FDA is a stricter regulator and puts way more focus on efficacy than CE. TGA is just a gimmick that will approve anything that is CE or FDA approved. FDA wants to approve stuff that it thinks is safe, otherwise it opens itself up to legal challenges. I don't buy that they're fulfilling a protectionist agenda as some have suggested, they clearly have genuine concerns.
FDA is a stricter regulator and puts way more focus on efficacy...
Currently unlisted. Proposed listing date: 4 SEPTEMBER 2024 #
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