Examples of CMC Information in a sentence
Notwithstanding anything in this Agreement to the contrary, during the POC Term for a given Program, except with respect [***], Moderna may redact from documents provided or made available to Merck or its Affiliates, and otherwise decline to disclose or provide Merck access to, Moderna CMC Information and proprietary manufacturing processes relating to Moderna CMC Information from such Program.
This guidance applies to human gene therapy products and to combination products1 that contain a human gene therapy in combination with a drug or device.2 This guidance finalizes the draft guidance of the same title dated July 2018 and supersedes the document entitled “Guidance for FDA Reviewers and Sponsors: Content and Review of Chemistry, Manufacturing, and Control (CMC) Information for Human Gene Therapy Investigational New Drug Applications (INDs),” dated April 2008 (April 2008 guidance).
Guidance for Industry: Chemistry, Manufacturing, and Control (CMC) Information for Human Gene Therapy Investigational New Drug Applications (INDs) (U.S. Department of Health and Human Services).
See for example FDA, “Chemistry, Manufacturing and Control (CMC) Information for Human Gene Therapy Investigational New Drug Applications (INDs),” July 2018, https://www.fda.gov/downloads/BiologicsBloodVaccines/ GuidanceComplianceRegulatoryInformation/Guidances/CellularandGeneTherapy/UCM610795.pdf.
This guidance finalizes the draft guidance entitled, “Guidance for FDA Review Staff and Sponsors: Content and Review of Chemistry, Manufacturing, and Control (CMC) Information for Human Gene Therapy Investigational New Drug Applications (INDs)” dated November 2004 (69 FR 64958; November 9, 2004).