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2019-07-02
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Instructions for Use-Patient Labeling for Human Prescription Drug and Biological Products and Drug-Device and Biologic-Device Combination Products-Content and Format; Draft Guidance for Industry; Availability
Notices
D09002ee1bdb70c59
D09002ee1bdb70ccb
United States
Department of Health and Human Services
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org
United States Government Agency or Subagency
United States
Food and Drug Administration
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org
United States Government Agency or Subagency
The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled ``Instructions for Use--Patient Labeling for Human Prescription Drug and Biological Products and Drug-Device and Biologic-Device Combination Products--Content and Format.'' This draft guidance provides recommendations for developing the content and format of an Instructions for Use (IFU) document for human prescription drugs and biological products and drug-device or biologic-device combination products submitted under a new drug application (NDA) or a biologics license application (BLA). The IFU is developed by applicants for patients who use drug products that have complicated or detailed patient-use instructions. The recommendations in this draft guidance are intended to help develop consistent content and format across IFUs and to help ensure that patients receive clear, concise information that is easily understood for the safe and effective use of prescription drug products.
84 FR 31598
https://www.govinfo.gov/app/details/FR-2019-07-02/2019-14060
2019-14060
fr02jy19-62
4164-01-P
Docket No. FDA-2019-D-1615
https://www.govinfo.gov/app/details/FR-2019-07-02/2019-14060
https://www.govinfo.gov/content/pkg/FR-2019-07-02/html/2019-14060.htm
https://www.govinfo.gov/content/pkg/FR-2019-07-02/pdf/2019-14060.pdf
3 p.
31598
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84 FR 31598
Instructions for Use-Patient Labeling for Human Prescription Drug and Biological Products and Drug-Device and Biologic-Device Combination Products-Content and Format; Draft Guidance for Industry; Availability; Federal Register Vol. 84, Issue
NOTICE
2019-14060
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
2019-09-03
Docket No. FDA-2019-D-1615
4164-01-P
2019-14060
Notice of availability.
The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled ``Instructions for Use--Patient Labeling for Human Prescription Drug and Biological Products and Drug-Device and Biologic-Device Combination Products--Content and Format.'' This draft guidance provides recommendations for developing the content and format of an Instructions for Use (IFU) document for human prescription drugs and biological products and drug-device or biologic-device combination products submitted under a new drug application (NDA) or a biologics license application (BLA). The IFU is developed by applicants for patients who use drug products that have complicated or detailed patient-use instructions. The recommendations in this draft guidance are intended to help develop consistent content and format across IFUs and to help ensure that patients receive clear, concise information that is easily understood for the safe and effective use of prescription drug products.
Submit either electronic or written comments on the draft guidance by September 3, 2019 to ensure that the Agency considers your comment on this draft guidance before it begins work on the final version of the guidance.
Chris Wheeler, Center for Drug Evaluation and Research, 10903 New Hampshire Ave., Bldg. 51, Rm. 3330, Silver Spring, MD 20993, 301-796-0151; or Stephen Ripley, Center for Biologics Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 71, Rm. 7301, Silver Spring, MD 20993, 240- 402-7911.
Guidance:
Instructions for UsePatient Labeling for Human Prescription Drug and Biological Products and Drug-Device and Biologic-Device Combination ProductsContent and Format
,
https://www.fda.gov/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/Guidances/default.htm
https://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htm
https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/default.htm
https://www.gpo.gov/fdsys/pkg/FR-2015-09-18/pdf/2015-23389.pdf
https://www.regulations.gov
Federal Register
Vol. 84, no. 127
Office of the Federal Register, National Archives and Records Administration
2019-07-02
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236 p.
Table of Contents:
AE 2.7:
GS 4.107:
AE 2.106:
KF70.A2
https://www.govinfo.gov/app/details/FR-2019-07-02
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0042-1219
0364-1406
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000582072
f:fr02jy19
https://www.govinfo.gov/app/details/FR-2019-07-02
https://www.govinfo.gov/content/pkg/FR-2019-07-02/pdf/FR-2019-07-02.pdf
https://www.govinfo.gov/content/pkg/FR-2019-07-02/xml/FR-2019-07-02.xml
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