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"The posting of both rules on the [White House's Office of Management and Budget] website means they have reached the final step of review for regulatory documents." The proposed ban has faced worries from critics who say it could lead to heightened border problems with Mexican drug cartels saturating the U.S

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Summary To summarize: FDA is asking applicants to undertake high-cost, resource-intensive trials and to endure long delays to market access, without providing clear design guidance or success criteria

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