Sidling up to the complexities of nanotechnology in drug bioavailability, formulation and delivery, FDA Commissioner Margaret Hamburg notes that a recently issued draft guidance avoids an actual definition of the technology. But as a first step, she wants to "narrow the discussion" with industry to such points as size parameters and properties of the materials to see if they are "an appropriate starting place," reports Mark Senak in last week's Eye on Pharma roundup.
The draft guidance, Considering Whether an FDA-Regulated Product Involves the Application of Nanotechnology, marks five years of effort by the FDA Nanotechnology Task Force. It was formed in 2006, and the following year issued a report recommending the regulator issue guidance on nanotech.
Separately, and in stark contrast to the tentative nature of the nanotech pre-guidance, the FDA's Center for Drug Evaluation and Research announced the emergence of a frightening-sounding "Super Office" from the somewhat less intimidating Office of Compliance. Fortunately--and inexplicably--it will still be called the Office of Compliance.
It's part of a "major structural reorganization," according to Pharmaceutical Technology. Staff will be realigned by function under the new structure.
As a "Super," the Office of Compliance will house subordinate offices. Some will be similar to existing units. For example, the Office of Drug Security, Integrity & Recalls, will focus on such global-level supply chain issues as security, counterfeit and diverted drugs, economically motivated adulteration, import operations and drug recalls.