Pfizer Inc. announced it has received a Complete Response Letter from FDA in response to the Biologics License Application for the company’s proposed trastuzumab biosimilar. In the CRL, FDA highlighted the need for additional technical information.
The additional requested information does not relate to safety or clinical data submitted in the application, the company said. Pfizer said it’s working closely with FDA to address the contents of the letter.
By law, the Food and Drug Administration is required to determine whether a drug, device, biologic, or medical device is “safe and effective.” But the FDA determination does not control whether the Centers for Medicare & Medicaid Services will pay for it. To satisfy CMS, medical products and services must be “reasonable and necessary,” meaning...
As a radiation oncologist, I am struck by how often the decisive variable in lung cancer is not the sophistication of our therapy, but the timing of our encounter with the disease. The American Cancer Society projects 618,120 cancer deaths in the United States in 2025, with lung cancer remaining as the single largest contributor,...
