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Information For:
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Modafinil: Notice of Intent to Revise
In accordance with the 2005-2010 Rules and Procedures of the Council of Experts, the Monograph Development–Pulmonary and Steroids Expert Committee intends to revise the Modafinil monograph based on comments received. Several specifications will be updated pending final FDA approval for tentatively approved Abbreviated New Drug Application (ANDA) holders. It is anticipated that the proposed revisions will be published as a Revision Bulletin. Should you have questions, please contact Mary Waddell (301-816-8124 or ). What's New
 USP recalled USP 33-NF 28 on Jan. 8, 2010. A reissue product will be available in April 2010.
PF 36(2), March-April 2010: IRAs and Errata (03/01/10) February Revision Bulletins (02/26/10) Protamine Monographs: Notice of Intent to Revise (02/26/10) New Draft Pending Standard for the month of February (02/26/10) PF 36(2), March-April 2010: Highlights (02/22/10) Calculation Tool for the Performance Verification Test (PVT) of Dissolution Assemblies (02/22/10) Performance of Equipment to Test Dissolution of Medications Further Assured (02/09/10) New Official Text (01/29/10) Related Resources |
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Copyright © 2010 The United States Pharmacopeial Convention
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