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He 20. 4702 :D 63/ 3
|
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Guidance for industry [electronic resource] : dissolution testing of immediate release solid oral dos
HE 20.4702:D 63/3
;
Axe Federal Documents Online:Available
|
|
1997
|
|
Guidance for industry [electronic resource] : dissolution testing of immediate release solid oral dos
Axe Federal Documents Online:Available
|
|
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
|
|
1987
|
|
Guideline for submitting documentation for the manufacture of and controls for drug products [electro
Axe Federal Documents Online:Available
|
|
1987
|
|
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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
|
|
1987
|
|
Guideline for submitting supporting documentation in drug applications for the manufacture of drug su
Axe Federal Documents Online:Available
|
|
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
|
|
1997
|
|
Guidance for industry [electronic resource] : expiration dating and stability testing of solid oral d
Axe Federal Documents Online:Available
|
|
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
|
|
2011
|
|
Guidance for industry - dosage delivery devices for OTC liquid drug products [electronic resource].
Axe Federal Documents Online:Available
|
|
2011
|
|
|
He 20. 4702 :D 74/ 3
|
|
|
|
Dose-response information to support drug registration [electronic resource].
HE 20.4702:D 74/3
;
Axe Federal Documents Online:Available
|
|
1994
|
|
Dose-response information to support drug registration [electronic resource].
Axe Federal Documents Online:Available
|
|
1994
|
|
|
He 20. 4702 :D 74/ 4
|
|
|
|
Guidance for industry [electronic resource] : estimating the maximum safe starting dose in initial cl
HE 20.4702:D 74/4
;
Axe Federal Documents Online:Available
|
|
2005
|
|
Guidance for industry [electronic resource] : estimating the maximum safe starting dose in initial cl
Axe Federal Documents Online:Available
|
|
2005
|
|
|
He 20. 4702 :D 74/ 5
|
|
|
|
Guidance for industry : immediate release solid oral dosage forms : scale-up and postapproval changes
HE 20.4702:D 74/5
;
Axe Federal Documents Online:Available
|
|
1995
|
|
Guidance for industry : immediate release solid oral dosage forms : scale-up and postapproval changes
Axe Federal Documents Online:Available
|
|
1995
|
|
|
He 20. 4702 :D 74/ 6
|
|
|
|
Guidance for industry [electronic resource] : nonsterile semisolid dosage forms : scale-up and postap
HE 20.4702:D 74/6
;
Axe Federal Documents Online:Available
|
|
1997
|
|
Guidance for industry [electronic resource] : nonsterile semisolid dosage forms : scale-up and postap
Axe Federal Documents Online:Available
|
|
1997
|
|
|
He 20. 4702 :Ef 3
|
|
|
|
Guidance for industry [electronic resource] : providing clinical evidence of effectiveness for human
HE 20.4702:EF 3
;
Axe Federal Documents Online:Available
|
|
1998
|
|
Guidance for industry [electronic resource] : providing clinical evidence of effectiveness for human
Axe Federal Documents Online:Available
|
|
1998
|
|
|
He 20. 4702 :El 2
|
|
|
|
Guidance for industry M2 [electronic resource] : eCTD specification : questions & answers and change
HE 20.4702:EL 2
;
Axe Federal Documents Online:Available
|
|
2005
|
|
Guidance for industry M2 [electronic resource] : eCTD specification : questions & answers and change
Axe Federal Documents Online:Available
|
|
2005
|
|
|
He 20. 4702 :El 2/ 2
|
|
|
|
Guidance for industry [electronic resource] : M2 eCTD : electronic common technical document specific
HE 20.4702:EL 2/2
;
Axe Federal Documents Online:Available
|
|
2003
|
|
Guidance for industry [electronic resource] : M2 eCTD : electronic common technical document specific
Axe Federal Documents Online:Available
|
|
2003
|
|
|
He 20. 4702 :El 2/ 3
|
|
|
|
Guidance for industry [electronic resource] : part 11, electronic records : electronic signatures--sc
HE 20.4702:EL 2/3
;
Axe Federal Documents Online:Available
|
|
2003
|
|
Guidance for industry [electronic resource] : part 11, electronic records : electronic signatures--sc
Axe Federal Documents Online:Available
|
|
2003
|
|
|
He 20. 4702 :El 2/ 4
|
|
|
|
Guidance for industry [electronic resource] : 21 CFR part 11, electronic records, electronic signatur
HE 20.4702:EL 2/4
;
Axe Federal Documents Online:Available
|
|
2001
|
|
Guidance for industry [electronic resource] : 21 CFR part 11, electronic records, electronic signatur
Axe Federal Documents Online:Available
|
|
2001
|
|
|
He 20. 4702 :El 2/ 5
|
|
|
|
Guidance for industry. Part 11, electronic records [electronic resource] : electronic signatures, sco
HE 20.4702:EL 2/5
;
Axe Federal Documents Online:Available
|
|
2003
|
|
Guidance for industry. Part 11, electronic records [electronic resource] : electronic signatures, sco
Axe Federal Documents Online:Available
|
|
2003
|
|
|
He 20. 4702 :El 2/ 6
|
|
|
|
Guidance for industry [electronic resource] : M2, eCTD specification, questions & answers and change
HE 20.4702:EL 2/6
;
Axe Federal Documents Online:Available
|
|
2005
|
|
Guidance for industry [electronic resource] : M2, eCTD specification, questions & answers and change
Axe Federal Documents Online:Available
|
|
2005
|
|
|
He 20. 4702 :En 9
|
|
|
|
Guidance for industry [electronic resource] : environmental assessment of human drug and biologics ap
HE 20.4702:EN 9
;
Axe Federal Documents Online:Available
|
|
1998
|
|
Guidance for industry [electronic resource] : environmental assessment of human drug and biologics ap
Axe Federal Documents Online:Available
|
|
1998
|
|
|
He 20. 4702 :Ex 2
|
|
|
|
Guidance for industry [electronic resource] : 180-day exclusivity when multiple ANDAs are submitted o
HE 20.4702:EX 2
;
Axe Federal Documents Online:Available
|
|
2003
|
|
Guidance for industry [electronic resource] : 180-day exclusivity when multiple ANDAs are submitted o
Axe Federal Documents Online:Available
|
|
2003
|
|
|
He 20. 4702 :Ex 2/ 2
|
|
|
|
Guidance for industry [electronic resource] : court decisions, ANDA approvals, and 180-day exclusivit
HE 20.4702:EX 2/2
;
Axe Federal Documents Online:Available
|
|
2000
|
|
Guidance for industry [electronic resource] : court decisions, ANDA approvals, and 180-day exclusivit
Axe Federal Documents Online:Available
|
|
2000
|
|
|
He 20. 4702 :Ex 2/ 3
|
|
|
|
Guidance for industry [electronic resource] : 180-day generic drug exclusivity under the Hatch-Waxman
HE 20.4702:EX 2/3
;
Axe Federal Documents Online:Available
|
|
1998
|
|
Guidance for industry [electronic resource] : 180-day generic drug exclusivity under the Hatch-Waxman
Axe Federal Documents Online:Available
|
|
1998
|
|
|
He 20. 4702 :F 26
|
|
|
|
Guidance for industry [electronic resource] : fast track drug development programs, designation, deve
HE 20.4702:F 26
;
Axe Federal Documents Online:Available
|
|
2006
|
|
Guidance for industry [electronic resource] : fast track drug development programs, designation, deve
Axe Federal Documents Online:Available
|
|
2006
|
|
|
He 20. 4702 :F 47
|
|
|
|
Guidance for industry [electronic resource] : drug master files for bulk antibiotic drug substances.
HE 20.4702:F 47
;
Axe Federal Documents Online:Available
|
|
1999
|
|
Guidance for industry [electronic resource] : drug master files for bulk antibiotic drug substances.
Axe Federal Documents Online:Available
|
|
1999
|
|
|
He 20. 4702 :F 49
|
|
|
|
Guidance for industry [electronic resource] : financial disclosure by clinical investigators.
HE 20.4702:F 49
;
Axe Federal Documents Online:Available
|
|
2001
|
|
Guidance for industry [electronic resource] : financial disclosure by clinical investigators.
Axe Federal Documents Online:Available
|
|
2001
|
|
|
He 20. 4702 :F 73
|
|
|
|
Guidance for industry [electronic resource] : food-effect bioavailability and fed bioequivalence stud
HE 20.4702:F 73
;
Axe Federal Documents Online:Available
|
|
2002
|
|
Guidance for industry [electronic resource] : food-effect bioavailability and fed bioequivalence stud
Axe Federal Documents Online:Available
|
|
2002
|
|
|
He 20. 4702 :G 28/ 4
|
|
|
|
Guidance for industry [electronic resource] : S2B genotoxicity, a standard battery for genotoxicity t
HE 20.4702:G 28/4
;
Axe Federal Documents Online:Available
|
|
1997
|
|
Guidance for industry [electronic resource] : S2B genotoxicity, a standard battery for genotoxicity t
Axe Federal Documents Online:Available
|
|
1997
|
|
|
He 20. 4702 :G 52
|
|
|
|
Guidance for industry [electronic resource] : testing of glycerin for diethylene glycol.
HE 20.4702:G 52
;
Axe Federal Documents Online:Available
|
|
2007
|
|
Guidance for industry [electronic resource] : testing of glycerin for diethylene glycol.
Axe Federal Documents Online:Available
|
|
2007
|
|
|
He 20. 4702 :G 59
|
|
|
|
Good laboratory practice regulations, questions and answers [electronic resource].
HE 20.4702:G 59
;
Axe Federal Documents Online:Available
|
|
1998
|
|
Good laboratory practice regulations, questions and answers [electronic resource].
Axe Federal Documents Online:Available
|
|
1998
|
|
|
He 20. 4702 :G 76
|
|
|
|
Guidance for industry [electronic resource] : granularity document : annex to M4, organization of the
HE 20.4702:G 76
;
Axe Federal Documents Online:Available
|
|
2005
|
|
Guidance for industry [electronic resource] : granularity document : annex to M4, organization of the
Axe Federal Documents Online:Available
|
|
2005
|
|
|
He 20. 4702 :H 19
|
|
|
|
Guidance for industry [electronic resource] : handling and retention of BA and BE testing samples.
HE 20.4702:H 19
;
Axe Federal Documents Online:Available
|
|
2004
|
|
Guidance for industry [electronic resource] : handling and retention of BA and BE testing samples.
Axe Federal Documents Online:Available
|
|
2004
|
|
|
He 20. 4702 :H 79
|
|
|
|
Guidance for hospitals, nursing homes and other health care facilities [electronic resource].
HE 20.4702:H 79
;
Axe Federal Documents Online:Available
|
|
2001
|
|
Guidance for hospitals, nursing homes and other health care facilities [electronic resource].
Axe Federal Documents Online:Available
|
|
2001
|
|
|
He 20. 4702 :H 99
|
|
|
|
Guidance for industry [electronic resource] : hypertension indication, drug labeling for cardiovascul
HE 20.4702:H 99
;
Axe Federal Documents Online:Available
|
|
2008
|
|
Guidance for industry [electronic resource] : hypertension indication, drug labeling for cardiovascul
Axe Federal Documents Online:Available
|
|
2008
|
|
|
He 20. 4702 :Im 6
|
|
|
|
Guidance for industry [electronic resource] : S8 immunotoxicity studies for human pharmaceuticals.
HE 20.4702:IM 6
;
Axe Federal Documents Online:Available
|
|
2006
|
|
Guidance for industry [electronic resource] : S8 immunotoxicity studies for human pharmaceuticals.
Axe Federal Documents Online:Available
|
|
2006
|
|
|
He 20. 4702 :Im 7
|
|
|
|
Guidance for industry [electronic resource] : Q3A impurities in new drug substances.
HE 20.4702:IM 7
;
Axe Federal Documents Online:Available
|
|
2008
|
|
Guidance for industry [electronic resource] : Q3A impurities in new drug substances.
Axe Federal Documents Online:Available
|
|
2008
|
|
|
He 20. 4702 :Im 7/ 2
|
|
|
|
Guidance for industry [electronic resource] : Q3B(R2) impurities in new drug products.
HE 20.4702:IM 7/2
;
Axe Federal Documents Online:Available
|
|
2006
|
|
Guidance for industry [electronic resource] : Q3B(R2) impurities in new drug products.
Axe Federal Documents Online:Available
|
|
2006
|
|
|
He 20. 4702 :Im 7/ 3
|
|
|
|
Guidance for industry [electronic resource] : Q3C impurities, residual solvents.
HE 20.4702:IM 7/3
;
Axe Federal Documents Online:Available
|
|
1997
|
|
Guidance for industry [electronic resource] : Q3C impurities, residual solvents.
Axe Federal Documents Online:Available
|
|
1997
|
|
|
He 20. 4702 :Im 7/ 4
|
|
|
|
Guidance for industry [electronic resource] : ANDAs, impurities in drug products.
HE 20.4702:IM 7/4
;
Axe Federal Documents Online:Available
|
|
2005
|
|
Guidance for industry [electronic resource] : ANDAs, impurities in drug products.
Axe Federal Documents Online:Available
|
|
2005
|
|
|
He 20. 4702 :Im 7/ 5
|
|
|
|
Guidance for industry [electronic resource] : ANDAs, impurities in drug substances.
HE 20.4702:IM 7/5
;
Axe Federal Documents Online:Available
|
|
2009
|
|
Guidance for industry [electronic resource] : ANDAs, impurities in drug substances.
Axe Federal Documents Online:Available
|
|
2009
|
|
|
He 20. 4702 :Im 7/ 6
|
|
|
|
Guidance for industry [electronic resource] : NDA's : impurities in drug substances.
HE 20.4702:IM 7/6
;
Axe Federal Documents Online:Available
|
|
2000
|
|
Guidance for industry [electronic resource] : NDA's : impurities in drug substances.
Axe Federal Documents Online:Available
|
|
2000
|
|
|
He 20. 4702 :Im 9
|
|
|
|
Guidance for industry [electronic resource] : immunotoxicology evaluation of investigational new drug
HE 20.4702:IM 9
;
Axe Federal Documents Online:Available
|
|
2002
|
|
Guidance for industry [electronic resource] : immunotoxicology evaluation of investigational new drug
Axe Federal Documents Online:Available
|
|
2002
|
|
|
He 20. 4702 :In 3/ 2
|
|
|
|
Guidance for industry [electronic resource] : information program on clinical trials for serious or l
HE 20.4702:IN 3/2
;
Axe Federal Documents Online:Available
|
|
2002
|
|
Guidance for industry [electronic resource] : information program on clinical trials for serious or l
Axe Federal Documents Online:Available
|
|
2002
|
|
|
He 20. 4702 :In 4/Draft
|
|
|
|
Guidance for industry [electronic resource] : metered dose inhaler (MDI) and dry powder inhaler (DPI)
HE 20.4702:IN 4/DRAFT
;
Axe Federal Documents Online:Available
|
|
1998
|
|
Guidance for industry [electronic resource] : metered dose inhaler (MDI) and dry powder inhaler (DPI)
Axe Federal Documents Online:Available
|
|
1998
|
|
|
He 20. 4702 :In 8
|
|
|
|
Guidance for industry [electronic resource] : content and format of investigational new drug applicat
HE 20.4702:IN 8
;
Axe Federal Documents Online:Available
|
|
1995
|
|
Guidance for industry [electronic resource] : content and format of investigational new drug applicat
Axe Federal Documents Online:Available
|
|
1995
|
|
|
He 20. 4702 :In 8/ 2
|
|
|
|
Guidance for industry [electronic resource] : integrated summaries of effectiveness and safety : loca
HE 20.4702:IN 8/2
;
Axe Federal Documents Online:Available
|
|
2009
|
|
Guidance for industry [electronic resource] : integrated summaries of effectiveness and safety : loca
Axe Federal Documents Online:Available
|
|
2009
|
|
|
He 20. 4702 :In 8/ 3
|
|
|
|
Guidance for industry [electronic resource] : IND exemptions for studies of lawfully marketed drug or
HE 20.4702:IN 8/3
;
Axe Federal Documents Online:Available
|
|
2004
|
|
Guidance for industry [electronic resource] : IND exemptions for studies of lawfully marketed drug or
Axe Federal Documents Online:Available
|
|
2004
|
|
|
He 20. 4702 :In 8/ 4
|
|
|
|
Guidance for industry [electronic resource] : INDs for phase 2 and phase 3 studies, chemistry, manufa
HE 20.4702:IN 8/4
;
Axe Federal Documents Online:Available
|
|
2003
|
|
Guidance for industry [electronic resource] : INDs for phase 2 and phase 3 studies, chemistry, manufa
Axe Federal Documents Online:Available
|
|
2003
|
|
|
He 20. 4702 :In 8/ 5
|
|
|
|
Guidance for industry, investigators, and reviewers [electronic resource] : exploratory IND studies.
HE 20.4702:IN 8/5
;
Axe Federal Documents Online:Available
|
|
2006
|
|
Guidance for industry, investigators, and reviewers [electronic resource] : exploratory IND studies.
Axe Federal Documents Online:Available
|
|
2006
|
|
|
He 20. 4702 :In 8/ 6
|
|
|
|
Guidance for industry [electronic resource] : IND meetings for human drugs and biologics, chemistry,
HE 20.4702:IN 8/6
;
Axe Federal Documents Online:Available
|
|
2001
|
|
Guidance for industry [electronic resource] : IND meetings for human drugs and biologics, chemistry,
Axe Federal Documents Online:Available
|
|
2001
|
|
|
He 20. 4702 :In 8/ 7
|
|
|
|
Guidance for industry, q & a [electronic resource] : content and format of INDs for phase 1 studies o
HE 20.4702:IN 8/7
;
Axe Federal Documents Online:Available
|
|
2000
|
|
Guidance for industry, q & a [electronic resource] : content and format of INDs for phase 1 studies o
Axe Federal Documents Online:Available
|
|
2000
|
|
|
He 20. 4702 :L 11
|
|
|
|
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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