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FDA issues two drafts to gather feedback from stakeholders before finalizing a new regulation or guideline.
Any company or individual who falls under the jurisdiction of the FDA and is affected by the draft regulations.
The drafts can typically be filled out online on the FDA's official website or through a designated submission portal.
The purpose is to gather comments, feedback, and suggestions from stakeholders to ensure that the final regulation is effective and feasible.
Information such as the impact on public health, costs and benefits of the regulation, and potential alternatives must be reported.
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