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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   Electronic Book 1995
      Guidance for industry : immediate release solid oral dosage forms : scale-up and postapproval changes Axe Federal Documents Online:Available   Electronic Book 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
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