Regulatory Open Forum

We are entering Phase 3 and planning to use plain tablets with no markings for both active and placebo. We will include an ink marking when we manufacture registration batches to support NDA approval. Some people at my company are questioning whether the Phase 3 clinical supplies need to have a marking since that's what we plan to use for commercial.  Is this a requirement for Phase 3? I did not think it was.

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Tom Stothoff
Senior Director, Regulatory Affairs CMC
Chicago
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Not a requirement but the question is adding ink to the registration tablets would have to be placed on stability(with a commitment to submit updated data in the AR) .  You may have to think about delay in NDA submission because you may not have 12 months data for submission.

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GRSAOnline
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Original Message:
Sent: 24-Jun-2022 15:06
From: Tom Stothoff
Subject: Tablet ink marking on Phase 3 tablets

We are entering Phase 3 and planning to use plain tablets with no markings for both active and placebo. We will include an ink marking when we manufacture registration batches to support NDA approval. Some people at my company are questioning whether the Phase 3 clinical supplies need to have a marking since that's what we plan to use for commercial.  Is this a requirement for Phase 3? I did not think it was.

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Tom Stothoff
Senior Director, Regulatory Affairs CMC
Chicago
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