FDA Week - 05/19/2017

Off-label, pediatric research, device servicing, OTC reform plugged . . .

Lawmakers Signal They Want Additional Riders In User Fee Reauthorization

May 18, 2017
House Energy & Commerce health subcommittee lawmakers provided a preview Thursday (May 18) of legislation that could be added to user fee reauthorization either during the full committee markup or when the legislation hits the floor, including bills related to off-label communication, pediatric cancer research, orphan drug exclusivity, regulation of medical device servicers and over-the-counter monograph reform. Committee leadership expects further amendments to be filed when the user fee legislation is heard by the full committee, signaling the agreement is...

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