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

  • In the event that there is a deficiency in the CMC Section attributable to negligence by Elan in the activities conducted by Elan, then Elan shall be responsible for correcting such deficiency, at Elan’s expense, and shall use reasonable efforts to do so as soon as practicable.

  • Acorda shall provide Elan as soon as practicable with a copy of any comments received by Acorda from the FDA or any other regulatory authority relating to the CMC Section and Elan shall provide or, at Acorda’s request, cooperate with Acorda to provide, a response to such comments as soon as practicable.

  • Leave under the provisions of this Article shall be limited to four (4) months (nine [9] pay periods [720 hours]) during a twelve (12) month period, regardless of the number of incidents.

  • Where floors, walls, ceilings or any other portion of the building or structure are required to be altered or replaced in the process of installing or repairing any system, the building or structure shall be left in a safe structural condition in accordance with the CMC Section 303.

  • Condensate drain systems shall be designed, constructed and installed in accordance with the CMC Section 310.


More Definitions of CMC Section

CMC Section means the chemistry, manufacturing and control section of an Application for Regulatory Approval.
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CMC Section means the chemistry, manufacturing, and controls section of the Regulatory Filing, as defined in the CFR, as may be amended from time to time, and/or its equivalent in other 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 chemistry, manufacturing, and controls section of the NDAs as defined in 21 CFR Section 314.50
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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 “Chemistry, Manufacturing and Controls” section of a NDA, or the comparable section of an MAA for any other jurisdiction, with respect to Product.
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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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