Wellbeing Digital Sciences (NEO:MEDI.AQN, OTCQB:KONEF) Inc said its KGK Science Inc subsidiary applauds the efforts of the US Food and Drug Administration (FDA) to release the recent New Dietary Ingredient (NDI) enforcement draft guidance, which is part one of a multipart series of NDI guidance documents the FDA announced during a round table discussion at the International Probiotics Association (IPA) World Congress + Probiota Americas.
The mental healthcare company noted that according to the FDA, the recent enforcement discretion guidance on late submissions of NDI notifications, released on May 19, 2022, was in response to its commitment in the fall of 2021 to update guidelines in 2022.
It added that instead of releasing a single guidance document containing all issues for stakeholder notice and comment for a third time, the FDA plans to release separate and smaller draft guidance with FDA’s thinking on each group of NDI topics.
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“Future draft guidance documents from the Agency on NDIs are critical to the probiotic industry and many of our KGK Science clients,” Wellbeing Digital Sciences (NEO:MEDI.AQN, OTCQB:KONEF) CEO Najla Guthrie said in a statement.
As well, the company said the IPA, in conjunction with its US Task Force Leader and KGK Science chief scientific affairs and regulatory officer Dr Corey Hilmas, has initiated discussions with industry leaders to formally request a public meeting with the FDA to discuss issues that directly apply to probiotics.
Wellbeing Digital Sciences (NEO:MEDI.AQN, OTCQB:KONEF) is an evidence-based mental healthcare company focused on the development and implementation of innovative clinical solutions, including psychedelic medicine and digital therapeutics, as supported by clinical research.
Its mission is supported by a network of North American clinics that provide forward-thinking therapies and other types of treatment to patients as well as through a contract research organization that offers clinical trial services to clients pursuing drug development.
Contact Sean at sean@proactiveinvestors.com