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2018-02-23
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Request for Quality Metrics; Notice of Draft Guidance Availability and Public Meeting; Request for Comments
Notices
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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), Center for Drug Evaluation and Research (CDER) and Center for Biologics Evaluation and Research (CBER), is announcing the availability of a draft guidance for industry entitled ``Request for Quality Metrics'' and a public meeting regarding the Agency's plans associated with a quality metrics reporting program. The draft guidance and public meeting are intended to gain stakeholders' perspectives on various aspects of the development and planned implementation of a quality metrics program launched under the authority of the Food, Drug, and Cosmetic Act (the FD&C Act). The guidance includes an explanation of how FDA intends to use quality metrics data to further develop the FDA's risk-based inspection scheduling, to identify situations in which there may be a risk for drug supply disruption, to improve the efficiency and effectiveness of establishment inspections, and to improve FDA's evaluation of drug manufacturing and control operations. FDA expects that the initial use of the metrics will be to consider a decreased surveillance inspection frequency for certain establishments. For example, establishments that have highly controlled manufacturing processes have the potential to be inspected less often (as a lower priority for inspection) than similar establishments that demonstrate uncontrolled processes (as a higher priority for inspection). In addition, FDA intends to consider whether these metrics may provide a basis for FDA to use improved risk-based principles to determine the appropriate reporting category for postapproval manufacturing changes. FDA intends to consider the input from this public meeting as we finalize this guidance and the planned implementation of this program, including FDA's initial set of requests for quality metrics data.
80 FR 44973
https://www.govinfo.gov/app/details/FR-2015-07-28/2015-18448
2015-18448
fr28jy15-77
4164-01-P
Docket No. FDA-2014-D-2537
https://www.govinfo.gov/app/details/FR-2015-07-28/2015-18448
https://www.govinfo.gov/content/pkg/FR-2015-07-28/html/2015-18448.htm
https://www.govinfo.gov/content/pkg/FR-2015-07-28/pdf/2015-18448.pdf
5 p.
44973
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80 FR 44973
Request for Quality Metrics; Notice of Draft Guidance Availability and Public Meeting; Request for Comments; Federal Register Vol. 80, Issue
NOTICE
2015-18448
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
2015-08-24
Docket No. FDA-2014-D-2537
4164-01-P
2015-18448
Notice of meeting; notice of draft guidance availability, request for comments.
The Food and Drug Administration (FDA), Center for Drug Evaluation and Research (CDER) and Center for Biologics Evaluation and Research (CBER), is announcing the availability of a draft guidance for industry entitled ``Request for Quality Metrics'' and a public meeting regarding the Agency's plans associated with a quality metrics reporting program. The draft guidance and public meeting are intended to gain stakeholders' perspectives on various aspects of the development and planned implementation of a quality metrics program launched under the authority of the Food, Drug, and Cosmetic Act (the FD&C Act). The guidance includes an explanation of how FDA intends to use quality metrics data to further develop the FDA's risk-based inspection scheduling, to identify situations in which there may be a risk for drug supply disruption, to improve the efficiency and effectiveness of establishment inspections, and to improve FDA's evaluation of drug manufacturing and control operations. FDA expects that the initial use of the metrics will be to consider a decreased surveillance inspection frequency for certain establishments. For example, establishments that have highly controlled manufacturing processes have the potential to be inspected less often (as a lower priority for inspection) than similar establishments that demonstrate uncontrolled processes (as a higher priority for inspection). In addition, FDA intends to consider whether these metrics may provide a basis for FDA to use improved risk-based principles to determine the appropriate reporting category for postapproval manufacturing changes. FDA intends to consider the input from this public meeting as we finalize this guidance and the planned implementation of this program, including FDA's initial set of requests for quality metrics data.
The meeting will be held on August 24, 2015, from 8:30 a.m. to 5 p.m. The meeting may be extended or end early depending on the level of public participation. Register to attend or present at the meeting by August 7, 2015, (see section V.C. for information on how to register or make a presentation at the meeting). If you cannot attend in person, information about how you can access a live Web cast will be located at http://www.fda.gov/Drugs/NewsEvents/ucm451529.htm.
Althea Cuff, Food and Drug Administration, 10903 New Hampshire Ave., Silver Spring, MD 20993-0002, 301-796-4061, email: Althea.Cuff@fda.hhs.gov.
Meetings:
Request for Quality Metrics
,
Althea.Cuff@fda.hhs.gov
http://www.fda.gov/AboutFDA/WorkingatFDA/BuildingsandFacilities/WhiteOakCampusInformation/ucm241740.htm
http://www.fda.gov/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/default.htm
http://www.fda.gov/downloads/AboutFDA/CentersOffices/OfficeofMedicalProductsandTobacco/CDER/UCM442666.pdf
http://www.fda.gov/downloads/drugs/drugsafety/drugshortages/ucm372566.pdf
http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htm
http://www.fda.gov/Drugs/NewsEvents/ucm451529.htm
http://www.regulations.gov
https://collaboration.fda.gov/qmpm2015/
https://qualitymetrics-public-meeting.eventbrite.com
Federal Register
Vol. 80, no. 144
Office of the Federal Register, National Archives and Records Administration
2015-07-28
continuing
daily
deposited
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232 p.
Table of Contents:
AE 2.7:
GS 4.107:
AE 2.106:
KF70.A2
https://www.govinfo.gov/app/details/FR-2015-07-28
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https://www.govinfo.gov/app/details/FR-2015-07-28
https://www.govinfo.gov/content/pkg/FR-2015-07-28/pdf/FR-2015-07-28.pdf
https://www.govinfo.gov/content/pkg/FR-2015-07-28/xml/FR-2015-07-28.xml
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