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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
CDER plans to start using a new informatics platform for new drug approvals in October, following the processes already in place for generic drug reviews, says CDER Director Janet Woodcock. Read More