Drug Regulatos, FDA, Reppost Guidance on CMC Submissions for Therapeutic Recombinant DNA-Derived Products or Monolconal Antibody Products

The FDA has re-posted guidance first published in 1996 “FOR THE SUBMISSION OF CHEMISTRY, MANUFACTURING, AND CONTROLS INFORMATION FOR A THERAPEUTIC RECOMBINANT DNA-DERIVED PRODUCT OR A MONOCLONAL ANTIBODY PRODUCT FOR IN VIVO USE

This guidance provides a section by section description of the Chemistry, manufacturing and control section of an FDA submission, its aimed specifically at Specific Biotech products, but should be considered by other related technologies. There is no apparent reason for the re-posting but it could be the FDA is planning an update.

If you would like more detail in this area please get in touch with Damien Bové damien.bove@idaconsultants.com


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Damien Bové is the drug development and regulatory consultant (pharmaceutical or biotechnology), I work with my clients to define a drug development target, define a drug development strategy, define a regulatory strategy or define a commercial strategy. Our clients are generally raising funds or looking to license out their technology and we help them achieve it. If you want to know more don’t hesitate to get in touch.


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