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Sponsors are assessed BPD fees when they enter the initial product development program. They also must pay an annual BDP fee at the beginning of each fiscal year as long as the product remains in active development. Read More
The agency defines a therapeutic radiopharmaceutical as any product that contains a radionuclide and is used in patients with cancer for treatment of the disease or for palliation of tumor-related symptoms such as pain. Read More
CDER launched two new efforts to gather feedback about the use of quality metrics in modernizing drug quality systems, calling for participants in a voluntary pilot program and encouraging meeting requests. Read More
Labeling for oncology radiopharmaceuticals must include information on the potential for genotoxicity and adverse reproductive toxicity, the FDA said in new draft guidance. Read More
The FDA released guidance on the agency’s BsUFA II fee structure Thursday finalizing the changes introduced since BsUFA I — including that biosimilars will no longer be assessed supplemental or establishment fees and the number of program fees per year will be limited to five per company. Read More
The “tangled web” of drug supply and payment chains benefits all the players except consumers, according to a Senate Finance Committee minority report. Read More