Cefuroxime – Injection products
Cefuroxime – Injection products; Exception to the recognized standard of CLSI M100
Meropenem – Injection products
Meropenem – Injection products
Levofloxacin Oral, Injection products
Levofloxacin Oral, Injection products
Minocycline Oral, Injection products
Minocycline Oral, Injection products
Moxifloxacin Oral, Injection Products
Moxifloxacin Oral, Injection products: Additional FDA-identified interpretive criteria
Tetracycline – Oral products
Tetracycline – Oral products
Increasing Options in Clinical Research to Facilitate Medical Product Development
FDA issued a final rule to help advance medical product development without compromising the rights, safety and welfare of people…
Realizing the Promise of Real-World Evidence
Realizing the full potential of RWE in regulatory decision-making presents several challenges, and work is underway at the FDA to…
FDA approves brentuximab vedotin with lenalidomide and rituximab for relapsed or refractory large B-cell lymphoma
On February 11, 2025, the Food and Drug Administration approved brentuximab vedotin (Adcetris, Seagen Inc., a subsidiary of Pfizer) in…
CDER’s Framework for Regulatory Advanced Manufacturing Evaluation (FRAME) Initiative
CDER’s Framework for Regulatory Advanced Manufacturing Evaluation (FRAME) Initiative