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September 20, 2023
Leaders at CDER and CBER give update on organizational changes at FDA.
September 19, 2023
The agency’s work with EUnetHTA 21 helped it to prepare the EU for implementation of the regulation.
Anemia, experienced by most myelofibrosis patients, has caused over 30% of patients to discontinue their treatment.
Iopofosine provides targeted delivery of idodine-131 directly to cancer cells.
September 18, 2023
Kelley Burridge, PhD, Product Quality Team Leader, OBP, OPQ, CDER, U.S. FDA, discusses the barriers to the development of continuous manufacturing processes after implementing ICH Q13.
The draft guidance document discusses the development of labeling for proposed biosimilars and interchangeable biosimilars for submission under section 351(k) of the Public Health Service Act.
September 15, 2023
The safety profile of erdafitinib observed in THOR was consistent with the previously reported safety profile of erdafitinib in metastatic urothelial carcinoma (mUC).
September 08, 2023
The new policy will require trading partners to supply, accept, and manage all documentation of product and ownership of prescription drugs electronically.
September 03, 2023
FDA is anticipating how AI may advance manufacturing and improve supply chain security.
September 02, 2023
The ACT EU initiative aims to develop the European Union further as a competitive centre for innovative clinical research.