Regulatory Body Interactions

Kymanox has over 80 combined years of FDA and industry experience and over 70 health authority interactions across many products and indications. Our regulatory team interacts on behalf of our clients with regulatory bodies and health authorities to lead various filing activities (e.g., DUFA, BsUFA, GDUFA, and Q-submission meetings) and to lead negotiations that resolve issues and respond effectively to 483s, warning letters, consent decrees, and complete response letters.
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Meeting Facilitation

Kymanox can help facilitate meetings with regulatory bodies such as Type A, Type B (Pre-IND, EOP2, Pre-NDA/BLA), Type C, INTERACT, Q-submission, BIA, BPD, and Combination Product Agreement meetings with the FDA.
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Filing Support

Kymanox can author, review, and submit meeting request and support documentation, including serving as the regulatory point of contact to hit your submission deadlines.
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Information Requests

The Kymanox regulatory team has supported many clients after submission by authoring and reviewing responses to Information Requests and 483s to ensure timely and complete responses.

Frequently Asked Regulatory Affairs Questions (FAQs)

Does the FDA approve cosmetics before they go on market?
Cosmetic products and ingredients are not subject to FDA premarket approval authority, with the exception of color additives (other than those intended for use as coal-tar hair dyes). FDA's authority over cosmetics is post-market. FDA may take regulatory action if it has information to support that a cosmetic is adulterated or misbranded. The agency can pursue action through the Department of Justice in the federal court system to remove adulterated and misbranded cosmetics from the market. 
What is the definition of General Wellness Product?
A general wellness product has (1) an intended use that relates to maintaining or encouraging a general state of health or a healthy activity, or (2) an intended use that relates the role of healthy lifestyle with helping to reduce the risk or impact of certain chronic diseases or conditions and where it is well understood and accepted that healthy lifestyle choices may play an important role in health outcomes for the disease or condition. 
What is Software as a Medical Device?
Software as a Medical Device (SaMD) is often described as “software intended to be used for one or more medical purposes without being part of a hardware medical device."  Use of SaMD is continuing to increase.  It can be used across a broad range of technology platforms, including medical device platforms, commercial "off-the-shelf" platforms, and virtual networks, to name a few. Such software was previously referred to by industry, international regulators, and health care providers as "standalone software," "medical device software," and/or "health software." 
With which regulatory filings can Kymanox assist?
Kymanox interacts on behalf of our clients with regulatory bodies and health authorities to lead various filing activities (e.g., IDE, PMA, IND, NDA, BLA) and to lead negotiations that resolve issues and respond effectively to 483s, Warning Letters, Consent Decrees, and Complete Response Letters. 
Can Kymanox handle regulatory submissions outside the U.S.?
Yesthe Kymanox team is experienced with the regional regulatory requirements and expectations for submissions to EU, Japan, Brazil, and Canada.