|
|
|
|
He 20. 4802 :C 49
|
|
|
|
Guidance for industry [electronic resource] : an acceptable circular of information for the use of hu
HE 20.4802:C 49
;
Axe Federal Documents Online:Available
|
ElectronicResource GovDoc
|
2003
|
|
Guidance for industry [electronic resource] : an acceptable circular of information for the use of hu
Axe Federal Documents Online:Available
|
ElectronicResource GovDoc
|
2003
|
|
|
He 20. 4802 :C 61
|
|
|
|
Guidance for clinical trial sponsors [electronic resource] : establishment and operation of clinical
HE 20.4802:C 61
;
Axe Federal Documents Online:Available
|
ElectronicResource GovDoc
|
2006
|
|
Guidance for clinical trial sponsors [electronic resource] : establishment and operation of clinical
Axe Federal Documents Online:Available
|
ElectronicResource GovDoc
|
2006
|
|
|
He 20. 4802 :C 61/ 2
|
|
|
|
Guidance for industry and clinical investigators [electronic resource] : the use of clinical holds fo
HE 20.4802:C 61/2
;
Axe Federal Documents Online:Available
|
ElectronicResource GovDoc
|
2004
|
|
Guidance for industry and clinical investigators [electronic resource] : the use of clinical holds fo
Axe Federal Documents Online:Available
|
ElectronicResource GovDoc
|
2004
|
|
|
He 20. 4802 :C 61/ 3
|
|
|
|
Guidance for clinical trial sponsors [electronic resource] : on the establishment and operation of cl
HE 20.4802:C 61/3
;
Axe Federal Documents Online:Available
|
ElectronicResource GovDoc
|
2001
|
|
Guidance for clinical trial sponsors [electronic resource] : on the establishment and operation of cl
Axe Federal Documents Online:Available
|
ElectronicResource GovDoc
|
2001
|
|
|
He 20. 4802 :C 67
|
|
|
|
Guidance for industry [electronic resource] : recommendations for collecting red blood cells by autom
HE 20.4802:C 67
;
Axe Federal Documents Online:Available
|
ElectronicResource GovDoc
|
2001
|
|
Guidance for industry [electronic resource] : recommendations for collecting red blood cells by autom
Axe Federal Documents Online:Available
|
ElectronicResource GovDoc
|
2001
|
|
|
He 20. 4802 :C 73/ 2
|
|
|
|
Guidance for industry [electronic resource] : computerized systems used in clinical trials.
HE 20.4802:C 73/2
;
Axe Federal Documents Online:Available
|
ElectronicResource GovDoc
|
1999
|
|
Guidance for industry [electronic resource] : computerized systems used in clinical trials.
Axe Federal Documents Online:Available
|
ElectronicResource GovDoc
|
1999
|
|
|
He 20. 4802 :C 73/ 3/Draft
|
|
|
|
Guidance for industry : complementary and alternative medicine products and their regulation by the F
HE 20.4802:C 73/3/DRAFT
;
Axe Federal Documents Online:Available
|
|
2006
|
|
Guidance for industry : complementary and alternative medicine products and their regulation by the F
Axe Federal Documents Online:Available
|
|
2006
|
|
|
He 20. 4802 :C 73/ 4
|
|
|
|
Guidance for industry [electronic resource] : compliance with 21 CFR part 1271.150(c)(1), manufacturi
HE 20.4802:C 73/4
;
Axe Federal Documents Online:Available
|
ElectronicResource GovDoc
|
2006
|
|
Guidance for industry [electronic resource] : compliance with 21 CFR part 1271.150(c)(1), manufacturi
Axe Federal Documents Online:Available
|
ElectronicResource GovDoc
|
2006
|
|
|
He 20. 4802 :C 73/ 5
|
|
|
|
Demonstration of comparability of human biological products, incuding therapeutic biotechnology-deri
HE 20.4802:C 73/5
;
Axe Federal Documents Online:Available
|
ElectronicResource GovDoc
|
1996
|
|
Demonstration of comparability of human biological products, incuding therapeutic biotechnology-deri
Axe Federal Documents Online:Available
|
ElectronicResource GovDoc
|
1996
|
|
|
He 20. 4802 :C 73/ 6
|
|
|
|
Guidance for industry [electronic resource] : M4S, the CTD, safety appendices.
HE 20.4802:C 73/6
;
Axe Federal Documents Online:Available
|
ElectronicResource GovDoc
|
2001
|
|
Guidance for industry [electronic resource] : M4S, the CTD, safety appendices.
Axe Federal Documents Online:Available
|
ElectronicResource GovDoc
|
2001
|
|
|
He 20. 4802 :C 73/ 7
|
|
|
|
Guidance for industry [electronic resource] : "computer crossmatch" (electronic based testing for the
HE 20.4802:C 73/7
;
Axe Federal Documents Online:Available
|
ElectronicResource GovDoc
|
2007
|
|
Guidance for industry [electronic resource] : "computer crossmatch" (electronic based testing for the
Axe Federal Documents Online:Available
|
ElectronicResource GovDoc
|
2007
|
|
|
He 20. 4802 :C 74
|
|
|
|
Guidance for the public, FDA advisory committee members, and FDA staff on procedures for determining
HE 20.4802:C 74
;
Axe Federal Documents Online:Available
|
ElectronicResource GovDoc
|
2008
|
|
Guidance for the public, FDA advisory committee members, and FDA staff on procedures for determining
Axe Federal Documents Online:Available
|
ElectronicResource GovDoc
|
2008
|
|
|
He 20. 4802 :C 74/ 2
|
|
|
|
Guidance for industry [electronic resource] : class II special controls guidance document : in vitro
HE 20.4802:C 74/2
;
Axe Federal Documents Online:Available
|
ElectronicResource GovDoc
|
2007
|
|
Guidance for industry [electronic resource] : class II special controls guidance document : in vitro
Axe Federal Documents Online:Available
|
ElectronicResource GovDoc
|
2007
|
|
|
He 20. 4802 :C 76
|
|
|
|
Guidance for industry [electronic resource] : container and closure system integrity testing in lieu
HE 20.4802:C 76
;
Axe Federal Documents Online:Available
|
ElectronicResource GovDoc
|
2008
|
|
Guidance for industry [electronic resource] : container and closure system integrity testing in lieu
Axe Federal Documents Online:Available
|
ElectronicResource GovDoc
|
2008
|
|
|
He 20. 4802 :C 76/ 2
|
|
|
|
Guidance for industry [electronic resource] : implementing a collection program for source plasma con
HE 20.4802:C 76/2
;
Axe Federal Documents Online:Available
|
ElectronicResource GovDoc
|
2006
|
|
Guidance for industry [electronic resource] : implementing a collection program for source plasma con
Axe Federal Documents Online:Available
|
ElectronicResource GovDoc
|
2006
|
|
|
He 20. 4802 :C 76/ 3
|
|
|
|
Guidance for industry on the content and format of chemistry, manufacturing and controls information
HE 20.4802:C 76/3
;
Axe Federal Documents Online:Available
|
ElectronicResource GovDoc
|
1999
|
|
Guidance for industry on the content and format of chemistry, manufacturing and controls information
Axe Federal Documents Online:Available
|
ElectronicResource GovDoc
|
1999
|
|
|
He 20. 4802 :C 81
|
|
|
|
Guidance for industry [electronic resource] : class II special controls guidance document : cord bloo
HE 20.4802:C 81
;
Axe Federal Documents Online:Available
|
ElectronicResource GovDoc
|
2007
|
|
Guidance for industry [electronic resource] : class II special controls guidance document : cord bloo
Axe Federal Documents Online:Available
|
ElectronicResource GovDoc
|
2007
|
|
|
He 20. 4802 :C 81/ 2
|
|
|
|
Guidance for industry [electronic resource] : minimally manipulated, unrelated, allogeneic placental/
HE 20.4802:C 81/2
;
Axe Federal Documents Online:Available
|
ElectronicResource GovDoc
|
2006
|
|
Guidance for industry [electronic resource] : minimally manipulated, unrelated, allogeneic placental/
Axe Federal Documents Online:Available
|
ElectronicResource GovDoc
|
2006
|
|
|
He 20. 4802 :C 93
|
|
|
|
Guidance for industry and FDA [electronic resource] : current good manufacturing practice for combina
HE 20.4802:C 93
;
Axe Federal Documents Online:Available
|
ElectronicResource GovDoc
|
2004
|
|
Guidance for industry and FDA [electronic resource] : current good manufacturing practice for combina
Axe Federal Documents Online:Available
|
ElectronicResource GovDoc
|
2004
|
|
|
He 20. 4802 :D 8/ 4/Draft
|
|
|
|
Guidance for industry [electronic resource] : drug-induced liver injury, premarketing clinical evalua
HE 20.4802:D 8/4/DRAFT
;
Axe Federal Documents Online:Available
|
ElectronicResource GovDoc
|
2007
|
|
Guidance for industry [electronic resource] : drug-induced liver injury, premarketing clinical evalua
Axe Federal Documents Online:Available
|
ElectronicResource GovDoc
|
2007
|
|
|
He 20. 4802 :D 26
|
|
|
|
Guidance for industry [electronic resource] : year 2000 date change for computer systems and software
HE 20.4802:D 26
;
Axe Federal Documents Online:Available
|
ElectronicResource GovDoc
|
1998
|
|
Guidance for industry [electronic resource] : year 2000 date change for computer systems and software
Axe Federal Documents Online:Available
|
ElectronicResource GovDoc
|
1998
|
|
|
He 20. 4802 :D 49
|
|
|
|
Modifications to devices subject to premarket approval (PMA) [electronic resource] : the PMA suppleme
HE 20.4802:D 49
;
Axe Federal Documents Online:Available
|
ElectronicResource GovDoc
|
2008
|
|
Modifications to devices subject to premarket approval (PMA) [electronic resource] : the PMA suppleme
Axe Federal Documents Online:Available
|
ElectronicResource GovDoc
|
2008
|
|
|
He 20. 4802 :D 49/ 2
|
|
|
|
E2f development safety update report [electronic resource].
HE 20.4802:D 49/2
;
Axe Federal Documents Online:Available
|
ElectronicResource GovDoc
|
2008
|
|
E2f development safety update report [electronic resource].
Axe Federal Documents Online:Available
|
ElectronicResource GovDoc
|
2008
|
|
|
He 20. 4802 :D 49/ 3
|
|
|
|
Guidance for industry and FDA staff [electronic resource] : interactive review for medical device sub
HE 20.4802:D 49/3
;
Axe Federal Documents Online:Available
|
ElectronicResource GovDoc
|
2008
|
|
Guidance for industry and FDA staff [electronic resource] : interactive review for medical device sub
Axe Federal Documents Online:Available
|
ElectronicResource GovDoc
|
2008
|
|
|
He 20. 4802 :D 49/ 4
|
|
|
|
Guidance for industry [electronic resource] : considerations for developmental toxicity studies for p
HE 20.4802:D 49/4
;
Axe Federal Documents Online:Available
|
ElectronicResource GovDoc
|
2006
|
|
Guidance for industry [electronic resource] : considerations for developmental toxicity studies for p
Axe Federal Documents Online:Available
|
ElectronicResource GovDoc
|
2006
|
|
|
He 20. 4802 :D 63
|
|
|
|
Guidance for industry and staff [electronic resource] : resolution of disputes concerning payment or
HE 20.4802:D 63
;
Axe Federal Documents Online:Available
|
ElectronicResource GovDoc
|
2004
|
|
Guidance for industry and staff [electronic resource] : resolution of disputes concerning payment or
Axe Federal Documents Online:Available
|
ElectronicResource GovDoc
|
2004
|
|
|
He 20. 4802 :D 71
|
|
|
|
Guidance for industry [electronic resource] : adequate and appropriate donor screening for hepatitis
HE 20.4802:D 71
;
Axe Federal Documents Online:Available
|
ElectronicResource GovDoc
|
2007
|
|
Guidance for industry [electronic resource] : adequate and appropriate donor screening for hepatitis
Axe Federal Documents Online:Available
|
ElectronicResource GovDoc
|
2007
|
|
|
He 20. 4802 :D 71/ 2
|
|
|
|
Guidance for industry [electronic resource] : implementation of acceptable full-length donor history
HE 20.4802:D 71/2
;
Axe Federal Documents Online:Available
|
ElectronicResource GovDoc
|
2006
|
|
Guidance for industry [electronic resource] : implementation of acceptable full-length donor history
Axe Federal Documents Online:Available
|
ElectronicResource GovDoc
|
2006
|
|
|
He 20. 4802 :D 71/ 3
|
|
|
|
Guidance for industry [electronic resource] : amendment (donor deferral for transfusion in France sin
HE 20.4802:D 71/3
;
Axe Federal Documents Online:Available
|
ElectronicResource GovDoc
|
2006
|
|
Guidance for industry [electronic resource] : amendment (donor deferral for transfusion in France sin
Axe Federal Documents Online:Available
|
ElectronicResource GovDoc
|
2006
|
|
|
He 20. 4802 :D 71/ 4
|
|
|
|
Guidance for industry [electronic resource] : assessing donor suitability and blood and blood product
HE 20.4802:D 71/4
;
Axe Federal Documents Online:Available
|
ElectronicResource GovDoc
|
2005
|
|
Guidance for industry [electronic resource] : assessing donor suitability and blood and blood product
Axe Federal Documents Online:Available
|
ElectronicResource GovDoc
|
2005
|
|
|
He 20. 4802 :D 71/ 5
|
|
|
|
Guidance for industry [electronic resource] : revised recommendations for the assessment of donor sui
HE 20.4802:D 71/5
;
Axe Federal Documents Online:Available
|
ElectronicResource GovDoc
|
2003
|
|
Guidance for industry [electronic resource] : revised recommendations for the assessment of donor sui
Axe Federal Documents Online:Available
|
ElectronicResource GovDoc
|
2003
|
|
|
He 20. 4802 :D 71/ 6
|
|
|
|
Guidance for industry [electronic resource] : streamlining the donor interview process, recommendatio
HE 20.4802:D 71/6
;
Axe Federal Documents Online:Available
|
ElectronicResource GovDoc
|
2003
|
|
Guidance for industry [electronic resource] : streamlining the donor interview process, recommendatio
Axe Federal Documents Online:Available
|
ElectronicResource GovDoc
|
2003
|
|
|
He 20. 4802 :D 71/ 7
|
|
|
|
Guidance for industry [electronic resource] : revised recommendations for donor and product managemen
HE 20.4802:D 71/7
;
Axe Federal Documents Online:Available
|
ElectronicResource GovDoc
|
2003
|
|
Guidance for industry [electronic resource] : revised recommendations for donor and product managemen
Axe Federal Documents Online:Available
|
ElectronicResource GovDoc
|
2003
|
|
|
He 20. 4802 :D 71/ 8
|
|
|
|
Guidance for industry [electronic resource] : recommendations for deferral of donors and quarantine a
HE 20.4802:D 71/8
;
Axe Federal Documents Online:Available
|
ElectronicResource GovDoc
|
2002
|
|
Guidance for industry [electronic resource] : recommendations for deferral of donors and quarantine a
Axe Federal Documents Online:Available
|
ElectronicResource GovDoc
|
2002
|
|
|
He 20. 4802 :D 71/ 9
|
|
|
|
Guidance for industry [electronic resource] : recommendations for assessment of donor suitability and
HE 20.4802:D 71/9
;
Axe Federal Documents Online:Available
|
ElectronicResource GovDoc
|
2001
|
|
Guidance for industry [electronic resource] : recommendations for assessment of donor suitability and
Axe Federal Documents Online:Available
|
ElectronicResource GovDoc
|
2001
|
|
|
He 20. 4802 :D 71/ 10
|
|
|
|
Guidance for industry [electronic resource] : recommendations for donor questioning regarding possibl
HE 20.4802:D 71/10
;
Axe Federal Documents Online:Available
|
ElectronicResource GovDoc
|
2000
|
|
Guidance for industry [electronic resource] : recommendations for donor questioning regarding possibl
Axe Federal Documents Online:Available
|
ElectronicResource GovDoc
|
2000
|
|
|
He 20. 4802 :D 84/ 2
|
|
|
|
Guidance for industry [electronic resource] : submitting type V drug master files to the Center for B
HE 20.4802:D 84/2
;
Axe Federal Documents Online:Available
|
ElectronicResource GovDoc
|
2001
|
|
Guidance for industry [electronic resource] : submitting type V drug master files to the Center for B
Axe Federal Documents Online:Available
|
ElectronicResource GovDoc
|
2001
|
|
|
He 20. 4802 :D 84/ 3
|
|
|
|
A review of FDA's implementation of the Drug Export Amendments of 1986 [electronic resource].
HE 20.4802:D 84/3
;
Axe Federal Documents Online:Available
|
ElectronicResource GovDoc
|
1990
|
|
A review of FDA's implementation of the Drug Export Amendments of 1986 [electronic resource].
Axe Federal Documents Online:Available
|
ElectronicResource GovDoc
|
1990
|
|
|
He 20. 4802 :Ef 3
|
|
|
|
Guidance for industry [electronic resource] : integrated summary of effectiveness.
HE 20.4802:EF 3
;
Axe Federal Documents Online:Available
|
ElectronicResource GovDoc
|
2008
|
|
Guidance for industry [electronic resource] : integrated summary of effectiveness.
Axe Federal Documents Online:Available
|
ElectronicResource GovDoc
|
2008
|
|
|
He 20. 4802 :Ef 4
|
|
|
|
Guidance for industry [electronic resource] : efficacy studies to support marketing of fibrin sealant
HE 20.4802:EF 4
;
Axe Federal Documents Online:Available
|
ElectronicResource GovDoc
|
1999
|
|
Guidance for industry [electronic resource] : efficacy studies to support marketing of fibrin sealant
Axe Federal Documents Online:Available
|
ElectronicResource GovDoc
|
1999
|
|
|
He 20. 4802 :El 4
|
|
|
|
Guidance for industry [electronic resource] : eligibility determination for donors of human cells, ti
HE 20.4802:EL 4
;
Axe Federal Documents Online:Available
|
ElectronicResource GovDoc
|
2007
|
|
Guidance for industry [electronic resource] : eligibility determination for donors of human cells, ti
Axe Federal Documents Online:Available
|
ElectronicResource GovDoc
|
2007
|
|
|
He 20. 4802 :F 26
|
|
|
|
Guidance for industry [electronic resource] : notifying FDA of fatalities related to blood collection
HE 20.4802:F 26
;
Axe Federal Documents Online:Available
|
ElectronicResource GovDoc
|
2003
|
|
Guidance for industry [electronic resource] : notifying FDA of fatalities related to blood collection
Axe Federal Documents Online:Available
|
ElectronicResource GovDoc
|
2003
|
|
|
He 20. 4802 :F 73
|
|
|
|
Guidance for industry [electronic resource] : FDA export certificates.
HE 20.4802:F 73
;
Axe Federal Documents Online:Available
|
ElectronicResource GovDoc
|
2005
|
|
Guidance for industry [electronic resource] : FDA export certificates.
Axe Federal Documents Online:Available
|
ElectronicResource GovDoc
|
2005
|
|
|
He 20. 4802 :F 73/ 2
|
|
|
|
FDA and industry actions on premarket notification (510(k)) submissions, effect on FDA review clock a
HE 20.4802:F 73/2
;
Axe Federal Documents Online:Available
|
ElectronicResource GovDoc
|
2004
|
|
FDA and industry actions on premarket notification (510(k)) submissions, effect on FDA review clock a
Axe Federal Documents Online:Available
|
ElectronicResource GovDoc
|
2004
|
|
|
He 20. 4802 :G 28
|
|
|
|
Forum 1996 [electronic resource] : gene therapy : development and evaluation of phase I products : ve
HE 20.4802:G 28
;
Axe Federal Documents Online:Available
|
ElectronicResource GovDoc
|
1996
|
|
Forum 1996 [electronic resource] : gene therapy : development and evaluation of phase I products : ve
Axe Federal Documents Online:Available
|
ElectronicResource GovDoc
|
1996
|
|
|
He 20. 4802 :G 28/ 2
|
|
|
|
Guidance for industry [electronic resource] : E15 definitions for genomic biomarkers, pharmacogenomic
HE 20.4802:G 28/2
;
Axe Federal Documents Online:Available
|
ElectronicResource GovDoc
|
2008
|
|
Guidance for industry [electronic resource] : E15 definitions for genomic biomarkers, pharmacogenomic
Axe Federal Documents Online:Available
|
ElectronicResource GovDoc
|
2008
|
|
|
He 20. 4802 :G 28/ 3
|
|
|
|
Guidance for industry [electronic resource] : gene therapy clinical trials, observing subjects for de
HE 20.4802:G 28/3
;
Axe Federal Documents Online:Available
|
ElectronicResource GovDoc
|
2006
|
|
Guidance for industry [electronic resource] : gene therapy clinical trials, observing subjects for de
Axe Federal Documents Online:Available
|
ElectronicResource GovDoc
|
2006
|
|
|
He 20. 4802 :H 41
|
|
|
|
Guidance for industry [electronic resource] : "lookback" for hepatitis c virus (HCV) : product quaran
HE 20.4802:H 41
;
Axe Federal Documents Online:Available
|
ElectronicResource GovDoc
|
2007
|
|
Guidance for industry [electronic resource] : "lookback" for hepatitis c virus (HCV) : product quaran
Axe Federal Documents Online:Available
|
ElectronicResource GovDoc
|
2007
|
|
|
He 20. 4802 :H 88
|
|
|
|
Draft guidance for HDE holders, institutional review boards (IRBs), clinical investigators, and FDA s
HE 20.4802:H 88
;
Axe Federal Documents Online:Available
|
ElectronicResource GovDoc
|
2008
|
|
Draft guidance for HDE holders, institutional review boards (IRBs), clinical investigators, and FDA s
Axe Federal Documents Online:Available
|
ElectronicResource GovDoc
|
2008
|
|
|
He 20. 4802 :H 88/ 2
|
|
|
|
Guidance for industry [electronic resource] : guidance for human somatic cell therapy and gene therap
HE 20.4802:H 88/2
;
Axe Federal Documents Online:Available
|
ElectronicResource GovDoc
|
1998
|
|
Guidance for industry [electronic resource] : guidance for human somatic cell therapy and gene therap
Axe Federal Documents Online:Available
|
ElectronicResource GovDoc
|
1998
|
 Add Marked to Bag
Add All On Page
|
