What are the Regulatory Pathways for Nanomedicine?
Nanomedicine, which involves the application of nanotechnology in healthcare, follows specific regulatory pathways:
Drug Products: Nanopharmaceuticals are regulated as drugs and must undergo rigorous testing, including preclinical studies, clinical trials, and post-market surveillance. Medical Devices: Nanotechnology-enabled medical devices follow a different pathway, often requiring 510(k) clearance or Premarket Approval (PMA) depending on the risk classification. Combination Products: Products that combine drugs, devices, or biological products may require a combination of regulatory pathways and coordination between multiple regulatory bodies.
