CMC Section definition

CMC Section means the chemistry, manufacturing, and controls section of an NDA as defined in 21 CFR Section 314.50 (1) and its equivalent in other registration applications.
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CMC Section means the chemistry, manufacturing, and controls section of the Regulatory Application in the Territory as defined in 21 C.F.R. Section 314.50 (1), as may be amended from time to time.
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CMC Section means the Chemistry, Manufacturing and Controls Section of a regulatory submission document included in an ANDA as set forth in 21 C.F.R. Section 314.94(a)(9).
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Examples of CMC Section in a sentence

  • GIFT DISCLOSURESMayor DeLaRosa asked the members present if there were any agenda items that were a conflict of interest pursuant to CMC Section 2.04.030.

  • If a proposed modification is deemed urgent by the RAs, CMC Section B.12.9.5 will become active and the RAs will determine the procedure and timetable to be followed in the assessment of the Modification Proposal.

  • The Chief Procurement Officer will review the Selection Committee’s findings and will then submit a recommendation to the City Manager who will make the award for the City pursuant to CMC Section 321-65.

  • Pursuant to 1 CMC Section 7206, budget authority for the following activities is hereby approved.

  • Amendments specific to the Zoning Ordinance must follow the procedures listed in CMC Section 18.125.010 (Procedure).


More Definitions of CMC Section

CMC Section means a Chemistry, Manufacturing, and Control section of a Regulatory Approval, as mutually agreed to by the Parties.
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CMC Section means a dossier containing all Chemistry, Manufacturing and Controls documents in a form acceptable for filing with and approval by FDA and other Regulatory Authorities for inclusion by Supernus or its sub-licensees in their regulatory filings.
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CMC Section means the chemistry, manufacturing and controls section(s) and data in the ANDA Filing.
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CMC Section means the Section on chemistry, manufacture and control defined in 21 C.F.R. 312.23 (a) (7) or any successor to such provision, or a foreign equivalent thereof, and submitted by or on behalf of Meiji or Licensee to the FDA, or a foreign equivalent thereof, with respect to the Bulk or the Product, as applicable.
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CMC Section shall have the meaning set forth in Section 3(c).
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CMC Section means the Chemistry, Manufacturing and Control and Facilities section of the IND, NDA or SNDA, as the case may be, for the Product for the H-Indication or O-Indication.
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CMC Section means the Section on [ * ].
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