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2014-12-24
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Bioequivalence Recommendations for Methylphenidate Hydrochloride Extended-Release Oral Suspension; Draft Guidance for Industry; Availability
Notices
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United States
Department of Health and Human Services
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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The Food and Drug Administration (FDA) is announcing the availability of a draft guidance for industry entitled ``Bioequivalence Recommendations for Methylphenidate Hydrochloride Extended-Release Oral Suspension.'' The recommendations provide specific guidance on the design of bioequivalence (BE) studies to support abbreviated new drug applications (ANDAs) for methylphenidate hydrochloride (HCl) extended- release oral suspension.
79 FR 77515
https://www.govinfo.gov/app/details/FR-2014-12-24/2014-30109
2014-30109
fr24de14-84
4164-01-P
Docket No. FDA-2007-D-0369
https://www.govinfo.gov/app/details/FR-2014-12-24/2014-30109
https://www.govinfo.gov/content/pkg/FR-2014-12-24/html/2014-30109.htm
https://www.govinfo.gov/content/pkg/FR-2014-12-24/pdf/2014-30109.pdf
2 p.
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79 FR 77515
Bioequivalence Recommendations for Methylphenidate Hydrochloride Extended-Release Oral Suspension; Draft Guidance for Industry; Availability; Federal Register Vol. 79, Issue
NOTICE
2014-30109
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
Docket No. FDA-2007-D-0369
4164-01-P
2014-30109
Notice.
The Food and Drug Administration (FDA) is announcing the availability of a draft guidance for industry entitled ``Bioequivalence Recommendations for Methylphenidate Hydrochloride Extended-Release Oral Suspension.'' The recommendations provide specific guidance on the design of bioequivalence (BE) studies to support abbreviated new drug applications (ANDAs) for methylphenidate hydrochloride (HCl) extended- release oral suspension.
Although you can comment on any guidance at any time (see 21 CFR 10.115(g)(5)), to ensure that the Agency considers your comments on this draft guidance before it begins work on the final version of the guidance, submit either electronic or written comments on the draft guidance by February 23, 2015.
Kris Andr[eacute], Center for Drug Evaluation and Research (HFD-600), Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 75, Rm. 4726, Silver Spring, MD 20993-0002, 240-402-7959.
Guidance:
Bioequivalence Recommendations for Methylphenidate Hydrochloride Extended-Release Oral Suspension
,
http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htm
http://www.regulations.gov
Federal Register
Vol. 79, no. 247
Office of the Federal Register, National Archives and Records Administration
2014-12-24
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Table of Contents:
AE 2.7:
GS 4.107:
AE 2.106:
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https://www.govinfo.gov/app/details/FR-2014-12-24
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