United States Government Publishing Office
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United States
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FR
Regulatory Information
2017_register
executive
2018-02-01
article
Pediatric Postmarketing Pharmacovigilance and Drug Utilization Reviews; Establishment of a Public Docket; Request for Comments
Notices
D09002ee1bdbf2f4a
D09002ee1bdbf2fea
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) is establishing a public docket to collect comments related to the pediatric postmarketing pharmacovigilance and drug utilization reviews of products posted between September 17, 2016, and February 24, 2017, on the FDA Web site, but will not be presented at the March 6-7, 2017, Pediatric Advisory Committee (PAC) meeting. These reviews are intended to be available for review and comment by members of the PAC, interested parties (such as academic researchers, regulated industries, consortia, and patient groups), and the general public.
82 FR 11227
https://www.govinfo.gov/app/details/FR-2017-02-21/2017-03365
2017-03365
fr21fe17-69
4164-01-P
Docket No. FDA-2017-N-0595
https://www.govinfo.gov/app/details/FR-2017-02-21/2017-03365
https://www.govinfo.gov/content/pkg/FR-2017-02-21/html/2017-03365.htm
https://www.govinfo.gov/content/pkg/FR-2017-02-21/pdf/2017-03365.pdf
2 p.
11227
11228
82 FR 11227
Pediatric Postmarketing Pharmacovigilance and Drug Utilization Reviews; Establishment of a Public Docket; Request for Comments; Federal Register Vol. 82, Issue
NOTICE
2017-03365
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
2017-03-10
Docket No. FDA-2017-N-0595
4164-01-P
2017-03365
Notice; request for comments.
The Food and Drug Administration (FDA or Agency) is establishing a public docket to collect comments related to the pediatric postmarketing pharmacovigilance and drug utilization reviews of products posted between September 17, 2016, and February 24, 2017, on the FDA Web site, but will not be presented at the March 6-7, 2017, Pediatric Advisory Committee (PAC) meeting. These reviews are intended to be available for review and comment by members of the PAC, interested parties (such as academic researchers, regulated industries, consortia, and patient groups), and the general public.
Submit either electronic or written comments by March 10, 2017. The docket will open on February 27, 2017, and remain open until March 10, 2017.
Kenneth Quinto, Office of the Commissioner, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 32, Rm. 5145, Silver Spring, MD 20993, 240-402-2221, email: kenneth.quinto@fda.hhs.gov.
Pediatric Postmarketing Pharmacovigilance and Drug Utilization Reviews
,
kenneth.quinto@fda.hhs.gov
http://www.fda.gov/AdvisoryCommittees/CommitteesMeetingMaterials/PediatricAdvisoryCommittee/ucm510701.htm
http://www.fda.gov/regulatoryinformation/dockets/default.htm
http://www.regulations.gov
https://www.regulations.gov
Federal Register
Vol. 82, no. 33
Office of the Federal Register, National Archives and Records Administration
2017-02-21
continuing
daily
deposited
born digital
176 p.
Table of Contents:
AE 2.7:
GS 4.107:
AE 2.106:
KF70.A2
https://www.govinfo.gov/app/details/FR-2017-02-21
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0042-1219
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https://www.govinfo.gov/app/details/FR-2017-02-21
https://www.govinfo.gov/content/pkg/FR-2017-02-21/pdf/FR-2017-02-21.pdf
https://www.govinfo.gov/content/pkg/FR-2017-02-21/xml/FR-2017-02-21.xml
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FR-2017-02-21
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FR-2017-02-21
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