It appears to me that the FDA is increasing its use of medical products harmonization document as a source for regulatory guidance in recent years. For example, during the Pharmaceutical Quality Symposium in October, Tara Groen and Rapti Maudurawe of the FDA noted the agency will not pursue the draft guidance on continuous manufacturing but will focus instead on the upcoming ICH Q13 guidance (which is still in the early stages, see the working group links here),
We are also seeing increased references to the work of the International Medical Device Regulators Forum, WHO quality standards for drugs and medical devices, and the Pharmaceutical Inspection Cooperation Scheme (PIC/S). These efforts should someday result in a more consistent global path for medical products to reach patients in need.
Reach out to me if you want to know more or discuss your medical product development challenges.
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