Moving towards in vitro from a regulatory perspective: Considerations from the FDA Modernization Act 2.0
Axol Bioscience caught up with Simon Hoffman, Principle Quality Assurance & Regulatory Consultant to hear what he thought of the FDA Modernization Act 2.0 and how it will impact drug discovery. Here’s a snippet from the interview.
Q Thanks for your time, Simon. Let’s start at the top: what is the FDA Modernization Act 2.0?
This bill authorizes the use of certain alternatives to animal testing, including cell-based assays and computer models, to obtain an exemption from the Food and Drug Administration to investigate the safety and effectiveness of a drug.
The bill has been passed by the Senate to end animal testing mandates.
Q What does the Act change?
In straightforward terms, the act removes the necessity to utilize animal studies to prove the safety and efficacy of a medicinal substance. However, it should duly be noted that the act effectively details an alternative, not a complete replacement. It effectively allows certain animal testing alternatives, including cell-based assays and computer models. It is not mandating that animal testing will, or indeed necessarily should, be replaced – it is more effectively ending the mandating of animal testing.
However, it is probably just as vital to note what the act does not change. It is still an absolute necessity to objectively verify the safety and efficacy of medicinal products to the same statistically proven degree. I therefore cannot stress enough, from a safety and efficacy perspective, the act is by no means a “shortcut”.
Indeed, based on many years of experience and monitoring the approach to FDA inspections, the introduction of a new guidance document or bill often leads to enhanced scrutiny and assertion of regulatory requirements – the FDA are often under the microscope themselves. Add this to the recent publicity of the Covid-19 pandemic, and the whole world literally hanging on daily updates relating to clinical trials and the like, the scrutiny is only like to increase, which goes hand-in-hand with increasing standards and demands.
You can read the full interview here – https://axolbio.com/moving-towards-in-vitro-from-a-regulatory-perspective-considerations-from-the-fda-modernization-act-2-0/
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