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.

CMC Section means the chemistry, manufacturing and control section of an Application for Regulatory Approval.

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.

• In circumstances where the third party is entitled to, or is likely to be able to obtain, access to the CMC Section, the prior written consent of Elan shall be obtained to any sub-licence or other agreement permitted by this Article 2.

• Elan shall manufacture or procure the manufacture the Product under this Agreement in conformity with the Specifications, the relevant portions of the CMC Section and, if applicable, the DMF and in a manner which fully complies with all United States of America and foreign statutes, ordinances, regulations and practices.

• Elan shall indemnify and hold harmless Acorda, its agents and employees from and against all claims, damages, losses, liabilities and expenses to which Acorda, its agents, and employees may become subject related to or arising out of Elan’s bad faith, gross negligence or intentional misconduct in connection with the preparation of the CMC Section.

More Definitions of CMC Section

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. §314.94(a)(9).

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.

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.

CMC Section means the chemistry, manufacturing and controls section(s) and data in the ANDA Filing.

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.

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.

CMC Section means the chemistry, manufacturing and controls section(s) and data in the ANDA Filing. “Competitor” means: (a) Tris Pharma, Inc. or its successors and Affiliates, or (b) UCB or its successors and Affiliates.