|
|
|
|
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
|
|
|
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
|
ElectronicResource GovDoc
|
1994
|
|
Dose-response information to support drug registration [electronic resource].
Axe Federal Documents Online:Available
|
ElectronicResource GovDoc
|
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
|
ElectronicResource GovDoc
|
2005
|
|
Guidance for industry [electronic resource] : estimating the maximum safe starting dose in initial cl
Axe Federal Documents Online:Available
|
ElectronicResource GovDoc
|
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
|
ElectronicResource GovDoc
|
1997
|
|
Guidance for industry [electronic resource] : nonsterile semisolid dosage forms : scale-up and postap
Axe Federal Documents Online:Available
|
ElectronicResource GovDoc
|
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
|
ElectronicResource GovDoc
|
1998
|
|
Guidance for industry [electronic resource] : providing clinical evidence of effectiveness for human
Axe Federal Documents Online:Available
|
ElectronicResource GovDoc
|
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
|
ElectronicResource GovDoc
|
2005
|
|
Guidance for industry M2 [electronic resource] : eCTD specification : questions & answers and change
Axe Federal Documents Online:Available
|
ElectronicResource GovDoc
|
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
|
ElectronicResource GovDoc
|
2003
|
|
Guidance for industry [electronic resource] : M2 eCTD : electronic common technical document specific
Axe Federal Documents Online:Available
|
ElectronicResource GovDoc
|
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
|
ElectronicResource GovDoc
|
2003
|
|
Guidance for industry [electronic resource] : part 11, electronic records : electronic signatures--sc
Axe Federal Documents Online:Available
|
ElectronicResource GovDoc
|
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
|
ElectronicResource GovDoc
|
2001
|
|
Guidance for industry [electronic resource] : 21 CFR part 11, electronic records, electronic signatur
Axe Federal Documents Online:Available
|
ElectronicResource GovDoc
|
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
|
ElectronicResource GovDoc
|
2003
|
|
Guidance for industry. Part 11, electronic records [electronic resource] : electronic signatures, sco
Axe Federal Documents Online:Available
|
ElectronicResource GovDoc
|
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
|
ElectronicResource GovDoc
|
2005
|
|
Guidance for industry [electronic resource] : M2, eCTD specification, questions & answers and change
Axe Federal Documents Online:Available
|
ElectronicResource GovDoc
|
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
|
ElectronicResource GovDoc
|
1998
|
|
Guidance for industry [electronic resource] : environmental assessment of human drug and biologics ap
Axe Federal Documents Online:Available
|
ElectronicResource GovDoc
|
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
|
ElectronicResource GovDoc
|
2003
|
|
Guidance for industry [electronic resource] : 180-day exclusivity when multiple ANDAs are submitted o
Axe Federal Documents Online:Available
|
ElectronicResource GovDoc
|
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
|
ElectronicResource GovDoc
|
2000
|
|
Guidance for industry [electronic resource] : court decisions, ANDA approvals, and 180-day exclusivit
Axe Federal Documents Online:Available
|
ElectronicResource GovDoc
|
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
|
ElectronicResource GovDoc
|
1998
|
|
Guidance for industry [electronic resource] : 180-day generic drug exclusivity under the Hatch-Waxman
Axe Federal Documents Online:Available
|
ElectronicResource GovDoc
|
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
|
ElectronicResource GovDoc
|
2006
|
|
Guidance for industry [electronic resource] : fast track drug development programs, designation, deve
Axe Federal Documents Online:Available
|
ElectronicResource GovDoc
|
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
|
ElectronicResource GovDoc
|
1999
|
|
Guidance for industry [electronic resource] : drug master files for bulk antibiotic drug substances.
Axe Federal Documents Online:Available
|
ElectronicResource GovDoc
|
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
|
ElectronicResource GovDoc
|
2001
|
|
Guidance for industry [electronic resource] : financial disclosure by clinical investigators.
Axe Federal Documents Online:Available
|
ElectronicResource GovDoc
|
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
|
ElectronicResource GovDoc
|
2002
|
|
Guidance for industry [electronic resource] : food-effect bioavailability and fed bioequivalence stud
Axe Federal Documents Online:Available
|
ElectronicResource GovDoc
|
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
|
ElectronicResource GovDoc
|
1997
|
|
Guidance for industry [electronic resource] : S2B genotoxicity, a standard battery for genotoxicity t
Axe Federal Documents Online:Available
|
ElectronicResource GovDoc
|
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
|
ElectronicResource GovDoc
|
2007
|
|
Guidance for industry [electronic resource] : testing of glycerin for diethylene glycol.
Axe Federal Documents Online:Available
|
ElectronicResource GovDoc
|
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
|
ElectronicResource GovDoc
|
1998
|
|
Good laboratory practice regulations, questions and answers [electronic resource].
Axe Federal Documents Online:Available
|
ElectronicResource GovDoc
|
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
|
ElectronicResource GovDoc
|
2005
|
|
Guidance for industry [electronic resource] : granularity document : annex to M4, organization of the
Axe Federal Documents Online:Available
|
ElectronicResource GovDoc
|
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
|
ElectronicResource GovDoc
|
2004
|
|
Guidance for industry [electronic resource] : handling and retention of BA and BE testing samples.
Axe Federal Documents Online:Available
|
ElectronicResource GovDoc
|
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
|
ElectronicResource GovDoc
|
2001
|
|
Guidance for hospitals, nursing homes and other health care facilities [electronic resource].
Axe Federal Documents Online:Available
|
ElectronicResource GovDoc
|
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
|
ElectronicResource GovDoc
|
2008
|
|
Guidance for industry [electronic resource] : hypertension indication, drug labeling for cardiovascul
Axe Federal Documents Online:Available
|
ElectronicResource GovDoc
|
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
|
ElectronicResource GovDoc
|
2006
|
|
Guidance for industry [electronic resource] : S8 immunotoxicity studies for human pharmaceuticals.
Axe Federal Documents Online:Available
|
ElectronicResource GovDoc
|
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
|
ElectronicResource GovDoc
|
2008
|
|
Guidance for industry [electronic resource] : Q3A impurities in new drug substances.
Axe Federal Documents Online:Available
|
ElectronicResource GovDoc
|
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
|
ElectronicResource GovDoc
|
2006
|
|
Guidance for industry [electronic resource] : Q3B(R2) impurities in new drug products.
Axe Federal Documents Online:Available
|
ElectronicResource GovDoc
|
2006
|
 Add Marked to Bag
Add All On Page
|
