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.

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 Controls Section of a regulatory submission document included in an ANDA as set forth in 21 C.F.R. §314.94(a)(9).

Examples of CMC Section in a sentence

• 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.

• LANE is well positioned to accomplish this with our company’s top producing asphalt plant, located adjacent to I-264 and less than four miles from I-64.

• To the extent required, Bayer shall either: (i) be responsible for the preparation and delivery to Licensee of the Summary CMC Section in electronic and hard copy form and the latter in format suitable for inclusion in an NDA or NDA Equivalent in accordance with Applicable Laws and as the Parties may mutually agree; or (ii) provide Licensee with all data and information (including, without limitation, all Information) required to complete the Summary CMC Section in accordance with Applicable Laws.

• 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 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 control section of an Application for Regulatory Approval.

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(s) and data in the ANDA Filing.

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.

CMC Section means the chemistry, manufacturing, and controls section of the NDAs as defined in 21 CFR Section 314.50

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.