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.

US dietary supplement industry stakeholders are split on the Food and Drug Administration requiring product registration as a draft Senate bill would authorize, but agreement is likely on a provision ordering the agency to publish a final guidance on new dietary ingredient notifications.

Health, Education, Labor and Pensions Committee Chairwoman Patty Murray, D-WA, and ranking member Richard Burr, R-NC, included the supplement registration...