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Health Policy and Services Research
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United States.
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Government Regulation
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De Lew, Nancy, author
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Annual status report information and other submissions for postmarketing requirements and commitments: using forms FDA 3988 and FDA 3989 : guidance for industry
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Breakthrough Devices Program: guidance for industry and Food and Drug Administration staff
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CARES Act: experts identified safeguards to help selected HHS agencies protect against potential political interference : report to congressional requesters
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Considerations for the use of real-world data and real-world evidence to support regulatory decision-making for drug and biological products: guidance for industry
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Enhanced drug distribution security at the package level under the Drug Supply Chain Security Act: guidance for industry
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