Does the U.S. Food and Drug Administration, the European Medicines Agency, and other regulatory agencies accept OEL Fastrac monographs with ADEs?
OEL Fastrac monographs have been sold in over 47 different countries. We have never had a regulatory agency reject our monographs.
In one case we had a regulatory agency question why we used the lowest daily therapeutic dose instead of the NOAEL when calculating the ADE. Unfortunately, this was due to the agency’s lack of toxicology knowledge. Once, we explained the rationale, the agency accepted our approach.
At Affygility Solutions, we survey our customers to get feedback on the monographs. Recently, one client had the Medicines and Healthcare Products Regulatory Agency (MHRA) request to examine one of the monographs. The client stated, “The MHRA reviewed one our your monographs recently and the statement was ‘that is what I was looking for’.”
One of the benefits of OEL Fastrac monographs is that you are getting documents that get reviewed by many agencies and quality personnel throughout the world. We gather any feedback from these sources and continuously make improvements to the documents.
As you know, regulatory agencies are prohibited from endorsing any private companies approach.
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