Regulating Nanomedicine at the Food and Drug Administration

Abstract

The US Food and Drug Administration (FDA) oversees safety and efficacy of a broad spectrum of medical products (ie, drugs, biologics, and devices) under the auspices of federal legislation and agency regulations and policy. Complex and emerging nanoscale products challenge this regulatory framework and illuminate its shortcomings for combination products that integrate multiple mechanisms of therapeutic action. This article surveys current FDA regulatory structures and nanotechnologyspecific guidance, discusses relevant nanomedicine products, and identifies regulatory challenges. Regulatory Demands of NanotechnologyNanotechnology is research and technology development on the nanoscale (traditionally 100 nanometers (nm) or less, or one billionth of a meter) at which particles have novel properties and functions because of their size. 1 At this size, materials exhibit quantum effects, impacting fluorescence, conductivity, magnetic permeability, melting point, and reactivity. 1 The ability to control atoms and molecules at the nanoscale has significantly advanced medical science and catalyzed the field of nanomedicine, defined by the National Institutes of Health as a "highly specific medical intervention at the molecular scale for curing disease or repairing damaged tissues, such as bone, muscle, or nerve." 2 Nanomedicine also includes nanotechnology applications for "diagnosis, monitoring, and control of biological systems." 3 Cutting-edge nanomedicine applications often integrate chemical, mechanical, and biological properties to enable and enhance detection, diagnostic capabilities, and therapeutic modes of action. In the near future, it will be possible for a single nanomedicine product, once deployed in a patient's body, to be programmed to target specific organs and tissues, create images, measure vital signs, diagnose in real time, and subsequently provide tailored therapeutics.

Nanotechnology-Based Celastrol Formulations and Their Therapeutic Applications

“…More importantly, the universal challenge of clinical translation of nanomedicine needs more attention, and as rightly pointed out by Sun et al (2020), pharmaceutical scientists, engineers, chemists, and material scientists must work in synergy to develop stable, scalable, and effective nanoformulations. Furthermore, regulatory authorities worldwide are developing specific guidelines to streamline the approval of nanomedicinebased products that would help in successful clinical translation of these formulations in the near future (Paradise, 2019).…”

Nanotechnology, Nanomedicine, and the Kidney

“…Thus far, the US Food and Drug Administration (FDA) continues to evaluate nanotechnology products on a case-by-case basis, using the combination product framework to establish the type of product and the resulting regulatory requirements [99]. However, more and more, medical, scientific, and legal authorities, such as the National Academy of Medicine [100], have repeatedly urged the FDA to correct inconsistent and inadequate classifications, as well as the combination product framework itself.…”

“…However, more and more, medical, scientific, and legal authorities, such as the National Academy of Medicine [100], have repeatedly urged the FDA to correct inconsistent and inadequate classifications, as well as the combination product framework itself. In her survey, Paradise [99] identifies that, as nanomedicine progresses, the FDA faces various challenges, three of which stand out: (i) is the regulatory framework adequate in regulating this technology as distinctions usually used and their legal requirements may not be ideal? (ii) What are the potential novel risks and traditional safety and efficacy requirements appropriate?…”

“…(ii) What are the potential novel risks and traditional safety and efficacy requirements appropriate? (iii) Is the labeling of nanomedicine products for consumers sufficient to inform them about nanotechnology or nanomaterials containing products [99]? To the first point, Allon et al, believe that nanomedicine does not constitute a separate, distinct, or exceptional discipline from an ethical standpoint and, therefore, does not necessitate special regulatory treatments to address the challenges posed by this emerging technology platform.…”

<p>Species-Specific in vitro and in vivo Evaluation of Toxicity of Silver Nanoparticles Stabilized with Gum Arabic Protein</p>

“…Nanotechnology provides a myriad of opportunities for the development of materials from one to 100 on the nanometers scale. [1][2][3][4][5][6][7][8][9][10][11][12][13] Among the wide spectrum of nanomaterials in current use, silver nanoparticles (AgNPs), have gained considerable prominence attributed by their excellent physiochemical properties such as antimicrobial activity, good conductivity, and high catalytic activities. [14][15][16][17][18][19] The use of AgNPs in healthcare have found applications in treating infections, preventing bacterial and fungal colonization on denture surfaces, decontamination of catheters and dental materials.…”