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Draft Guidance for Industry on Bioequivalence Recommendation for Nitroglycerin Metered Spray/Sublingual Products and Metered Aerosol/Sublingual Products; Availability
Notices
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United States
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Food and Drug Administration
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The Food and Drug Administration (FDA) is announcing the availability of two draft guidances for industry entitled ``Bioequivalence Recommendations for Nitroglycerin,'' one for nitroglycerin metered spray/sublingual products and one for nitroglycerin metered aerosol/sublingual products. The recommendations provide specific guidance on the design of bioequivalence (BE) studies to support abbreviated new drug applications (ANDAs) for these products. The draft guidances are revised versions of previously published draft guidances on the subject.
77 FR 7586
https://www.govinfo.gov/app/details/FR-2012-02-13/2012-3233
2012-3233
fr13fe12-72
4160-01-P
Docket No. FDA-2007-D-0369
https://www.govinfo.gov/app/details/FR-2012-02-13/2012-3233
https://www.govinfo.gov/content/pkg/FR-2012-02-13/html/2012-3233.htm
https://www.govinfo.gov/content/pkg/FR-2012-02-13/pdf/2012-3233.pdf
2 p.
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77 FR 7586
Draft Guidance for Industry on Bioequivalence Recommendation for Nitroglycerin Metered Spray/Sublingual Products and Metered Aerosol/Sublingual Products; Availability; Federal Register Vol. 77, Issue
NOTICE
2012-3233
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
Docket No. FDA-2007-D-0369
4160-01-P
2012-3233
Notice.
The Food and Drug Administration (FDA) is announcing the availability of two draft guidances for industry entitled ``Bioequivalence Recommendations for Nitroglycerin,'' one for nitroglycerin metered spray/sublingual products and one for nitroglycerin metered aerosol/sublingual products. The recommendations provide specific guidance on the design of bioequivalence (BE) studies to support abbreviated new drug applications (ANDAs) for these products. The draft guidances are revised versions of previously published draft guidances on the subject.
Although you can comment on any guidance at any time (see 21 CFR 10.115(g)(5)), to ensure that the Agency considers your comment on the draft guidances before it begins work on the final versions of the guidances, submit either electronic or written comments on the draft guidances by April 13, 2012.
Doan T. Nguyen, Center for Drug Evaluation and Research (HFD-600), Food and Drug Administration, 7519 Standish Pl., Rockville, MD 20855, 240-276-8608.
Draft Guidance for Industry; Availability:
Bioequivalence Recommendation for Nitroglycerin Metered Spray/Sublingual Products, etc.
,
http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htm
http://www.regulations.gov
Federal Register
Vol. 77, no. 29
Office of the Federal Register, National Archives and Records Administration
2012-02-13
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Table of Contents:
AE 2.7:
GS 4.107:
AE 2.106:
KF70.A2
https://www.govinfo.gov/app/details/FR-2012-02-13
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0042-1219
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https://www.govinfo.gov/app/details/FR-2012-02-13
https://www.govinfo.gov/content/pkg/FR-2012-02-13/pdf/FR-2012-02-13.pdf
https://www.govinfo.gov/content/pkg/FR-2012-02-13/xml/FR-2012-02-13.xml
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