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Hi Joy, Thank you for the information. I work in medical devices so I wasn't aware of the reform to OTC drugs. ------------------------------ Pam Martin, RAC, MSc Regulatory Affairs Project Manager KLS-Martin L.P. Jacksonville, FL USA ------------------------------

Hi Victor, I have limited information from the client about the OTC product, but my assumption is this might be an (A)NDA submission rather than OTC monograph. Either way, I'm open to your recommendations if this ends up going the OTC monograph route. Thank you very much for the information! ...

Good Morning, I'm looking for recommendations for a firm or consultant that has experience in submitting OTC drugs to the US FDA. Thank you! ------------------------------ Pam Martin, RAC, MSc Regulatory Affairs Project Manager KLS-Martin L.P. Jacksonville, FL USA ----------------------- ...

True ------------------------------ Pam Martin, RAC, MSc Regulatory Affairs Project Manager KLS-Martin L.P. Jacksonville, FL USA ------------------------------

Hello Arina, I suggest contacting the Border Integrity Unit. I've had success with getting import and customs questions answered by them fairly quickly: Border Integrity Unit / Unité d'Intégrité Frontalière Health Products and Food Branch Inspectorate / Inspectorat de la Direction générale des ...