INTRODUCTION Nanotechnology can be used in a broad array of FDA-regulated products, such as human drug products, including those that are biological products.3 Nanotechnology may be used to …
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 cosmetics to ...
Nanotechnology | FDA
Nanotechnology Research at NCTR Nanotechnology, the manipulation of material at nanoscale dimensions is a challenging scientific area where specific tools are needed to characterize and …
Quality Considerations and Control for Drug Products Containing Nanomaterials From Doxil to Onpattro
Approved Drug Products with Therapeutic Equivalence Evaluations ...
Dec 12, 2025 · FDA’s Approved Drug Products with Therapeutic Equivalence Evaluations (Orange Book) identifies drug products approved on the basis of safety and effectiveness.
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 approvals ...
Novel Drug Approvals for 2024 | FDA
Jul 14, 2025 · What are "Novel" Drugs? "Novel" drugs are new drugs never before approved or marketed in the U.S. See Drugs@FDA for information about all of CDER’s approved drugs and …
FDA Purplebook
FDA Purplebook ... FDA Purplebook