Chapter 5: Pharmaceutical Labeling in the US
52 Regulatory Affairs Professionals Society (RAPS)
44. Food and Drug Administration. Pediatric Information
Incorporated into Human Prescription Drug and
Biological Products Labeling Good Review Practice
[guidance]. Current as of 15 May 2020. Accessed
9 October 2023. https://www.fda.gov/downloads/
Drugs/GuidanceComplianceRegulatoryInformation/
Guidances/UCM341394.pdf
45. Food and Drug Administration. Geriatric Information
in Human Prescription Drug and Biological Product
Labeling [draft guidance]. Dated September 2020.
Accessed 31 August 2023. https://www.fda.gov/
media/142162/download
46. Food and Drug Administration. Immunogenicity
Information in Human Prescription Therapeutic
Protein and Select Drug Product Labeling – Content
and Format [draft guidance]. Dated February
2022. Accessed 19 July 2023. https://www.fda.gov/
media/155871/download
47. Food and Drug Administration. Prescribing
Information Resources. Current as of 18 September
2023. Accessed 19 July 2023. https://www.fda.gov/
drugs/fdas-labeling-resources-human-prescrip-
tion-drugs/prescribing-information-resources
48. Food and Drug Administration. Content and Format of
Labeling for Human Prescription Drug and Biological
Products Requirements for Pregnancy and Lactation
Labeling, Final Rule, 79 Fed. Reg. 72064. Dated 4
December 2014. Accessed 31 August 2023. https://
www.govinfo.gov/content/pkg/FR-2014-12-04/
pdf/2014-28241.pdf
49. Food and Drug Administration. Pregnancy and
Lactation Labeling (Drugs) Final Rule. Current as of 5
March 2023. Accessed 6 November 2023. https://www.
fda.gov/drugs/labeling-information-drug-products/
pregnancy-and-lactation-labeling-drugs-final-rule
50. Food and Drug Administration. Drug Abuse
and Dependence Section of Labeling for Human
Prescription Drug and Biological Products – Content
and Format [guidance]. Current as of 25 October 2019.
Accessed 31 August 2023. https://www.fda.gov/regu-
latory-information/search-fda-guidance-documents/
drug-abuse-and-dependence-section-labeling-hu-
man-prescription-drug-and-biological-products-con-
tent
51. 21 CFR Part 314, Applications for FDA approval to
market a new drug. Up to date as of 19 October 2023.
Accessed 31 August 2023. https://www.ecfr.gov/cur-
rent/title-21/chapter-I/subchapter-D/part-314
52. 21 CFR Part 601.2, Applications for biologics licenses
procedures for filing. Up to date as of 19 October
2023. Accessed 31 August 2023. https://www.ecfr.gov/
cgi-bin/text-idx?SID=49fb372f88fd0405679c786a8ff-
643b2&mc=true&node=se21.7.601_12&rgn=div8
53. International Council for Harmonisation. CTD –
M4: The Common Technical Document. Not dated.
Accessed 31 August 2023. https://www.ich.org/page/
ctd
54. 21 CFR Part 314.50, Content and format of an
NDA. Up to date as of 19 October 2023. Accessed 6
November 2023. https://www.ecfr.gov/cgi-bin/text-idx-
?SID=4205e51a9069c42353cd311d2f294920&mc=true
&node=se21.5.314_150&rgn=div8
55. Food and Drug Administration. Providing Regulatory
Submissions in Electronic Format – Content of
Labeling. Current as of 24 August 2018. Accessed 6
November 2023. https://www.fda.gov/downloads/
Drugs/GuidanceComplianceRegulatoryInformation/
Guidances/UCM072331.pdf
56. Food and Drug Administration. Labeling Policy Team.
Current as of 21 June 2022. Accessed 6 November
2023. https://www.fda.gov/AboutFDA/CentersOffices/
OfficeofMedicalProductsandTobacco/CDER/
ucm443026.htm
57. Food and Drug Administration. Expedited Programs
for Serious Conditions – Drugs and Biologics
[guidance – procedural]. Dated May 2014. Accessed 6
November 2023. https://www.fda.gov/media/86377/
download
58. Food and Drug Administration. Labeling for Human
Prescription Drug and Biological Products Approved
Under the Accelerated Approval Regulatory Pathway
[guidance]. Dated January 2019. Accessed 6 November
2023. https://www.fda.gov/media/119755/download
59. Kircik L, et al. United States Food and Drug
Administration product label changes. J Clin Aesthet
Dermatol. 2016 9(1):39-48. Verified 6 November 2023.
60. 21 CFR Part 314.70, Supplements and other changes to
an approved NDA. Up to date as of 19 October 2023.
Accessed 31 August 2023. https://www.ecfr.gov/cgi-
bin/text-idx?SID=45b4b42cade0186a1375c672622093
82&mc=true&node=se21.5.314_170&rgn=div8
61. 21 CFR Part 601.12, Changes to an approved appli-
cation. Up to date as of 19 October 2023. Accessed 31
August 2023. https://www.ecfr.gov/cgi-bin/text-idx-
?SID=68c65905a80147a99ca0689c0112b1ab&mc=true
&node=se21.7.601_112&rgn=div8
62. Food and Drug Administration. Changes to an
Approved NDA or ANDA [guidance]. Dated April
2004. Accessed 24 August 2023. https://www.fda.gov/
files/drugs/published/Changes-to-an-Approved-NDA-
or-ANDA.pdf
63. 21 CFR Part 601.12(b), Changes requiring supplement
submission and approval prior to distribution of the
product made using the change (major changes). Up
to date as of 19 October 2023. Accessed 31 August
2023. https://www.ecfr.gov/cgi-bin/text-idx?SID=-
68c65905a80147a99ca0689c0112b1ab&mc=true&node
=se21.7.601_112&rgn=div8
64. 21 CFR Part 601.12(f)(1), Labeling changes requiring
supplement submission. Up to date as of 19 October
2023. Accessed 31 August 2023. https://www.ecfr.gov/
cgi-bin/text-idx?SID=68c65905a80147a99ca0689c-
0112b1ab&mc=true&node=se21.7.601_112&rgn=div8
52 Regulatory Affairs Professionals Society (RAPS)
44. Food and Drug Administration. Pediatric Information
Incorporated into Human Prescription Drug and
Biological Products Labeling Good Review Practice
[guidance]. Current as of 15 May 2020. Accessed
9 October 2023. https://www.fda.gov/downloads/
Drugs/GuidanceComplianceRegulatoryInformation/
Guidances/UCM341394.pdf
45. Food and Drug Administration. Geriatric Information
in Human Prescription Drug and Biological Product
Labeling [draft guidance]. Dated September 2020.
Accessed 31 August 2023. https://www.fda.gov/
media/142162/download
46. Food and Drug Administration. Immunogenicity
Information in Human Prescription Therapeutic
Protein and Select Drug Product Labeling – Content
and Format [draft guidance]. Dated February
2022. Accessed 19 July 2023. https://www.fda.gov/
media/155871/download
47. Food and Drug Administration. Prescribing
Information Resources. Current as of 18 September
2023. Accessed 19 July 2023. https://www.fda.gov/
drugs/fdas-labeling-resources-human-prescrip-
tion-drugs/prescribing-information-resources
48. Food and Drug Administration. Content and Format of
Labeling for Human Prescription Drug and Biological
Products Requirements for Pregnancy and Lactation
Labeling, Final Rule, 79 Fed. Reg. 72064. Dated 4
December 2014. Accessed 31 August 2023. https://
www.govinfo.gov/content/pkg/FR-2014-12-04/
pdf/2014-28241.pdf
49. Food and Drug Administration. Pregnancy and
Lactation Labeling (Drugs) Final Rule. Current as of 5
March 2023. Accessed 6 November 2023. https://www.
fda.gov/drugs/labeling-information-drug-products/
pregnancy-and-lactation-labeling-drugs-final-rule
50. Food and Drug Administration. Drug Abuse
and Dependence Section of Labeling for Human
Prescription Drug and Biological Products – Content
and Format [guidance]. Current as of 25 October 2019.
Accessed 31 August 2023. https://www.fda.gov/regu-
latory-information/search-fda-guidance-documents/
drug-abuse-and-dependence-section-labeling-hu-
man-prescription-drug-and-biological-products-con-
tent
51. 21 CFR Part 314, Applications for FDA approval to
market a new drug. Up to date as of 19 October 2023.
Accessed 31 August 2023. https://www.ecfr.gov/cur-
rent/title-21/chapter-I/subchapter-D/part-314
52. 21 CFR Part 601.2, Applications for biologics licenses
procedures for filing. Up to date as of 19 October
2023. Accessed 31 August 2023. https://www.ecfr.gov/
cgi-bin/text-idx?SID=49fb372f88fd0405679c786a8ff-
643b2&mc=true&node=se21.7.601_12&rgn=div8
53. International Council for Harmonisation. CTD –
M4: The Common Technical Document. Not dated.
Accessed 31 August 2023. https://www.ich.org/page/
ctd
54. 21 CFR Part 314.50, Content and format of an
NDA. Up to date as of 19 October 2023. Accessed 6
November 2023. https://www.ecfr.gov/cgi-bin/text-idx-
?SID=4205e51a9069c42353cd311d2f294920&mc=true
&node=se21.5.314_150&rgn=div8
55. Food and Drug Administration. Providing Regulatory
Submissions in Electronic Format – Content of
Labeling. Current as of 24 August 2018. Accessed 6
November 2023. https://www.fda.gov/downloads/
Drugs/GuidanceComplianceRegulatoryInformation/
Guidances/UCM072331.pdf
56. Food and Drug Administration. Labeling Policy Team.
Current as of 21 June 2022. Accessed 6 November
2023. https://www.fda.gov/AboutFDA/CentersOffices/
OfficeofMedicalProductsandTobacco/CDER/
ucm443026.htm
57. Food and Drug Administration. Expedited Programs
for Serious Conditions – Drugs and Biologics
[guidance – procedural]. Dated May 2014. Accessed 6
November 2023. https://www.fda.gov/media/86377/
download
58. Food and Drug Administration. Labeling for Human
Prescription Drug and Biological Products Approved
Under the Accelerated Approval Regulatory Pathway
[guidance]. Dated January 2019. Accessed 6 November
2023. https://www.fda.gov/media/119755/download
59. Kircik L, et al. United States Food and Drug
Administration product label changes. J Clin Aesthet
Dermatol. 2016 9(1):39-48. Verified 6 November 2023.
60. 21 CFR Part 314.70, Supplements and other changes to
an approved NDA. Up to date as of 19 October 2023.
Accessed 31 August 2023. https://www.ecfr.gov/cgi-
bin/text-idx?SID=45b4b42cade0186a1375c672622093
82&mc=true&node=se21.5.314_170&rgn=div8
61. 21 CFR Part 601.12, Changes to an approved appli-
cation. Up to date as of 19 October 2023. Accessed 31
August 2023. https://www.ecfr.gov/cgi-bin/text-idx-
?SID=68c65905a80147a99ca0689c0112b1ab&mc=true
&node=se21.7.601_112&rgn=div8
62. Food and Drug Administration. Changes to an
Approved NDA or ANDA [guidance]. Dated April
2004. Accessed 24 August 2023. https://www.fda.gov/
files/drugs/published/Changes-to-an-Approved-NDA-
or-ANDA.pdf
63. 21 CFR Part 601.12(b), Changes requiring supplement
submission and approval prior to distribution of the
product made using the change (major changes). Up
to date as of 19 October 2023. Accessed 31 August
2023. https://www.ecfr.gov/cgi-bin/text-idx?SID=-
68c65905a80147a99ca0689c0112b1ab&mc=true&node
=se21.7.601_112&rgn=div8
64. 21 CFR Part 601.12(f)(1), Labeling changes requiring
supplement submission. Up to date as of 19 October
2023. Accessed 31 August 2023. https://www.ecfr.gov/
cgi-bin/text-idx?SID=68c65905a80147a99ca0689c-
0112b1ab&mc=true&node=se21.7.601_112&rgn=div8
