CBE 30 definition

CBE 30 means a regulatory submission to the FDA at least thirty days prior to distribution of Product indicating changes being effected to the NDA 16-151 as defined in 21 CFR 314.70(c).
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Examples of CBE 30 in a sentence

  • KING shall provide NOVAVAX with all information necessary to submit such CBE 30.

  • ANI will perform and/or provide all testing, documentation and support needed for submission and approval of a CBE 30 of the Product.

  • NOVAVAX shall provide PHARMELLE with all information applicable to NOVAVAX that is necessary to include in such CBE 30 filings promptly upon PHARMELLE’s request.

  • As requested by CLP, ANI will perform all stability studies and reporting to support a submission and approval of a CBE 30 for the Product as well as all on-going stability required for the Product.

  • Aesica will be responsible for filing and obtaining any necessary Governmental or Regulatory Authority approval (CBE 30) for any process change in the manufacture of the Drug Substance.

  • ANI will provide and/or purchase all necessary equipment including but not limited to, blenders and mixers to manufacture the Product according to Specifications and to support the submission and approval of a CBE 30.