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The 505(b)(2) approval pathway, designed to expedite reviews, actually takes about five months longer than the standard NDA process, says a new report from the Tufts Center for the Study of Drug Development. Read More
The Drug Controller General of India asked manufacturers twice last year to submit Phase IV trial protocols— once in June and again in September — but most drugmakers have still not fulfilled the regulatory requirement. Read More
Two senior Democratic congressmen met with President Donald Trump and discussed a bill granting Medicare the ability to negotiate drug prices, which they plan to introduce in the House within the next two weeks. Read More