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U.S. Department of Health and Human Services

About FDA

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General E-mail Questions to ONDQA


You may send questions to ONDQA using the following e-mail address: newdrugcmc@fda.hhs.gov. This e-mail account is intended to be used for external stakeholders asking general CMC or biopharmaceutics questions or requesting guidance on general matters that affect multiple applications or issues that cross ONDQA organization units. It should not be used for single product/application specific questions. Single product/application specific questions should not be sent through this e-mail account, but instead must go through the appropriate ONDQA Regulatory Project Manager.