FDA Launches New Portal for Product Questions, Meeting Requests

March 14, 2019

The FDA launched an online portal that allows caregivers, advocacy groups and individual patients to request meetings or clarifications on drugs, biologics or combination products.

The portal will direct all questions to the corresponding center or office and aims to improve understanding of the agency’s regulatory efforts.

The portal, which is not intended for use by industry stakeholders, includes a “request to connect” page through which users can identify their user category, whether they have a question or a meeting request, and the product type in question.

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