FDA Issues Draft Guidance on Nanotechnology - Pharmaceutical Technology

Latest Issue

Latest Issue
PharmTech Europe

FDA Issues Draft Guidance on Nanotechnology

ePT--the Electronic Newsletter of Pharmaceutical Technology

Nanotechnology is science involving particles less than 100 nm in size. It is an emerging technology that is finding applications in medical products, food packaging, and cosmetics. Nanoscale materials can have different chemical, physical, or biological properties than their conventionally-scaled counterparts. As a first step in providing regulatory clarity about the use of such technology, FDA issued a draft guidance, titled “Considering Whether an FDA-Regulated Product Involves the Application of Nanotechnology” on June 9, 2011. The guidance lists points that FDA will consider when determining whether a product applies nanotechnology, and explains rationales for those points.

For products subject to premarket review, FDA intends to apply the points contained in the draft guidance, when finalized, to better understand the properties and behavior of engineered nanomaterials. For products not subject to premarket review, FDA will urge manufacturers to consult with the agency early in the product development process so that questions related to the regulatory status, safety, effectiveness, or public-health effects of these products can be adequately addressed. The guidance does not provide a regulatory definition of nanotechnology.

Comments and suggestions regarding the draft guidance should be submitted within 60 days of its publication in the Federal Register. Written comments can be submitted to the Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Ln., Rm. 1061, Rockville, MD 20852. Electronic comments can be sent to http://www.regulations.gov. All comments should be identified with the docket number (FDA-2010-D-0530) listed in the notice of availability published in the Federal Register.


blog comments powered by Disqus
LCGC E-mail Newsletters

Subscribe: Click to learn more about the newsletter
| Weekly
| Monthly
| Weekly

Which of the following business challenge poses the greatest threat to your company?
Building a sustainable pipeline of products
Attracting a skilled workforce
Obtaining/maintaining adequate financing
Regulatory compliance
Building a sustainable pipeline of products
Attracting a skilled workforce
Obtaining/maintaining adequate financing
Regulatory compliance
View Results
Eric Langer Outsourcing Outlook Eric LangerBiopharma Outsourcing Activities Update
Cynthia Challener, PhD Ingredients Insider Cynthia Challener, PhDAppropriate Process Design Critical for Commercial Manufacture of Highly Potent APIs
Jill Wechsler Regulatory Watch Jill Wechsler FDA and Manufacturers Seek a More Secure Drug Supply Chain
Sean Milmo European Regulatory WatchSean MilmoQuality by Design?Bridging the Gap between Concept and Implementation
Report: Pfizer Makes $101 Billion Offer to AstraZeneca
Medicare Payment Data Raises Questions About Drug Costs
FDA Wants You!
A New Strategy to Tackle Antibiotic Resistance
Drug-Diagnostic Development Stymied by Payer Concerns
Source: ePT--the Electronic Newsletter of Pharmaceutical Technology,
Click here