It should also be emphasized that the amount of information to be submitted depends upon the scope of the proposed clinical investigation. For example, although stability data are required in all phases of the IND to demonstrate that the new drug substance and drug product are within acceptable chemical and physical limits for the planned duration of the proposed clinical investigation, if very short-term tests are proposed, the supporting stability data can be correspondingly limited and so on...meeting the minimum CMC requirements at each stage is a major challenge, and really is the key to developing a successful overall strategy. The data availible as development data should have an upward slope. Many forget this, and just review the minimum requirements for CMC as a step function. This may lead to near panic when there product rapidly shows clinical efficacy, and they then realize how far behind they are in being at the CMC level expected by the agency. Content strategy needs to be periodically assessed to ensure that the plan in keeping pace with any new expectations.
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Edward Narke
Regulatory Managing Director
DS InPharmatics
Phoenixville PA
United States
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Original Message:
Sent: 11-29-2012 06:57
From: Beverly Lewis
Subject: CMC requirements
This simplest answer is that Competent Authorities expect an increased level of detail for CMC information as one progresses through development. In the US, CMC requirements for Phase 1 are described in the guidance Content and Format of Investigational New Drug Applications (INDs) for Phase 1 Studies of Drugs Including Well-Characterized, Therapeutic, Biotechnology-Derived Products. The Phase 2/3 requirements are described in the Guidance INDs for Phase 2 and Phase 3 Studies Chemistry, Manufacturing, and Controls Information and the Draft Guidance INDs for Phase 2 and 3 Studies of Drugs, Including Specified Therapeutic Biotechnology-Derived Products Chemistry, Manufacturing, and Controls Content and Format. These guidances are available on the FDA web site.
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Beverly Lewis RAC
Lewis CMC Consulting Inc
Nags Head NC
United States
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Original Message:
Sent: 11-28-2012 12:29
From: Andre Pearson
Subject: CMC requirements
How are the CMC requirements different for phase I, phase II, and phase III?
Thanks.
Andre
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Andre Pearson
BIOTECH GENERICS LLC
Brooklyn NY
United States
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