(NHI Nanoblog) POTOMAC, Md. — The U.S. Food and Drug Administration is still evaluating whether its policies need tweaking to deal with the increasing development of drugs that use nanomaterials, but the agency’s current procedures are “adequate” for the time being, an official told a conference here.
Nakissa Sadrieh, associate director of research and policy implementation in the FDA’s Office of Pharmaceutical Science, said that the agency’s existing guidelines for submitting new products for approval should cover most questions for applicants.
“There’s no need right now … to issue guidance documents specifically for nanomaterials,” Sadrieh said. “The existing framework can accommodate the kind of nanoparticle therapeutics under development.”
Sadrieh spoke at a conference jointly hosted by the the American Society for Nanomedicine and National Institutes of Health’s Office of Aids Research and the Division of AIDS at the NIH’s National Institute of Allergy and Infectious Diseases. The main theme involved growing efforts to put nanotechnology to use in preventing and treating HIV, and eventually developing a vaccine for the infection.
Pressed by some in the audience about anxiety among drug developers — particularly academics — who want more specifics from the FDA, Sadrieh said additional guidelines are probably unnecessary. That’s because the agency regards the process of considering nanomaterials derived from drugs and other substances that have already been approved as fairly similar to the current procedures. She added that specificity will come in individual interactions between applicants and the agency.
“We’re viewing nanoparticle-containing drugs as just new drugs,” Sadrieh said.
Because super-small nanomaterials are part of such a broad category, it’s difficult to generalize and create one-size-fits-all guidelines, she said.
The FDA is in the process of putting together a database of both approved drugs and materials that are under review. Sadrieh stressed that the burden is on applicants to understand their material deeply, in order to provide the best information for the FDA when seeking approval for new things. That means being able to specify all of the materials involved, their stability, and how to achieve a consistent method of quality control.
