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From 2003 to 2023, 943 drugs were approved through the 505(b)(2) pathway. As of January 1, 2023, CMS has begun issuing unique J-codes to 505(b)(2) drugs dating back to 2003. “In In 2022, based upon a complaint filed by a pharmaceuticalcompany, CMS was asked to reevaluate the SSA section that establishes the J-code,” Soefje said.
The world’s biggest pharmaceuticalcompany Pfizer announced in June 2008 that it would be putting its “full scope and scale” behind a push into the cancer market. ” “Between 2003 and 2005 global sales for cancer-treating drugs grew by 40%.”
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