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Start Over You searched for: Collections Health Policy and Services Research Remove constraint Collections: Health Policy and Services Research Subjects Humans Remove constraint Subjects: Humans Subjects United States. Food and Drug Administration. Remove constraint Subjects: United States. Food and Drug Administration. Publication Year 2019 Remove constraint Publication Year: <span class="single" data-blrl-single="2019">2019</span>

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62. Citizen petitions and petitions for stay of action subject to section 505(q) of the Federal Food, Drug, and Cosmetic Act

63. Wholesale distributor verification requirement for saleable returned drug product: compliance policy

64. Amyotrophic lateral sclerosis: developing drugs for treatment

65. Changes to existing medical software policies resulting from section 3060 of the 21st Century Cures Act: guidance for industry and Food and Drug Administration staff

66. Bacterial risk control strategies for blood collection establishments and transfusion services to enhance the safety and availability of platelets for transfusion

67. Further testing of donations that are reactive on a licensed donor screening test for antibodies to hepatitis C virus

68. Investigational enzyme replacement therapy products: nonclinical assessment

69. Investigational in vitro diagnostics in oncology trials: streamlined submission process for study risk determination

70. Prescription Drug User Fee Act waivers, reductions, and refunds for drug and biological products