Citizen Petition (FDA) – Requesting withdrawal of drug dissolution apparatuses from FDA regulatory requirements

Today, I have submitted a Citizen Petition on the FDA site on the above mentioned subject (Tracking Number 1k2-94p3-9n4b). The content of the petition may be found here. I will keep you updated with the progress).

A revised Citizen Petition (with procedural/format adjustment) has been registered with the FDA (FDA-2018-P-3742) and can be found here (https://tinyurl.com/y9oaxe5t). (October 3, 2018)

Update:

Response from the FDA, as of April 1, 2019, “FDA has been unable to reach a decision on your petition because it raises complex issues requiring extensive review and analysis by Agency officials”. A copy of the letter is available from the FDA site (https://tinyurl.com/y9oaxe5t).

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