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He 20. 4702 :P 49/Annex 6/Draft
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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
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|
2008
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Q4B evaluation and recommendation of pharmacopeoial texts for use in the ICH regions. Annex 6, Unifor
Axe Federal Documents Online:Available
|
|
2008
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|
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He 20. 4702 :P 49/Annex 7/Draft
|
|
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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
|
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Q4B evaluation and recommendation of pharmacopeoial texts for use in the ICH regions. Annex 7, Dissol
Axe Federal Documents Online:Available
|
|
2008
|
|
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He 20. 4702 :P 49/Annex 8/Draft
|
|
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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
|
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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
|
|
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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
|
|
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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
|
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2007
|
|
Guidance for industry [electronic resource] : ANDAs, pharmaceutical solid polymorphism, chemistry, ma
Axe Federal Documents Online:Available
|
|
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
|
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2006
|
|
Guidance for industry [electronic resource] : reports on the status of postmarketing study commitmen
Axe Federal Documents Online:Available
|
|
2006
|
|
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He 20. 4702 :P 84/ 4
|
|
|
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Guidance for industry [electronic resource] : potassium chloride modified-release tablets and capsule
HE 20.4702:P 84/4
;
Axe Federal Documents Online:Available
|
|
2005
|
|
Guidance for industry [electronic resource] : potassium chloride modified-release tablets and capsule
Axe Federal Documents Online:Available
|
|
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
|
|
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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
|
|
2006
|
|
Guidance for industry [electronic resource] : Prescription Drug Marketing Act, donation of prescripti
Axe Federal Documents Online:Available
|
|
2006
|
|
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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
|
|
2006
|
|
Guidance for industry [electronic resource] : Prescription Drug Marketing Act (PDMA) requirements, qu
Axe Federal Documents Online:Available
|
|
2006
|
|
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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
|
|
2009
|
|
Guidance for industry and review staff [electronic resource] : labeling for human prescription drug a
Axe Federal Documents Online:Available
|
|
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
|
|
2006
|
|
Guidance for industry [electronic resource] : Q9 quality risk management.
Axe Federal Documents Online:Available
|
|
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
|
|
2006
|
|
Guidance for industry [electronic resource] : quality systems approach to pharmaceutical CGMP regulat
Axe Federal Documents Online:Available
|
|
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
|
|
2009
|
|
Guidance for industry [electronic resource] : Q10 pharmaceutical quality system.
Axe Federal Documents Online:Available
|
|
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
|
|
2005
|
|
Guidance for industry [electronic resource] : collection of race and ethnicity data in clinical trial
Axe Federal Documents Online:Available
|
|
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
|
|
1992
|
|
Quick index to general subjects of interest related to drug regulation [electronic resource].
Axe Federal Documents Online:Available
|
|
1992
|
|
|
He 20. 4702 :R 26/ 4
|
|
|
|
Guidance for industry [electronic resource] : providing regulatory submissions in electronic format :
HE 20.4702:R 26/4
;
Axe Federal Documents Online:Available
|
|
2008
|
|
Guidance for industry [electronic resource] : providing regulatory submissions in electronic format :
Axe Federal Documents Online:Available
|
|
2008
|
|
|
He 20. 4702 :R 26/ 5
|
|
|
|
Guidance for industry [electronic resource] : providing regulatory submissions in electronic format,
HE 20.4702:R 26/5
;
Axe Federal Documents Online:Available
|
|
2007
|
|
Guidance for industry [electronic resource] : providing regulatory submissions in electronic format,
Axe Federal Documents Online:Available
|
|
2007
|
|
|
He 20. 4702 :R 26/ 6
|
|
|
|
Guidance for industry [electronic resource] : providing regulatory submissions in electronic format,
HE 20.4702:R 26/6
;
Axe Federal Documents Online:Available
|
|
2005
|
|
Guidance for industry [electronic resource] : providing regulatory submissions in electronic format,
Axe Federal Documents Online:Available
|
|
2005
|
|
|
He 20. 4702 :R 26/ 7
|
|
|
|
Guidance for industry [electronic resource] : providing regulatory submissions in electronic format,
HE 20.4702:R 26/7
;
Axe Federal Documents Online:Available
|
|
2001
|
|
Guidance for industry [electronic resource] : providing regulatory submissions in electronic format,
Axe Federal Documents Online:Available
|
|
2001
|
|
|
He 20. 4702 :R 26/ 8
|
|
|
|
Guidance for industry : providing regulatory submissions in electronic format, general considerations
HE 20.4702:R 26/8
;
Axe Federal Documents Online:Available
|
|
1999
|
|
Guidance for industry : providing regulatory submissions in electronic format, general considerations
Axe Federal Documents Online:Available
|
|
1999
|
|
|
He 20. 4702 :R 26/ 998
|
|
|
|
Drug registration and listing instructions [electronic resource] / Center for Drug Evaluation and Res
HE 20.4702:R 26/998
;
Axe Federal Documents Online:Available
|
|
1998
|
|
Drug registration and listing instructions [electronic resource] / Center for Drug Evaluation and Res
Axe Federal Documents Online:Available
|
|
1998
|
|
|
He 20. 4702 :R 31/ 3
|
|
|
|
Guidance for industry [electronic resource] : classifying resubmissions in response to action letters
HE 20.4702:R 31/3
;
Axe Federal Documents Online:Available
|
|
1998
|
|
Guidance for industry [electronic resource] : classifying resubmissions in response to action letters
Axe Federal Documents Online:Available
|
|
1998
|
|
|
He 20. 4702 :R 31/Rev. 1
|
|
|
|
Guidance for industry [electronic resource] : fast track drug development programs, designation, deve
HE 20.4702:R 31/REV.1
;
Axe Federal Documents Online:Available
|
|
2004
|
|
Guidance for industry [electronic resource] : fast track drug development programs, designation, deve
Axe Federal Documents Online:Available
|
|
2004
|
|
|
He 20. 4702 :R 44
|
|
|
|
Guidance for industry [electronic resource] : protecting the rights, safety and welfare of study subj
HE 20.4702:R 44
;
Axe Federal Documents Online:Available
|
|
2007
|
|
Guidance for industry [electronic resource] : protecting the rights, safety and welfare of study subj
Axe Federal Documents Online:Available
|
|
2007
|
|
|
He 20. 4702 :R 49
|
|
|
|
Guidance for industry [electronic resource] : development and use of risk minimization action plans.
HE 20.4702:R 49
;
Axe Federal Documents Online:Available
|
|
2005
|
|
Guidance for industry [electronic resource] : development and use of risk minimization action plans.
Axe Federal Documents Online:Available
|
|
2005
|
|
|
He 20. 4702 :R 49/ 2
|
|
|
|
Guidance for industry [electronic resource] : premarketing risk assessment.
HE 20.4702:R 49/2
;
Axe Federal Documents Online:Available
|
|
2005
|
|
Guidance for industry [electronic resource] : premarketing risk assessment.
Axe Federal Documents Online:Available
|
|
2005
|
|
|
He 20. 4702 :R 49/ 4/Draft
|
|
|
|
Guidance for industry [electronic resource] : brief summary : disclosing risk information in consumer
HE 20.4702:R 49/4/DRAFT
;
Axe Federal Documents Online:Available
|
|
2004
|
|
Guidance for industry [electronic resource] : brief summary : disclosing risk information in consumer
Axe Federal Documents Online:Available
|
|
2004
|
|
|
He 20. 4702 :R 49/ 5/Draft
|
|
|
|
Guidance for industry [electronic resource] : presenting risk information in prescription drug and me
HE 20.4702:R 49/5/DRAFT
;
Axe Federal Documents Online:Available
|
|
2009
|
|
Guidance for industry [electronic resource] : presenting risk information in prescription drug and me
Axe Federal Documents Online:Available
|
|
2009
|
|
|
He 20. 4702 :Sa 1
|
|
|
|
Guidance for industry [electronic resource] : nonclinical studies for the safety evaluation of pharma
HE 20.4702:SA 1
;
Axe Federal Documents Online:Available
|
|
2005
|
|
Guidance for industry [electronic resource] : nonclinical studies for the safety evaluation of pharma
Axe Federal Documents Online:Available
|
|
2005
|
|
|
He 20. 4702 :Sa 1/ 2
|
|
|
|
Guidance for industry [electronic resource] : S7A safety pharmacology studies for human pharmaceutica
HE 20.4702:SA 1/2
;
Axe Federal Documents Online:Available
|
|
2001
|
|
Guidance for industry [electronic resource] : S7A safety pharmacology studies for human pharmaceutica
Axe Federal Documents Online:Available
|
|
2001
|
|
|
He 20. 4702 :Sa 1/ 3
|
|
|
|
Guidance for industry [electronic resource] : S6 preclinical safety evaluation of biotechnology-deriv
HE 20.4702:SA 1/3
;
Axe Federal Documents Online:Available
|
|
1997
|
|
Guidance for industry [electronic resource] : S6 preclinical safety evaluation of biotechnology-deriv
Axe Federal Documents Online:Available
|
|
1997
|
|
|
He 20. 4702 :Sa 1/ 4
|
|
|
|
Guidance [electronic resource] : drug safety information, FDA's communication to the public.
HE 20.4702:SA 1/4
;
Axe Federal Documents Online:Available
|
|
2007
|
|
Guidance [electronic resource] : drug safety information, FDA's communication to the public.
Axe Federal Documents Online:Available
|
|
2007
|
|
|
He 20. 4702 :Sa 1/ 5
|
|
|
|
Guidance for industry [electronic resource] : M3 nonclinical safety studies for the conduct of human
HE 20.4702:SA 1/5
;
Axe Federal Documents Online:Available
|
|
1997
|
|
Guidance for industry [electronic resource] : M3 nonclinical safety studies for the conduct of human
Axe Federal Documents Online:Available
|
|
1997
|
|
|
He 20. 4702 :Sa 1/ 6
|
|
|
|
Guidance for industry [electronic resource] : safety testing of drug metabolites.
HE 20.4702:SA 1/6
;
Axe Federal Documents Online:Available
|
|
2008
|
|
Guidance for industry [electronic resource] : safety testing of drug metabolites.
Axe Federal Documents Online:Available
|
|
2008
|
|
|
He 20. 4702 :Sa 1/ 7
|
|
|
|
Guidance for industry [electronic resource] : nonclinical safety evaluation of drug or biologic combi
HE 20.4702:SA 1/7
;
Axe Federal Documents Online:Available
|
|
2006
|
|
Guidance for industry [electronic resource] : nonclinical safety evaluation of drug or biologic combi
Axe Federal Documents Online:Available
|
|
2006
|
|
|
He 20. 4702 :Sa 1/ 8/Draft
|
|
|
|
Guidance for industry and review staff [electronic resource] : nonclinical safety evaluation of refor
HE 20.4702:SA 1/8/DRAFT
;
Axe Federal Documents Online:Available
|
|
2008
|
|
Guidance for industry and review staff [electronic resource] : nonclinical safety evaluation of refor
Axe Federal Documents Online:Available
|
|
2008
|
|
|
He 20. 4702 :Sca 4
|
|
|
|
Guidance for industry [electronic resource] : SUPAC-IR/MR : immediate release and modified release so
HE 20.4702:SCA 4
;
Axe Federal Documents Online:Available
|
|
1999
|
|
Guidance for industry [electronic resource] : SUPAC-IR/MR : immediate release and modified release so
Axe Federal Documents Online:Available
|
|
1999
|
|
|
He 20. 4702 :Sca 4/ 2
|
|
|
|
Guidance for industry [electronic resource] : SUPAC-MR : modified release solid oral dosage forms : s
HE 20.4702:SCA 4/2
;
Axe Federal Documents Online:Available
|
|
1997
|
|
Guidance for industry [electronic resource] : SUPAC-MR : modified release solid oral dosage forms : s
Axe Federal Documents Online:Available
|
|
1997
|
|
|
He 20. 4702 :Sca 4/ 3/Draft
|
|
|
|
Guidance for industry [electronic resource] : SUPAC-SS : nonsterile semisolid dosage forms : manufact
HE 20.4702:SCA 4/3/DRAFT
;
Axe Federal Documents Online:Available
|
|
1998
|
|
Guidance for industry [electronic resource] : SUPAC-SS : nonsterile semisolid dosage forms : manufact
Axe Federal Documents Online:Available
|
|
1998
|
|
|
He 20. 4702 :Si 6/Draft
|
|
|
|
Guidance for industry [electronic resource] : acute bacterial sinusitis, developing drugs for treatme
HE 20.4702:SI 6/DRAFT
;
Axe Federal Documents Online:Available
|
|
2007
|
|
Guidance for industry [electronic resource] : acute bacterial sinusitis, developing drugs for treatme
Axe Federal Documents Online:Available
|
|
2007
|
|
|
He 20. 4702 :So 4
|
|
|
|
Guidance for industry [electronic resource] : residual solvents in drug products marketed in the Unit
HE 20.4702:SO 4
;
Axe Federal Documents Online:Available
|
|
2009
|
|
Guidance for industry [electronic resource] : residual solvents in drug products marketed in the Unit
Axe Federal Documents Online:Available
|
|
2009
|
|
|
He 20. 4702 :Sp 3
|
|
|
|
Studies in support of special populations, geriatrics [electronic resource].
HE 20.4702:SP 3
;
Axe Federal Documents Online:Available
|
|
1994
|
|
Studies in support of special populations, geriatrics [electronic resource].
Axe Federal Documents Online:Available
|
|
1994
|
|
|
He 20. 4702 :St 1
|
|
|
|
Guidance for industry [electronic resource] : Q1E evaluation of stability data.
HE 20.4702:ST 1
;
Axe Federal Documents Online:Available
|
|
2004
|
|
Guidance for industry [electronic resource] : Q1E evaluation of stability data.
Axe Federal Documents Online:Available
|
|
2004
|
|
|
He 20. 4702 :St 1/ 2
|
|
|
|
Guidance for industry [electronic resource] : Q1A(R2) stability testing of new drug substances and pr
HE 20.4702:ST 1/2
;
Axe Federal Documents Online:Available
|
|
2003
|
|
Guidance for industry [electronic resource] : Q1A(R2) stability testing of new drug substances and pr
Axe Federal Documents Online:Available
|
|
2003
|
|
|
He 20. 4702 :St 1/ 3
|
|
|
|
Guidance for industry [electronic resource] : Q1C stability testing for new dosage forms.
HE 20.4702:ST 1/3
;
Axe Federal Documents Online:Available
|
|
1996
|
|
Guidance for industry [electronic resource] : Q1C stability testing for new dosage forms.
Axe Federal Documents Online:Available
|
|
1996
|
|
|
He 20. 4702 :St 2
|
|
|
|
Guidance for industry [electronic resource] : E9 statistical principles for clinical trials.
HE 20.4702:ST 2
;
Axe Federal Documents Online:Available
|
|
1998
|
|
Guidance for industry [electronic resource] : E9 statistical principles for clinical trials.
Axe Federal Documents Online:Available
|
|
1998
|
|
|
He 20. 4702 :St 3
|
|
|
|
Guidance for industry [electronic resource] : sterile drug products produced by aseptic processing, c
HE 20.4702:ST 3
;
Axe Federal Documents Online:Available
|
|
2004
|
|
Guidance for industry [electronic resource] : sterile drug products produced by aseptic processing, c
Axe Federal Documents Online:Available
|
|
2004
|
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