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2010-09-23
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Guidance for Industry on Nonclinical Studies for the Safety Evaluation of Pharmaceutical Excipients; Availability
Notices
D09002ee1bde3b1d0
D09002ee1bde3b258
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) is announcing the availability of a guidance for industry entitled ``Nonclinical Studies for the Safety Evaluation of Pharmaceutical Excipients.'' This document is intended to provide guidance on the types of toxicity information that FDA recommends be provided to the agency to support the use of new excipients in drug products. Previously, such information was not available to drug sponsors in a written document. This information should allow drug sponsors to determine if a potential new excipient is safe to use in drug products.
70 FR 28946
https://www.govinfo.gov/app/details/FR-2005-05-19/05-9957
05-9957
fr19my05-75
4160-01-S
Docket No. 2002D-0389
https://www.govinfo.gov/app/details/FR-2005-05-19/05-9957
https://www.govinfo.gov/content/pkg/FR-2005-05-19/html/05-9957.htm
https://www.govinfo.gov/content/pkg/FR-2005-05-19/pdf/05-9957.pdf
2 p.
28946
28947
70 FR 28946
Guidance for Industry on Nonclinical Studies for the Safety Evaluation of Pharmaceutical Excipients; Availability; Federal Register Vol. 70, Issue
NOTICE
05-9957
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
Docket No. 2002D-0389
4160-01-S
05-9957
Notice.
The Food and Drug Administration (FDA) is announcing the availability of a guidance for industry entitled ``Nonclinical Studies for the Safety Evaluation of Pharmaceutical Excipients.'' This document is intended to provide guidance on the types of toxicity information that FDA recommends be provided to the agency to support the use of new excipients in drug products. Previously, such information was not available to drug sponsors in a written document. This information should allow drug sponsors to determine if a potential new excipient is safe to use in drug products.
Submit written or electronic comments on agency guidances at any time.
For the Center for Drug Evaluation and Research: Robert E. Osterberg, Center for Drug Evaluation and Research (HFD-520), Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857, 301-827- 2120, or
Reports and guidance documents; availability, etc.:
Nonclinical Studies for Safety Evaluation of Pharmaceutical Excipients,
http://www.fda.gov/cber/guidelines.htm
http://www.fda.gov/cder/guidance/index.htm
http://www.fda.gov/dockets/ecomments
http://www.fda.gov/ohrms/dockets/default.htm
Federal Register
Vol. 70, no. 96
Office of the Federal Register, National Archives and Records Administration
2005-05-19
continuing
daily
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426 p.
Table of Contents:
AE 2.7:
GS 4.107:
AE 2.106:
KF70.A2
https://www.govinfo.gov/app/details/FR-2005-05-19
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0097-6326
0042-1219
0364-1406
769-004-00000-9
000582072
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https://www.govinfo.gov/app/details/FR-2005-05-19
https://www.govinfo.gov/content/pkg/FR-2005-05-19/pdf/FR-2005-05-19.pdf
https://www.govinfo.gov/content/pkg/FR-2005-05-19/xml/FR-2005-05-19.xml
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