NDI Notification Guidance Deadline Included In Senate Draft Bill For FDA User Fee Programs
HELP Committee Chairwoman Patty Murray, and ranking member Richard Burr also include supplement registration requirement in discussion draft for reauthorizing FDA’s user fee programs for prescription, generic and biosimilar drugs and medical devices.
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FDA should protect companies which “do the right thing” by submitting new dietary ingredient notifications, CRN's Steve Mister said during FDLI's annual conference.
Some stakeholders have supported mandatory listing but they join opponents questioning legislation also authorizing FDA to prohibit sales of products compliant with manufacturing and labeling regulations but deficient, incomplete or late with registration information required for the agency.
Proposal “seems driven by a desire to allow FDA to ‘bar the door’ from listing anything that they wish to keep out that doesn’t meet their convenience,” NPA CEO Daniel Fabricant tells Senate HELP Committee.