ElectronicResource GovDoc
|
2005
|
|
Reviewer guidance [electronic resource] : conducting a clinical safety review of a new product applic
Axe Federal Documents Online:Available
|
ElectronicResource GovDoc
|
2005
|
|
|
He 20. 4702 :C 61/ 6
|
|
|
|
Guidance for industry [electronic resource] : E14 clinical evaluation of QT/QTc interval prolongation
HE 20.4702:C 61/6
;
Axe Federal Documents Online:Available
|
ElectronicResource GovDoc
|
2008
|
|
Guidance for industry [electronic resource] : E14 clinical evaluation of QT/QTc interval prolongation
Axe Federal Documents Online:Available
|
ElectronicResource GovDoc
|
2008
|
|
|
He 20. 4702 :C 62
|
|
|
|
Guidance for industry [electronic resource] : clozapine tables, in vivo bioequivalence and in vitro d
HE 20.4702:C 62
;
Axe Federal Documents Online:Available
|
ElectronicResource GovDoc
|
2005
|
|
Guidance for industry [electronic resource] : clozapine tables, in vivo bioequivalence and in vitro d
Axe Federal Documents Online:Available
|
ElectronicResource GovDoc
|
2005
|
|
|
He 20. 4702 :C 62/ 2
|
|
|
|
Guidance for industry [electronic resource] : container closure systems for packaging human drugs and
HE 20.4702:C 62/2
;
Axe Federal Documents Online:Available
|
ElectronicResource GovDoc
|
1999
|
|
Guidance for industry [electronic resource] : container closure systems for packaging human drugs and
Axe Federal Documents Online:Available
|
ElectronicResource GovDoc
|
1999
|
|
|
He 20. 4702 :C 62/ 3
|
|
|
|
Guidance for industry [electronic resource] : container closure systems for packaging human drugs and
HE 20.4702:C 62/3
;
Axe Federal Documents Online:Available
|
ElectronicResource GovDoc
|
2002
|
|
Guidance for industry [electronic resource] : container closure systems for packaging human drugs and
Axe Federal Documents Online:Available
|
ElectronicResource GovDoc
|
2002
|
|
|
He 20. 4702 :C 73
|
|
|
|
Guidance for industry [electronic resource] : M4, the CTD, efficacy questions and answers.
HE 20.4702:C 73
;
Axe Federal Documents Online:Available
|
ElectronicResource GovDoc
|
2004
|
|
Guidance for industry [electronic resource] : M4, the CTD, efficacy questions and answers.
Axe Federal Documents Online:Available
|
ElectronicResource GovDoc
|
2004
|
|
|
He 20. 4702 :C 73/ 2
|
|
|
|
Guidance for industry [electronic resource] : M4, the CTD, general questions and answers.
HE 20.4702:C 73/2
;
Axe Federal Documents Online:Available
|
ElectronicResource GovDoc
|
2004
|
|
Guidance for industry [electronic resource] : M4, the CTD, general questions and answers.
Axe Federal Documents Online:Available
|
ElectronicResource GovDoc
|
2004
|
|
|
He 20. 4702 :C 73/ 3
|
|
|
|
Guidance for industry [electronic resource] : M4E, the CTD, efficacy.
HE 20.4702:C 73/3
;
Axe Federal Documents Online:Available
|
ElectronicResource GovDoc
|
2001
|
|
Guidance for industry [electronic resource] : M4E, the CTD, efficacy.
Axe Federal Documents Online:Available
|
ElectronicResource GovDoc
|
2001
|
|
|
He 20. 4702 :C 73/ 4
|
|
|
|
Guidance for industry [electronic resource] : M4Q, the CTD, quality.
HE 20.4702:C 73/4
;
Axe Federal Documents Online:Available
|
ElectronicResource GovDoc
|
2001
|
|
Guidance for industry [electronic resource] : M4Q, the CTD, quality.
Axe Federal Documents Online:Available
|
ElectronicResource GovDoc
|
2001
|
|
|
He 20. 4702 :C 73/ 5
|
|
|
|
Guidance for industry [electronic resource] : M4S, the CTD, safety.
HE 20.4702:C 73/5
;
Axe Federal Documents Online:Available
|
ElectronicResource GovDoc
|
2001
|
|
Guidance for industry [electronic resource] : M4S, the CTD, safety.
Axe Federal Documents Online:Available
|
ElectronicResource GovDoc
|
2001
|
|
|
He 20. 4702 :C 74
|
|
|
|
Guidance for industry [electronic resource] : E 10 choice of control group and related issues in clin
HE 20.4702:C 74
;
Axe Federal Documents Online:Available
|
ElectronicResource GovDoc
|
2001
|
|
Guidance for industry [electronic resource] : E 10 choice of control group and related issues in clin
Axe Federal Documents Online:Available
|
ElectronicResource GovDoc
|
2001
|
|
|
He 20. 4702 :C 76
|
|
|
|
Guidance for industry [electronic resource] : E 10 choice of control group and related issues in clin
HE 20.4702:C 76
;
Axe Federal Documents Online:Available
|
ElectronicResource GovDoc
|
2001
|
|
Guidance for industry [electronic resource] : E 10 choice of control group and related issues in clin
Axe Federal Documents Online:Available
|
ElectronicResource GovDoc
|
2001
|
|
|
He 20. 4702 :C 81
|
|
|
|
Guidance [electronic resource] : topical dermatologic corticosteroids, in vivo bioequivalence
HE 20.4702:C 81
;
Axe Federal Documents Online:Available
|
ElectronicResource GovDoc
|
1995
|
|
Guidance [electronic resource] : topical dermatologic corticosteroids, in vivo bioequivalence
Axe Federal Documents Online:Available
|
ElectronicResource GovDoc
|
1995
|
|
|
He 20. 4702 :D 26
|
|
|
|
Revision of the ICH guideline on clinical safety data management [electronic resource] : data elemen
HE 20.4702:D 26
;
Axe Federal Documents Online:Available
|
ElectronicResource GovDoc
|
2005
|
|
Revision of the ICH guideline on clinical safety data management [electronic resource] : data elemen
Axe Federal Documents Online:Available
|
ElectronicResource GovDoc
|
2005
|
|
|
He 20. 4702 :D 26/ 2
|
|
|
|
Guidance for industry [electronic resource] : E2B(M), data elements for transmission of individual ca
HE 20.4702:D 26/2
;
Axe Federal Documents Online:Available
|
ElectronicResource GovDoc
|
2005
|
|
Guidance for industry [electronic resource] : E2B(M), data elements for transmission of individual ca
Axe Federal Documents Online:Available
|
ElectronicResource GovDoc
|
2005
|
|
|
He 20. 4702 :D 26/ 3
|
|
|
|
Guidance for industry [electronic resource] : E2BM data elements for transmission of individual case
HE 20.4702:D 26/3
;
Axe Federal Documents Online:Available
|
ElectronicResource GovDoc
|
2002
|
|
Guidance for industry [electronic resource] : E2BM data elements for transmission of individual case
Axe Federal Documents Online:Available
|
ElectronicResource GovDoc
|
2002
|
|
|
He 20. 4702 :D 26/ 4
|
|
|
|
Guidance for industry [electronic resource] : addendum to E2C clinical safety data management : peri
HE 20.4702:D 26/4
;
Axe Federal Documents Online:Available
|
ElectronicResource GovDoc
|
2004
|
|
Guidance for industry [electronic resource] : addendum to E2C clinical safety data management : peri
Axe Federal Documents Online:Available
|
ElectronicResource GovDoc
|
2004
|
|
|
He 20. 4702 :D 54
|
|
|
|
Diabetes [electronic resource].
HE 20.4702:D 54
;
Axe Federal Documents Online:Available
|
ElectronicResource GovDoc
|
2006
|
|
Diabetes [electronic resource].
Axe Federal Documents Online:Available
|
ElectronicResource GovDoc
|
2006
|
|
|
He 20. 4702 :D 63
|
|
|
|
Guidance for industry [electronic resource] : formal dispute resolution : scientific and technical is
HE 20.4702:D 63
;
Axe Federal Documents Online:Available
|
ElectronicResource GovDoc
|
2006
|
|
Guidance for industry [electronic resource] : formal dispute resolution : scientific and technical is
Axe Federal Documents Online:Available
|
ElectronicResource GovDoc
|
2006
|
|
|
He 20. 4702 :D 63/ 2
|
|
|
|
Guidance for industry [electronic resource] : formal dispute resolution, appeals above the division l
HE 20.4702:D 63/2
;
Axe Federal Documents Online:Available
|
ElectronicResource GovDoc
|
2000
|
|
Guidance for industry [electronic resource] : formal dispute resolution, appeals above the division l
Axe Federal Documents Online:Available
|
ElectronicResource GovDoc
|
2000
|
|
|
He 20. 4702 :D 63/ 3
|
|
|
|
Guidance for industry [electronic resource] : dissolution testing of immediate release solid oral dos
HE 20.4702:D 63/3
;
Axe Federal Documents Online:Available
|
ElectronicResource GovDoc
|
1997
|
|
Guidance for industry [electronic resource] : dissolution testing of immediate release solid oral dos
Axe Federal Documents Online:Available
|
ElectronicResource GovDoc
|
1997
|
|
|
He 20. 4702 :D 65
|
|
|
|
Guideline for submitting documentation for the manufacture of and controls for drug products [electro
HE 20.4702:D 65
;
Axe Federal Documents Online:Available
|
ElectronicResource GovDoc
|
1987
|
|
Guideline for submitting documentation for the manufacture of and controls for drug products [electro
Axe Federal Documents Online:Available
|
ElectronicResource GovDoc
|
1987
|
|
|
He 20. 4702 :D 65/ 2
|
|
|
|
Guideline for submitting supporting documentation in drug applications for the manufacture of drug su
HE 20.4702:D 65/2
;
Axe Federal Documents Online:Available
|
ElectronicResource GovDoc
|
1987
|
|
Guideline for submitting supporting documentation in drug applications for the manufacture of drug su
Axe Federal Documents Online:Available
|
ElectronicResource GovDoc
|
1987
|
|
|
He 20. 4702 :D 74
|
|
|
|
Guidance for industry [electronic resource] : expiration dating and stability testing of solid oral d
HE 20.4702:D 74
;
Axe Federal Documents Online:Available
|
ElectronicResource GovDoc
|
1997
|
|
Guidance for industry [electronic resource] : expiration dating and stability testing of solid oral d
Axe Federal Documents Online:Available
|
ElectronicResource GovDoc
|
1997
|
|
|
He 20. 4702 :D 74/ 2/ 2011
|
|
|
|
Guidance for industry - dosage delivery devices for OTC liquid drug products [electronic resource].
HE 20.4702:D 74/2/2011
;
Axe Federal Documents Online:Available
|
ElectronicResource GovDoc
|
2011
|
|
Guidance for industry - dosage delivery devices for OTC liquid drug products [electronic resource].
Axe Federal Documents Online:Available
|
ElectronicResource GovDoc
|
2011
|
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