Principles for Regulation and Oversight of Emerging Technologies, March 2011; available online at:...
Nanotechnology Guidance Documents | FDA
FDA has issued several guidance documents on topics relating to the application of nanotechnology in FDA-related products.
Drug Products, Including Biological Products, that Contain ...
Current thinking for development of human drug products, including those that are biological products, where nanomaterials are present in finished dosage form.
FDA’s Approach to Regulation of Nanotechnology Products
Nanotechnology Guidance Documents Nanotechnology Fact Sheet As a public health agency using scientific information to make regulatory decisions about products ranging from …
Considering Whether an FDA-Regulated Product Involves the Application ...
GUIDANCE DOCUMENT Considering Whether an FDA-Regulated Product Involves the Application of Nanotechnology Guidance for Industry June 2014
Novel Drug Approvals for 2024 | FDA
Jul 14, 2025 · Novel Drug Approvals for 2024 Advancing Health Through Innovation: New Drug Therapy Approvals 2024 (PDF - 10 MB)
Premarket Approval (PMA) - Food and Drug Administration
5 days ago · Premarket approval (PMA) is the FDA process of scientific and regulatory review to evaluate the safety and effectiveness of Class III medical devices. Class III devices are those …
Oversight-of-Emerging-Technologies-new.pdf. 6 Office of Science and Technology Policy, Office of Management and Budget, and the United States Trade Representative.
This report describes CDER’s 2024 notable drug approvals, which are actions we consider likely to have a significant impact on patient care and public health. These include novel drug …
Nanotechnology Task Force Report 2007 | FDA
Printer-Friendly PDF (287 KB) ... Thank you for submitting to me the Nanotechnology Task Force Report. Nanotechnology holds great promise for the development of new treatments and …