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2019-02-15
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Established Conditions; Pilot Program
Notices
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D09002ee1bdb7b502
United States
Department of Health and Human Services
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United States Government Agency or Subagency
United States
Food and Drug Administration
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United States Government Agency or Subagency
The Food and Drug Administration (FDA or Agency), Center for Drug Evaluation and Research (CDER) is announcing the opportunity for a limited number of applicants to participate in an Established Conditions Pilot Program, to propose explicit established conditions (ECs) as part of an original new drug application (NDA), abbreviated new drug application (ANDA), biologics license application (BLA), or as a prior approval supplement (PAS) to any of these. The concept of ECs was first described in the FDA draft guidance for industry entitled ``Established Conditions: Reportable CMC Changes for Approved Drug and Biologic Products'', issued May 2015 and has been further discussed in the International Council for Harmonisation (ICH) draft guidance for industry entitled ``Q12 Technical and Regulatory Considerations for Pharmaceutical Product Lifecycle Management; International Council for Harmonisation'', issued May 30, 2018. FDA is implementing this pilot program to gain experience receiving, assessing, and engaging with applicants regarding proposed ECs (i.e., explicit ECs).
84 FR 4478
https://www.govinfo.gov/app/details/FR-2019-02-15/2019-02364
2019-02364
fr15fe19-87
4164-01-P
Docket No. FDA-2018-N-4414
https://www.govinfo.gov/app/details/FR-2019-02-15/2019-02364
https://www.govinfo.gov/content/pkg/FR-2019-02-15/html/2019-02364.htm
https://www.govinfo.gov/content/pkg/FR-2019-02-15/pdf/2019-02364.pdf
2 p.
4478
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84 FR 4478
Established Conditions; Pilot Program; Federal Register Vol. 84, Issue
NOTICE
2019-02364
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
2019-05-30
Docket No. FDA-2018-N-4414
4164-01-P
2019-02364
Notice.
The Food and Drug Administration (FDA or Agency), Center for Drug Evaluation and Research (CDER) is announcing the opportunity for a limited number of applicants to participate in an Established Conditions Pilot Program, to propose explicit established conditions (ECs) as part of an original new drug application (NDA), abbreviated new drug application (ANDA), biologics license application (BLA), or as a prior approval supplement (PAS) to any of these. The concept of ECs was first described in the FDA draft guidance for industry entitled ``Established Conditions: Reportable CMC Changes for Approved Drug and Biologic Products'', issued May 2015 and has been further discussed in the International Council for Harmonisation (ICH) draft guidance for industry entitled ``Q12 Technical and Regulatory Considerations for Pharmaceutical Product Lifecycle Management; International Council for Harmonisation'', issued May 30, 2018. FDA is implementing this pilot program to gain experience receiving, assessing, and engaging with applicants regarding proposed ECs (i.e., explicit ECs).
FDA will accept nine requests submitted before May 30, 2019 from applicants intending to submit NDAs, ANDAs, or BLAs, either original applications or prior approval supplements, with proposed ECs.
Ashley Boam, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave. Silver Spring, MD 20993, 301-796-6341, CDER-OPQ- Inquiries@fda.hhs.gov.
Established Conditions; Pilot Program
,
CDER-OPQ-Inquiries@fda.hhs.gov
https://www.fda.gov/downloads/drugs/guidancecomplianceregulatoryinformation/guidances/ucm448638.pdf
https://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM583436.pdf
https://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM590547.pdf
https://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM609205.pdf
https://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM609662.pdf
https://www.regulations.gov
Federal Register
Vol. 84, no. 32
Office of the Federal Register, National Archives and Records Administration
2019-02-15
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380 p.
Table of Contents:
AE 2.7:
GS 4.107:
AE 2.106:
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https://www.govinfo.gov/app/details/FR-2019-02-15
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