The 2024 New Drug Therapy Approvals report is designed to showcase CDER’s role in bringing safe and effective drugs to market for patients and consumers.
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 …
Nanotechnology Guidance Documents | FDA
FDA has issued several guidance documents on topics relating to the application of nanotechnology in FDA-related products.
Novel Drug Approvals for 2024 | FDA
Jul 14, 2025 · CDER’s novel drug approvals for 2024 are listed below. For more information, download the report. The table below is a list of CDER’s novel drugs approvals for 2024.
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 ...
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 …
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.
In early 2024, our Office played a pivotal role in establishing the Center for Drug Evaluation and Research (CDER) Quantitative Medicine Center of Excellence (QM CoE), an alliance of several …
FDA grants accelerated approval to zenocutuzumab-zbco
On December 4, 2024, the FDA granted accelerated approval to zenocutuzumab-zbco for non-small cell lung cancer and pancreatic adenocarcinoma.
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.