In this chapter, we have tried to highlight some of the steps being taken by the FDA to meet the challenges of nanotechnology products. The FDA has engaged in an open discussion with numerous groups and organizations, has participated in and sponsored workshops, has established internal working groups, has outlined a path for the review of combination nanotechnology products and has initiated research projects in nanotechnology. All these efforts have been geared towards a better understanding of the science and towards assessing the adequacy of existing regulations for the types of products that are expected to be regulated by the FDA.

At this point, and based on internal discussions, the FDA feels that its current regulations are adequate to address the types of nanotechnology products that are being developed as drugs or drug delivery systems. The reasons for this have been outlined in this chapter. Although there have been requests by investigators and developers of nanotechnology products for the FDA to issue nano-technology-specific guidances, no new guidance documents applicable specifically to nanotechnology products will be issued at this time. This is because it is felt that all existing Guidance documents apply to these products. All products being developed, whether nanotech-nology-based or not, are unique and therefore likely to have unique issues requiring consideration. As such, and as for all other products reviewed by the FDA, nanotechnology products will be reviewed on a case-by-case basis.

As shown in Figure 8.2, the drug development process is multiphasic and along the path, there are numerous opportunities for meetings between the sponsor and the FDA. The first meeting is the pre-IND meeting, and it is highly recommended that sponsors of nanotechnology products take the opportunity to meet with the FDA at this early stage. An early meeting with the FDA can avoid unnecessary or unfocussed studies that could result in a waste of sponsor resources. During early meetings, sponsors can present, with minimal data, their preclinical plans to the FDA and obtain guidance on how to focus the studies submitted in the IND package. This type of interaction between the FDA and the sponsor will be valuable to both parties and will pave the way for the most efficient drug development plan.

Basic research

Prototype design or discovery

Preclinical development

Clinical development

Phase 1 Phase 2 Phase 3

FDA filing/ approval &

launch preparation

Industry - FDA

interactions during development

Pre-IND meeting

Initial IND submissions

End of phase 2a meeting

End of phase 2 meeting

Ongoing submission

(Safety update

Market application submission

Pre-BLA or NDA meeting

IND review phase Application review phase

FIGURE 8.2 This figure depicts the extensive industry_FDA interactions that occur during product development, using the drug development process as a specific example.* Developers often meet with the agency before submitting an investigational new drug (IND) application to discuss early development plans. An IND must be filed and cleared by the FDA before human testing can commence in the United States. During the clinical phase, there are ongoing submissions of new protocols and results of testing. Developers often request additional meetings to get FDA agreement on the methods proposed for evaluation of safety or efficacy, and also on manufacturing issues. *Note: Clinical drug development is conventionally divided into three phases. This is not the case for medical device development. (From

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