Appealing an FDA PMTA Marketing Denial Order (MDO) - Is It Possible? скачать в хорошем качестве

Appealing an FDA PMTA Marketing Denial Order (MDO) - Is It Possible?

Did you submit a U.S. Food and Drug Administration (FDA) Premarket Tobacco Product Applications (PMTA) and it has been denied?  If so, you’re not alone. For the thousands of brands selling millions of newly deemed tobacco products - mostly vapor products, referred to as electronic nicotine delivery systems, or “ENDS,” who managed to submit the required U.S. Food and Drug Administration (FDA) Premarket Tobacco Product Applications (PMTA) by the September 9 deadline last year, it likely came as a shock to learn that FDA has now taken action on upwards of 90% of applications only one year later.  A significant number of applications received a Refuse-To-File (RTF) or Marketing Denial Order (MDO). It is possible to submit an appeal to the FDA’s decision.  Despite these discouraging developments, affected businesses should not simply toss their FDA notices (and businesses) in the dust bin – depending on FDA’s stated reasoning, adverse agency decisions, such as marketing denial orders, can be appealed through a written request to the FDA.  For whom questions remain - we encourage you to contact us for assistance.  *** DISCLAIMER: Our videos are not intended to be, nor should be construed as, legal advice nor creating an attorney-client relationship. ©2023 by the Clark-Esposito Law Firm, P.C. May be considered attorney advertising in some jurisdictions. *** We are determined to help you. We listen carefully to clients to ensure our understanding of the legal issues at hand, their factual context, and any limitations that might impact a chosen strategy. To learn more about our firm or connect with us visit the links below. Email: [email protected] Website: https://www.clarkespositolaw.com Blog: https://www.clarkespositolaw.com/lega... LinkedIn:   / admin   Facebook:   / clark-esposito-law-firm-pc-100529905686343   Instagram:   / clarkespositolawfirm   Music: https://www.bensound.com In some jurisdictions, this may be considered attorney advertising.