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Promote the organization of tax reform Americans suggest that the FDA reform PMTA process

Promote the organization of tax reform Americans suggest that the FDA reform PMTA process

2022-11-10

New Consumer Report, November 9th, according to foreign news reports, tax reform Americans (ATR) told Reagan-Yudel Foundation in the letter that the US Food and Drug Administration was serious and seriously failed to fulfill its protection of the public to protect the public. Healthy Congress authorized.


The Reagan-Yuder Foundation is reviewing the policy and procedures of FDA Tobacco Products (CTP), which has previously been criticized for several months of handling electronic cigarette review. As part of its evaluation, the foundation provides the opportunity to share their opinions for stakeholders.


In its comments, ATR recommends seven reforms to improve the performance of the agency:


FDA should introduce interdisciplinary expert analysis to consider input in the fields of psychology and behavioral economics to improve the public's understanding and participation of decision -making process.


As the initial promise, the FDA must provide a simple and streamlined PMTA channel.


The PMTA process of the FDA should focus on product safety and personal risks, rather than better acquisition and crowd evaluation by a single post -listing supervision team.


FDA should regularly and actively contact all PMTA applicants, instead of release MDO after a year of silence.


The FDA should consider implementing product standards to help simplify the process, and treat countries such as Britain as a model for the effective regulatory system.


FDA must take an emergency action to crack down on major public error information that exists in the community and is a smoking quit obstacle.


The FDA must reform its way of dealing with dangerous behaviors of adolescents. FDA should accept teenagers to benefit from reducing harm and correctly evaluate the consequences of reducing the use of electronic cigarettes for adults and adolescents.


ATR's consumer problem head, Tim Andrews, wrote that the review of the Reagan-Yuder Foundation can help the agency improve the PMTA review process.


"The PMTA process has brought the applicant a relatively heavy administrative burden," he said. "When the process and requirements change, the FDA fails to notify the applicant, and it is said that some applicants have adopted new different standards. Fail of the FDA is structural. These problems cannot be solved by increasing funds, especially if they cannot charge user fees from small electronic cigarette manufacturers. "


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