Hello,
With a change in sponsor from company A to company B (MAH transfer with FDA), how soon does Company B need to pull the products of Company A from the market and market products with Company B details?
Example: Company B received approval Dec 15, 2023, what is grace period before Company B can launch product with new labels, packaging material in the market with wholesalers, distributors etc to ensure patients have adequate supply during this transfer period.
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Himani Parikh RAC
Associate Director, Regulatory Affairs
Allen TX
United States
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