FDA refining nanotechnology guidance

By Nick Taylor

- Last updated on GMT

Related tags Fda Nanotechnology

The US Food and Drug Administration (FDA) is seeking feedback from the pharmaceutical industry to develop the recommendations of the Nanotechnology Task Force.

By gathering the industry’s views on the task force’s report​ the FDA is hoping to refine its guidance on the growing field of nanotechnology.

Given the concerns in some quarters over the potential unintended effects of nanotechnology, creating a comprehensive regulatory system is seen as key to ensuring the safe implementation of the technology.

Consequently the FDA is seeking the industry’s views on: “The information and data that may be needed to demonstrate the safety and effectiveness of FDA-regulated products containing nanoscale materials and the circumstances under which a product's regulatory status might change due to the presence or use of nanoscale materials​.”

In particular the FDA wants to specify what characteristics of nanoparticles should be used to evaluate their safety and the tools that will be necessary to do so.

The FDA is also seeking information on the availability, practicality and reliability of these tools and has stated it will work with the industry to develop new techniques if necessary.

A detailed overview of the manufacturing process is also being sought, with the FDA keen to gain an insight into any nuances unique to nanotechnology.

The challenge posed by scaling-up production to commercial levels is one aspect the FDA highlights. In addition the agency focuses on the characteristics of nanoparticles that need to be considered when developing “controls, standards and specifications for manufacturing​”.

Looking further along the supply chain the FDA is seeking input into how storage may affect the safety and efficacy of products containing nanoparticles, including when they are used as excipients.

This will be used to develop a policy for how products containing nanoparticles need to be treated throughout the distribution network.

Those contributing to the discussion are encouraged by the FDA to raise any pertinent issues that may have slipped the agency’s attention.

The public meeting will be held in Maryland​ on September 8 and those wishing to contribute must register and submit an electronic copy of their presentation by September 2. Electronic comments may be submitted here​ until October 24.

Related topics Formulation & Science

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