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He 20. 4702 :L 11
|
|
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Guidance for industry [electronic resource] : clinical lactation studies; study design, data analysis
HE 20.4702:L 11
;
Axe Federal Documents Online:Available
|
|
2005
|
|
Guidance for industry [electronic resource] : clinical lactation studies; study design, data analysis
Axe Federal Documents Online:Available
|
|
2005
|
|
|
He 20. 4702 :L 11/ 3
|
|
|
|
Guidance for industry [electronic resource] : clinical studies section of labeling for human prescrip
HE 20.4702:L 11/3
;
Axe Federal Documents Online:Available
|
|
2006
|
|
Guidance for industry [electronic resource] : clinical studies section of labeling for human prescrip
Axe Federal Documents Online:Available
|
|
2006
|
|
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He 20. 4702 :L 11/ 4
|
|
|
|
Guidance for industry [electronic resource] : revising and ANDA labeling following revision of the RL
HE 20.4702:L 11/4
;
Axe Federal Documents Online:Available
|
|
2000
|
|
Guidance for industry [electronic resource] : revising and ANDA labeling following revision of the RL
Axe Federal Documents Online:Available
|
|
2000
|
|
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He 20. 4702 :L 11/ 5
|
|
|
|
Guidance for industry [electronic resource] : content and format for geriatric labeling.
HE 20.4702:L 11/5
;
Axe Federal Documents Online:Available
|
|
2001
|
|
Guidance for industry [electronic resource] : content and format for geriatric labeling.
Axe Federal Documents Online:Available
|
|
2001
|
|
|
He 20. 4702 :L 11/ 10
|
|
|
|
Guidance for industry [electronic resource] : implementation of Section 126 of the Food and Drug Admi
HE 20.4702:L 11/10
;
Axe Federal Documents Online:Available
|
|
1998
|
|
Guidance for industry [electronic resource] : implementation of Section 126 of the Food and Drug Admi
Axe Federal Documents Online:Available
|
|
1998
|
|
|
He 20. 4702 :L 75
|
|
|
|
Guidance for industry [electronic resource] : drug-induced liver injury, premarketing clinical evalua
HE 20.4702:L 75
;
Axe Federal Documents Online:Available
|
|
2009
|
|
Guidance for industry [electronic resource] : drug-induced liver injury, premarketing clinical evalua
Axe Federal Documents Online:Available
|
|
2009
|
|
|
He 20. 4702 :M 31
|
|
|
|
Guidance for industry [electronic resource] : Q7A good manufacturing practice guidance for active pha
HE 20.4702:M 31
;
Axe Federal Documents Online:Available
|
|
2001
|
|
Guidance for industry [electronic resource] : Q7A good manufacturing practice guidance for active pha
Axe Federal Documents Online:Available
|
|
2001
|
|
|
He 20. 4702 :M 34
|
|
|
|
Guidance for industry [electronic resource] : submitting marketing applications according to the ICH-
HE 20.4702:M 34
;
Axe Federal Documents Online:Available
|
|
2001
|
|
Guidance for industry [electronic resource] : submitting marketing applications according to the ICH-
Axe Federal Documents Online:Available
|
|
2001
|
|
|
He 20. 4702 :M 47/Rev. 1
|
|
|
|
Guidance for industry [electronic resource] : formal meetings between the FDA and sponsors or applica
HE 20.4702:M 47/REV.1
;
Axe Federal Documents Online:Available
|
|
2009
|
|
Guidance for industry [electronic resource] : formal meetings between the FDA and sponsors or applica
Axe Federal Documents Online:Available
|
|
2009
|
|
|
He 20. 4702 :M 58
|
|
|
|
Guideline for the format and content of the microbiology section of an application [electronic resour
HE 20.4702:M 58
;
Axe Federal Documents Online:Available
|
|
1990
|
|
Guideline for the format and content of the microbiology section of an application [electronic resour
Axe Federal Documents Online:Available
|
|
1990
|
|
|
He 20. 4702 :M 74/ 2
|
|
|
|
Guidance for industry [electronic resource] : monoclonal antibodies used as reagents in drug manufact
HE 20.4702:M 74/2
;
Axe Federal Documents Online:Available
|
|
2001
|
|
Guidance for industry [electronic resource] : monoclonal antibodies used as reagents in drug manufact
Axe Federal Documents Online:Available
|
|
2001
|
|
|
He 20. 4702 :N 17
|
|
|
|
Guidance for industry [electronic resource] : nasal spray and inhalation solution, suspension, and sp
HE 20.4702:N 17
;
Axe Federal Documents Online:Available
|
|
2002
|
|
Guidance for industry [electronic resource] : nasal spray and inhalation solution, suspension, and sp
Axe Federal Documents Online:Available
|
|
2002
|
|
|
He 20. 4702 :N 42
|
|
|
|
Guidance for industry [electronic resource] : changes to an approved NDA or ANDA.
HE 20.4702:N 42
;
Axe Federal Documents Online:Available
|
|
2004
|
|
Guidance for industry [electronic resource] : changes to an approved NDA or ANDA.
Axe Federal Documents Online:Available
|
|
2004
|
|
|
He 20. 4702 :N 42/ 2
|
|
|
|
Guidance for industry [electronic resource] : changes to an approved NDA or ANDA, questions and answe
HE 20.4702:N 42/2
;
Axe Federal Documents Online:Available
|
|
2001
|
|
Guidance for industry [electronic resource] : changes to an approved NDA or ANDA, questions and answe
Axe Federal Documents Online:Available
|
|
2001
|
|
|
He 20. 4702 :N 42/ 3
|
|
|
|
Guidance for industry [electronic resource] : changes to an approved NDA or ANDA, specifications, use
HE 20.4702:N 42/3
;
Axe Federal Documents Online:Available
|
|
2004
|
|
Guidance for industry [electronic resource] : changes to an approved NDA or ANDA, specifications, use
Axe Federal Documents Online:Available
|
|
2004
|
|
|
He 20. 4702 :N 73/ 2
|
|
|
|
Guidance for industry [electronic resource] : S7B nonclinical evaluation of the potential for delayed
HE 20.4702:N 73/2
;
Axe Federal Documents Online:Available
|
|
2005
|
|
Guidance for industry [electronic resource] : S7B nonclinical evaluation of the potential for delayed
Axe Federal Documents Online:Available
|
|
2005
|
|
|
He 20. 4702 :N 73/ 3
|
|
|
|
Guideline for the format and content of the nonclinical pharmacology/toxicology section of an applica
HE 20.4702:N 73/3
;
Axe Federal Documents Online:Available
|
|
1987
|
|
Guideline for the format and content of the nonclinical pharmacology/toxicology section of an applica
Axe Federal Documents Online:Available
|
|
1987
|
|
|
He 20. 4702 :Or 1
|
|
|
|
Guidance for industry [electronic resource] : extended release oral dosage forms, development, evalua
HE 20.4702:OR 1
;
Axe Federal Documents Online:Available
|
|
1997
|
|
Guidance for industry [electronic resource] : extended release oral dosage forms, development, evalua
Axe Federal Documents Online:Available
|
|
1997
|
|
|
He 20. 4702 :Or 3
|
|
|
|
Guidance for industry [electronic resource] : M4, organization of the CTD.
HE 20.4702:OR 3
;
Axe Federal Documents Online:Available
|
|
2001
|
|
Guidance for industry [electronic resource] : M4, organization of the CTD.
Axe Federal Documents Online:Available
|
|
2001
|
|
|
He 20. 4702 :Ot 4/Draft
|
|
|
|
Guidance for industry [electronic resource] : acute bacterial otitis media, developing drugs for trea
HE 20.4702:OT 4/DRAFT
;
Axe Federal Documents Online:Available
|
|
2008
|
|
Guidance for industry [electronic resource] : acute bacterial otitis media, developing drugs for trea
Axe Federal Documents Online:Available
|
|
2008
|
|
|
He 20. 4702 :Ou 8
|
|
|
|
Guidance for industry [electronic resource] : investigating out-of-specification test results (OOS) f
HE 20.4702:OU 8
;
Axe Federal Documents Online:Available
|
|
2006
|
|
Guidance for industry [electronic resource] : investigating out-of-specification test results (OOS) f
Axe Federal Documents Online:Available
|
|
2006
|
|
|
He 20. 4702 :P 21
|
|
|
|
Guidance for industry [electronic resource] : submission of documentation in applications for paramet
HE 20.4702:P 21
;
Axe Federal Documents Online:Available
|
|
2010
|
|
Guidance for industry [electronic resource] : submission of documentation in applications for paramet
Axe Federal Documents Online:Available
|
|
2010
|
|
|
He 20. 4702 :P 27
|
|
|
|
Guidance for industry [electronic resource] : patient-reported outcome measures, use in medical produ
HE 20.4702:P 27
;
Axe Federal Documents Online:Available
|
|
2006
|
|
Guidance for industry [electronic resource] : patient-reported outcome measures, use in medical produ
Axe Federal Documents Online:Available
|
|
2006
|
|
|
He 20. 4702 :P 34
|
|
|
|
Guidance for industry [electronic resource] : how to comply with the Pediatric Research Equity Act.
HE 20.4702:P 34
;
Axe Federal Documents Online:Available
|
|
2005
|
|
Guidance for industry [electronic resource] : how to comply with the Pediatric Research Equity Act.
Axe Federal Documents Online:Available
|
|
2005
|
|
|
He 20. 4702 :P 34/ 2
|
|
|
|
Guidance for industry [electronic resource] : qualifying for pediatric exclusivity under section 505A
HE 20.4702:P 34/2
;
Axe Federal Documents Online:Available
|
|
1999
|
|
Guidance for industry [electronic resource] : qualifying for pediatric exclusivity under section 505A
Axe Federal Documents Online:Available
|
|
1999
|
|
|
He 20. 4702 :P 34/ 3
|
|
|
|
Guidance for industry [electronic resource] : nonclinical safety evaluation of pediatric drug product
HE 20.4702:P 34/3
;
Axe Federal Documents Online:Available
|
|
2006
|
|
Guidance for industry [electronic resource] : nonclinical safety evaluation of pediatric drug product
Axe Federal Documents Online:Available
|
|
2006
|
|
|
He 20. 4702 :P 49
|
|
|
|
Guidance for industry [electronic resource] : Q4B evaluation and recommendation of pharmacopoeial tex
HE 20.4702:P 49
;
Axe Federal Documents Online:Available
|
|
2008
|
|
Guidance for industry [electronic resource] : Q4B evaluation and recommendation of pharmacopoeial tex
Axe Federal Documents Online:Available
|
|
2008
|
|
|
He 20. 4702 :P 49/ 2
|
|
|
|
Guidance for industry [electronic resource] : pharmacogenomic data submissions.
HE 20.4702:P 49/2
;
Axe Federal Documents Online:Available
|
|
2005
|
|
Guidance for industry [electronic resource] : pharmacogenomic data submissions.
Axe Federal Documents Online:Available
|
|
2005
|
|
|
He 20. 4702 :P 49/ 3/Rev. 2
|
|
|
|
Guidance for industry [electronic resource] : Q8(R2) pharmaceutical development.
HE 20.4702:P 49/3/REV.2
;
Axe Federal Documents Online:Available
|
|
2009
|
|
Guidance for industry [electronic resource] : Q8(R2) pharmaceutical development.
Axe Federal Documents Online:Available
|
|
2009
|
|
|
He 20. 4702 :P 49/ 4
|
|
|
|
Guidance for industry [electronic resource] : E2E pharmacovigilance planning.
HE 20.4702:P 49/4
;
Axe Federal Documents Online:Available
|
|
2005
|
|
Guidance for industry [electronic resource] : E2E pharmacovigilance planning.
Axe Federal Documents Online:Available
|
|
2005
|
|
|
He 20. 4702 :P 49/ 5
|
|
|
|
Guidance for industry [electronic resource] : good pharmacovigilance practices and pharmacoepidemiolo
HE 20.4702:P 49/5
;
Axe Federal Documents Online:Available
|
|
2005
|
|
Guidance for industry [electronic resource] : good pharmacovigilance practices and pharmacoepidemiolo
Axe Federal Documents Online:Available
|
|
2005
|
|
|
He 20. 4702 :P 49/ 6
|
|
|
|
Guidance for industry [electronic resource] : PAT, a framework for innovative pharmaceutical developm
HE 20.4702:P 49/6
;
Axe Federal Documents Online:Available
|
|
2004
|
|
Guidance for industry [electronic resource] : PAT, a framework for innovative pharmaceutical developm
Axe Federal Documents Online:Available
|
|
2004
|
|
|
He 20. 4702 :P 49/ 7
|
|
|
|
Guidance for industry [electronic resource] : manufacturing, processing, or holding active pharmaceut
HE 20.4702:P 49/7
;
Axe Federal Documents Online:Available
|
|
1998
|
|
Guidance for industry [electronic resource] : manufacturing, processing, or holding active pharmaceut
Axe Federal Documents Online:Available
|
|
1998
|
|
|
He 20. 4702 :P 49/ 8
|
|
|
|
Guidance for industry [electronic resource] : pharmaceutical components at risk for melamine contamin
HE 20.4702:P 49/8
;
Axe Federal Documents Online:Available
|
|
2009
|
|
Guidance for industry [electronic resource] : pharmaceutical components at risk for melamine contamin
Axe Federal Documents Online:Available
|
|
2009
|
|
|
He 20. 4702 :P 49/ 9
|
|
|
|
Guidance for industry [electronic resource] : population pharmacokinetics.
HE 20.4702:P 49/9
;
Axe Federal Documents Online:Available
|
|
1999
|
|
Guidance for industry [electronic resource] : population pharmacokinetics.
Axe Federal Documents Online:Available
|
|
1999
|
|
|
He 20. 4702 :P 49/ 10
|
|
|
|
Guidance for industry [electronic resource] : pharmacogenomic data submissions, companion evidence.
HE 20.4702:P 49/10
;
Axe Federal Documents Online:Available
|
|
2007
|
|
Guidance for industry [electronic resource] : pharmacogenomic data submissions, companion evidence.
Axe Federal Documents Online:Available
|
|
2007
|
|
|
He 20. 4702 :P 49/ 11
|
|
|
|
Guidance for industry [electronic resource] : photosafety testing.
HE 20.4702:P 49/11
;
Axe Federal Documents Online:Available
|
|
2003
|
|
Guidance for industry [electronic resource] : photosafety testing.
Axe Federal Documents Online:Available
|
|
2003
|
|
|
He 20. 4702 :P 49/Annex 1
|
|
|
|
Guidance for industry [electronic resource] : Q4B evaluation and recommendation of pharmacopoeial tex
HE 20.4702:P 49/ANNEX 1
;
Axe Federal Documents Online:Available
|
|
2008
|
|
Guidance for industry [electronic resource] : Q4B evaluation and recommendation of pharmacopoeial tex
Axe Federal Documents Online:Available
|
|
2008
|
|
|
He 20. 4702 :P 49/Annex 2
|
|
|
|
Guidance for industry [electronic resource] : Q4B evaluation and recommendation of pharmacopoeial tex
HE 20.4702:P 49/ANNEX 2
;
Axe Federal Documents Online:Available
|
|
2009
|
|
Guidance for industry [electronic resource] : Q4B evaluation and recommendation of pharmacopoeial tex
Axe Federal Documents Online:Available
|
|
2009
|
|
|
He 20. 4702 :P 49/Annex 3
|
|
|
|
Guidance for industry : Q4B evaluation and recommendation of pharmacopoeial texts for use in the ICH
HE 20.4702:P 49/ANNEX 3
;
Axe Federal Documents Online:Available
|
|
2009
|
|
Guidance for industry : Q4B evaluation and recommendation of pharmacopoeial texts for use in the ICH
Axe Federal Documents Online:Available
|
|
2009
|
|
|
He 20. 4702 :P 49/Annex 4a
|
|
|
|
Guidance for industry [electronic resource] : Q4B evaluation and recommendation of pharmacopoeial tex
HE 20.4702:P 49/ANNEX 4 A
;
Axe Federal Documents Online:Available
|
|
2009
|
|
Guidance for industry [electronic resource] : Q4B evaluation and recommendation of pharmacopoeial tex
Axe Federal Documents Online:Available
|
|
2009
|
|
|
He 20. 4702 :P 49/Annex 4b
|
|
|
|
Guidance for industry [electronic resource] : Q4B evaluation and recommendation of pharmacopoeial tex
HE 20.4702:P 49/ANNEX 4 B
;
Axe Federal Documents Online:Available
|
|
2009
|
|
Guidance for industry [electronic resource] : Q4B evaluation and recommendation of pharmacopoeial tex
Axe Federal Documents Online:Available
|
|
2009
|
|
|
He 20. 4702 :P 49/Annex 4c
|
|
|
|
Guidance for industry [electronic resource] : Q4B evaluation and recommendation of pharmacopoeial tex
HE 20.4702:P 49/ANNEX 4 C
;
Axe Federal Documents Online:Available
|
|
2009
|
|
Guidance for industry [electronic resource] : Q4B evaluation and recommendation of pharmacopoeial tex
Axe Federal Documents Online:Available
|
|
2009
|
|
|
He 20. 4702 :P 49/Annex 5/Draft
|
|
|
|
Q4B evaluation and recommendation of pharmacopeoial texts for use in the ICH regions. Annex 5, Disint
HE 20.4702:P 49/ANNEX 5/DRAFT
;
Axe Federal Documents Online:Available
|
|
2008
|
|
Q4B evaluation and recommendation of pharmacopeoial texts for use in the ICH regions. Annex 5, Disint
Axe Federal Documents Online:Available
|
|
2008
|
|
|
He 20. 4702 :P 49/Annex 6/Draft
|
|
|
|
Q4B evaluation and recommendation of pharmacopeoial texts for use in the ICH regions. Annex 6, Unifor
HE 20.4702:P 49/ANNEX 6/DRAFT
;
Axe Federal Documents Online:Available
|
|
2008
|
|
Q4B evaluation and recommendation of pharmacopeoial texts for use in the ICH regions. Annex 6, Unifor
Axe Federal Documents Online:Available
|
|
2008
|
|
|
He 20. 4702 :P 49/Annex 7/Draft
|
|
|
|
Q4B evaluation and recommendation of pharmacopeoial texts for use in the ICH regions. Annex 7, Dissol
HE 20.4702:P 49/ANNEX 7/DRAFT
;
Axe Federal Documents Online:Available
|
|
2008
|
|
Q4B evaluation and recommendation of pharmacopeoial texts for use in the ICH regions. Annex 7, Dissol
Axe Federal Documents Online:Available
|
|
2008
|
|
|
He 20. 4702 :P 49/Annex 8/Draft
|
|
|
|
Q4B evaluation and recommendation of pharmacopeoial texts for use in the ICH regions. Annex 8, Steril
HE 20.4702:P 49/ANNEX 8/DRAFT
;
Axe Federal Documents Online:Available
|
|
2008
|
|
Q4B evaluation and recommendation of pharmacopeoial texts for use in the ICH regions. Annex 8, Steril
Axe Federal Documents Online:Available
|
|
2008
|
|
|
He 20. 4702 :P 49/Annex 9
|
|
|
|
Q4B evaluation and recommendation of pharmacopoeial texts for use in the ICH regions [electronic reso
HE 20.4702:P 49/ANNEX 9
;
Axe Federal Documents Online:Available
|
|
2009
|
|
Q4B evaluation and recommendation of pharmacopoeial texts for use in the ICH regions [electronic reso
Axe Federal Documents Online:Available
|
|
2009
|
|
|
He 20. 4702 :P 56
|
|
|
|
Guidance for industry [electronic resource] : Q1B photostability testing of new drug substances and p
HE 20.4702:P 56
;
Axe Federal Documents Online:Available
|
|
1996
|
|
Guidance for industry [electronic resource] : Q1B photostability testing of new drug substances and p
Axe Federal Documents Online:Available
|
|
1996
|
|
|
He 20. 4702 :P 76
|
|
|
|
Guidance for industry [electronic resource] : ANDAs, pharmaceutical solid polymorphism, chemistry, ma
HE 20.4702:P 76
;
Axe Federal Documents Online:Available
|
|
2007
|
|
Guidance for industry [electronic resource] : ANDAs, pharmaceutical solid polymorphism, chemistry, ma
Axe Federal Documents Online:Available
|
|
2007
|
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