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He 20. 4702 :N 42
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Guidance for industry [electronic resource] : changes to an approved NDA or ANDA.
HE 20.4702:N 42
;
Axe Federal Documents Online:Available
|
ElectronicResource GovDoc
|
2004
|
|
Guidance for industry [electronic resource] : changes to an approved NDA or ANDA.
Axe Federal Documents Online:Available
|
ElectronicResource GovDoc
|
2004
|
|
|
He 20. 4702 :N 42/ 2
|
|
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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
|
ElectronicResource GovDoc
|
2001
|
|
Guidance for industry [electronic resource] : changes to an approved NDA or ANDA, questions and answe
Axe Federal Documents Online:Available
|
ElectronicResource GovDoc
|
2001
|
|
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He 20. 4702 :N 42/ 3
|
|
|
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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
|
ElectronicResource GovDoc
|
2004
|
|
Guidance for industry [electronic resource] : changes to an approved NDA or ANDA, specifications, use
Axe Federal Documents Online:Available
|
ElectronicResource GovDoc
|
2004
|
|
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He 20. 4702 :N 73/ 2
|
|
|
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Guidance for industry [electronic resource] : S7B nonclinical evaluation of the potential for delayed
HE 20.4702:N 73/2
;
Axe Federal Documents Online:Available
|
ElectronicResource GovDoc
|
2005
|
|
Guidance for industry [electronic resource] : S7B nonclinical evaluation of the potential for delayed
Axe Federal Documents Online:Available
|
ElectronicResource GovDoc
|
2005
|
|
|
He 20. 4702 :N 73/ 3
|
|
|
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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
|
ElectronicResource GovDoc
|
1987
|
|
Guideline for the format and content of the nonclinical pharmacology/toxicology section of an applica
Axe Federal Documents Online:Available
|
ElectronicResource GovDoc
|
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
|
ElectronicResource GovDoc
|
1997
|
|
Guidance for industry [electronic resource] : extended release oral dosage forms, development, evalua
Axe Federal Documents Online:Available
|
ElectronicResource GovDoc
|
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
|
ElectronicResource GovDoc
|
2001
|
|
Guidance for industry [electronic resource] : M4, organization of the CTD.
Axe Federal Documents Online:Available
|
ElectronicResource GovDoc
|
2001
|
|
|
He 20. 4702 :Ot 4/Draft
|
|
|
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Guidance for industry [electronic resource] : acute bacterial otitis media, developing drugs for trea
HE 20.4702:OT 4/DRAFT
;
Axe Federal Documents Online:Available
|
ElectronicResource GovDoc
|
2008
|
|
Guidance for industry [electronic resource] : acute bacterial otitis media, developing drugs for trea
Axe Federal Documents Online:Available
|
ElectronicResource GovDoc
|
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
|
ElectronicResource GovDoc
|
2006
|
|
Guidance for industry [electronic resource] : investigating out-of-specification test results (OOS) f
Axe Federal Documents Online:Available
|
ElectronicResource GovDoc
|
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
|
ElectronicResource GovDoc
|
2010
|
|
Guidance for industry [electronic resource] : submission of documentation in applications for paramet
Axe Federal Documents Online:Available
|
ElectronicResource GovDoc
|
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
|
ElectronicResource GovDoc
|
2006
|
|
Guidance for industry [electronic resource] : patient-reported outcome measures, use in medical produ
Axe Federal Documents Online:Available
|
ElectronicResource GovDoc
|
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
|
ElectronicResource GovDoc
|
2005
|
|
Guidance for industry [electronic resource] : how to comply with the Pediatric Research Equity Act.
Axe Federal Documents Online:Available
|
ElectronicResource GovDoc
|
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
|
ElectronicResource GovDoc
|
1999
|
|
Guidance for industry [electronic resource] : qualifying for pediatric exclusivity under section 505A
Axe Federal Documents Online:Available
|
ElectronicResource GovDoc
|
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
|
ElectronicResource GovDoc
|
2006
|
|
Guidance for industry [electronic resource] : nonclinical safety evaluation of pediatric drug product
Axe Federal Documents Online:Available
|
ElectronicResource GovDoc
|
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
|
ElectronicResource GovDoc
|
2008
|
|
Guidance for industry [electronic resource] : Q4B evaluation and recommendation of pharmacopoeial tex
Axe Federal Documents Online:Available
|
ElectronicResource GovDoc
|
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
|
ElectronicResource GovDoc
|
2005
|
|
Guidance for industry [electronic resource] : pharmacogenomic data submissions.
Axe Federal Documents Online:Available
|
ElectronicResource GovDoc
|
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
|
ElectronicResource GovDoc
|
2009
|
|
Guidance for industry [electronic resource] : Q8(R2) pharmaceutical development.
Axe Federal Documents Online:Available
|
ElectronicResource GovDoc
|
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
|
ElectronicResource GovDoc
|
2005
|
|
Guidance for industry [electronic resource] : E2E pharmacovigilance planning.
Axe Federal Documents Online:Available
|
ElectronicResource GovDoc
|
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
|
ElectronicResource GovDoc
|
2005
|
|
Guidance for industry [electronic resource] : good pharmacovigilance practices and pharmacoepidemiolo
Axe Federal Documents Online:Available
|
ElectronicResource GovDoc
|
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
|
ElectronicResource GovDoc
|
2004
|
|
Guidance for industry [electronic resource] : PAT, a framework for innovative pharmaceutical developm
Axe Federal Documents Online:Available
|
ElectronicResource GovDoc
|
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
|
ElectronicResource GovDoc
|
1998
|
|
Guidance for industry [electronic resource] : manufacturing, processing, or holding active pharmaceut
Axe Federal Documents Online:Available
|
ElectronicResource GovDoc
|
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
|
ElectronicResource GovDoc
|
2009
|
|
Guidance for industry [electronic resource] : pharmaceutical components at risk for melamine contamin
Axe Federal Documents Online:Available
|
ElectronicResource GovDoc
|
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
|
ElectronicResource GovDoc
|
1999
|
|
Guidance for industry [electronic resource] : population pharmacokinetics.
Axe Federal Documents Online:Available
|
ElectronicResource GovDoc
|
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
|
ElectronicResource GovDoc
|
2007
|
|
Guidance for industry [electronic resource] : pharmacogenomic data submissions, companion evidence.
Axe Federal Documents Online:Available
|
ElectronicResource GovDoc
|
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
|
ElectronicResource GovDoc
|
2003
|
|
Guidance for industry [electronic resource] : photosafety testing.
Axe Federal Documents Online:Available
|
ElectronicResource GovDoc
|
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
|
ElectronicResource GovDoc
|
2008
|
|
Guidance for industry [electronic resource] : Q4B evaluation and recommendation of pharmacopoeial tex
Axe Federal Documents Online:Available
|
ElectronicResource GovDoc
|
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
|
ElectronicResource GovDoc
|
2009
|
|
Guidance for industry [electronic resource] : Q4B evaluation and recommendation of pharmacopoeial tex
Axe Federal Documents Online:Available
|
ElectronicResource GovDoc
|
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
|
ElectronicResource GovDoc
|
2009
|
|
Guidance for industry [electronic resource] : Q4B evaluation and recommendation of pharmacopoeial tex
Axe Federal Documents Online:Available
|
ElectronicResource GovDoc
|
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
|
ElectronicResource GovDoc
|
2009
|
|
Guidance for industry [electronic resource] : Q4B evaluation and recommendation of pharmacopoeial tex
Axe Federal Documents Online:Available
|
ElectronicResource GovDoc
|
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
|
ElectronicResource GovDoc
|
2009
|
|
Guidance for industry [electronic resource] : Q4B evaluation and recommendation of pharmacopoeial tex
Axe Federal Documents Online:Available
|
ElectronicResource GovDoc
|
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
|
ElectronicResource GovDoc
|
2008
|
|
Q4B evaluation and recommendation of pharmacopeoial texts for use in the ICH regions. Annex 5, Disint
Axe Federal Documents Online:Available
|
ElectronicResource GovDoc
|
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
|
ElectronicResource GovDoc
|
2008
|
|
Q4B evaluation and recommendation of pharmacopeoial texts for use in the ICH regions. Annex 6, Unifor
Axe Federal Documents Online:Available
|
ElectronicResource GovDoc
|
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
|
ElectronicResource GovDoc
|
2008
|
|
Q4B evaluation and recommendation of pharmacopeoial texts for use in the ICH regions. Annex 7, Dissol
Axe Federal Documents Online:Available
|
ElectronicResource GovDoc
|
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
|
ElectronicResource GovDoc
|
2008
|
|
Q4B evaluation and recommendation of pharmacopeoial texts for use in the ICH regions. Annex 8, Steril
Axe Federal Documents Online:Available
|
ElectronicResource GovDoc
|
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
|
ElectronicResource GovDoc
|
2009
|
|
Q4B evaluation and recommendation of pharmacopoeial texts for use in the ICH regions [electronic reso
Axe Federal Documents Online:Available
|
ElectronicResource GovDoc
|
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
|
ElectronicResource GovDoc
|
1996
|
|
Guidance for industry [electronic resource] : Q1B photostability testing of new drug substances and p
Axe Federal Documents Online:Available
|
ElectronicResource GovDoc
|
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
|
ElectronicResource GovDoc
|
2007
|
|
Guidance for industry [electronic resource] : ANDAs, pharmaceutical solid polymorphism, chemistry, ma
Axe Federal Documents Online:Available
|
ElectronicResource GovDoc
|
2007
|
|
|
He 20. 4702 :P 84
|
|
|
|
Guidance for industry [electronic resource] : reports on the status of postmarketing study commitmen
HE 20.4702:P 84
;
Axe Federal Documents Online:Available
|
ElectronicResource GovDoc
|
2006
|
|
Guidance for industry [electronic resource] : reports on the status of postmarketing study commitmen
Axe Federal Documents Online:Available
|
ElectronicResource GovDoc
|
2006
|
|
|
He 20. 4702 :P 84/ 4
|
|
|
|
Guidance for industry [electronic resource] : potassium chloride modified-release tablets and capsule
HE 20.4702:P 84/4
;
Axe Federal Documents Online:Available
|
ElectronicResource GovDoc
|
2005
|
|
Guidance for industry [electronic resource] : potassium chloride modified-release tablets and capsule
Axe Federal Documents Online:Available
|
ElectronicResource GovDoc
|
2005
|
|
|
He 20. 4702 :P 87/Rev.Attach.
|
|
|
|
Guidance for industry : powder blends and finished dosage units : stratified in-process dosage unit s
HE 20.4702:P 87/REV.ATTACH.
;
Axe Federal Documents Online:Available
|
|
2003
|
|
|
He 20. 4702 :P 87rev.Attach.
|
|
|
|
Guidance for industry : powder blends and finished dosage units : stratified in-process dosage unit s
Axe Federal Documents Online:Available
|
|
2003
|
|
|
He 20. 4702 :P 92
|
|
|
|
Guidance for industry [electronic resource] : Prescription Drug Marketing Act, donation of prescripti
HE 20.4702:P 92
;
Axe Federal Documents Online:Available
|
ElectronicResource GovDoc
|
2006
|
|
Guidance for industry [electronic resource] : Prescription Drug Marketing Act, donation of prescripti
Axe Federal Documents Online:Available
|
ElectronicResource GovDoc
|
2006
|
|
|
He 20. 4702 :P 92/ 2
|
|
|
|
Guidance for industry [electronic resource] : Prescription Drug Marketing Act (PDMA) requirements, qu
HE 20.4702:P 92/2
;
Axe Federal Documents Online:Available
|
ElectronicResource GovDoc
|
2006
|
|
Guidance for industry [electronic resource] : Prescription Drug Marketing Act (PDMA) requirements, qu
Axe Federal Documents Online:Available
|
ElectronicResource GovDoc
|
2006
|
|
|
He 20. 4702 :P 92/ 3
|
|
|
|
Guidance for industry and review staff [electronic resource] : labeling for human prescription drug a
HE 20.4702:P 92/3
;
Axe Federal Documents Online:Available
|
ElectronicResource GovDoc
|
2009
|
|
Guidance for industry and review staff [electronic resource] : labeling for human prescription drug a
Axe Federal Documents Online:Available
|
ElectronicResource GovDoc
|
2009
|
|
|
He 20. 4702 :Q 1
|
|
|
|
Guidance for industry [electronic resource] : Q9 quality risk management.
HE 20.4702:Q 1
;
Axe Federal Documents Online:Available
|
ElectronicResource GovDoc
|
2006
|
|
Guidance for industry [electronic resource] : Q9 quality risk management.
Axe Federal Documents Online:Available
|
ElectronicResource GovDoc
|
2006
|
|
|
He 20. 4702 :Q 1/ 2
|
|
|
|
Guidance for industry [electronic resource] : quality systems approach to pharmaceutical CGMP regulat
HE 20.4702:Q 1/2
;
Axe Federal Documents Online:Available
|
ElectronicResource GovDoc
|
2006
|
|
Guidance for industry [electronic resource] : quality systems approach to pharmaceutical CGMP regulat
Axe Federal Documents Online:Available
|
ElectronicResource GovDoc
|
2006
|
|
|
He 20. 4702 :Q 2
|
|
|
|
Guidance for industry [electronic resource] : Q10 pharmaceutical quality system.
HE 20.4702:Q 2
;
Axe Federal Documents Online:Available
|
ElectronicResource GovDoc
|
2009
|
|
Guidance for industry [electronic resource] : Q10 pharmaceutical quality system.
Axe Federal Documents Online:Available
|
ElectronicResource GovDoc
|
2009
|
|
|
He 20. 4702 :R 11
|
|
|
|
Guidance for industry [electronic resource] : collection of race and ethnicity data in clinical trial
HE 20.4702:R 11
;
Axe Federal Documents Online:Available
|
ElectronicResource GovDoc
|
2005
|
|
Guidance for industry [electronic resource] : collection of race and ethnicity data in clinical trial
Axe Federal Documents Online:Available
|
ElectronicResource GovDoc
|
2005
|
|
|
He 20. 4702 :R 26/ 2/
|
|
|
|
Quick index to general subjects of interest related to drug regulation [electronic resource].
HE 20.4702:R 26/2/
;
Axe Federal Documents Online:Available
|
ElectronicResource GovDoc
|
1992
|
|
Quick index to general subjects of interest related to drug regulation [electronic resource].
Axe Federal Documents Online:Available
|
ElectronicResource GovDoc
|
1992
|
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