Regulatory Open Forum

Dear all,


we have one query that For MR dosage form SUPAC level 1 change in controlled release excipient(which is annually reportable),Can we make commercial batch release batch and sell it before annual report submission or is it mandatory to get approval from FDA for level 1 change before selling of product.

Your guidance highly appriciated.

Regards,

Sapna

If it is a confirmed Level 1 change (after all the internal Change control process) and it is annual reportable, one can release the batch and sell before the AR submission!