Drug Safety, Medical Device, And Laboratory Regulation
US Congress 114th Congress
CREATES Act of 2016 Creating and Restoring Equal Access to Equivalent Samples Act of 2016 [S.3056]
CREATES Act of 2016 Creating and Restoring Equal Access to Equivalent Samples Act of 2016
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Department of Homeland Security Appropriations Act, 2017 [S.3001]
Department of Homeland Security Appropriations Act, 2017 Provides FY2017 appropriations for the Department of Homeland Security (DHS). TITLE I--DEPARTMENTAL MANAGEMENT AND OPERATIONS Provides appropriations for: the Office of the Secretary and Executive Management, the Office of the Under Secretary for Management, the Office of the Chief Financial Officer, the Office of the Chief Information Officer, Analysis and Operations, and the Office of Inspector General. Requires DHS to: (1) submit to Congress a report on visa overstay data by country as
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Ensuring Patient Access to Critical Breakthrough Products Act of 2016 [S.2998]
Ensuring Patient Access to Critical Breakthrough Products Act of 2016 This bill amends titles XVIII (Medicare) and XIX (Medicaid) of the Social Security Act to modify provisions related to coverage and payment for certain breakthrough medical devices under the Medicare and Medicaid programs. Specifically, with respect to such devices, the bill: (1) provides for transitional coverage; (2) establishes accelerated processes for determining regular coverage and payment; and (3) modifies provisions related to specified payment adjustments, cost thresholds,
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DXM Abuse Prevention Act of 2016 [S.2994]
DXM Abuse Prevention Act of 2016 This bill amends the Federal Food, Drug, and Cosmetic Act to prohibit the sale of a drug containing dextromethorphan (DXM) to an individual under age 18 unless the individual has a prescription or is actively enrolled in the military. Civil monetary penalties that escalate upon repeated violation are imposed. To possess or receive unfinished DXM, a person must be registered with the Department of Health and Human Services as a producer of a drug or medical device or otherwise allowed to engage in the practice of
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Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act, 2017 [S.2956]
Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act, 2017 Provides FY2017 appropriations to the Department of Agriculture (USDA), the Food and Drug Administration (FDA), and related agencies. TITLE I--AGRICULTURAL PROGRAMS Provides appropriations for the following agricultural programs and services: the Office of the Secretary; Executive Operations; the Office of the Chief Information Officer; the Office of the Chief Financial Officer; the Office of the Assistant Secretary for Civil Rights; the Office
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Veterans First Act [S.2921]
Veterans First Act
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Trickett Wendler Right to Try Act of 2016 [S.2912]
Trickett Wendler Right to Try Act of 2016 This bill bars the federal government from prohibiting or restricting the production, manufacture, distribution, prescribing, or dispensing of an experimental drug, biological product, or device that is: (1) intended to treat a patient who has been diagnosed with a terminal illness; and (2) authorized by, and in accordance with, state law. The federal government may not restrict the possession or use of such a treatment by a patient certified by a physician as having exhausted all other treatment options.
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Improving Medical Device Innovation Act [S.2737]
Improving Medical Device Innovation Act This bill amends the Federal Food, Drug, and Cosmetic Act to revise provisions related to medical device performance standards, reporting requirements, and classification panels. A person may request that the Food and Drug Administration (FDA) recognize a performance standard established by a recognized standards organization as a standard to which a medical device may conform in order to meet an FDA requirement. When a request to recognize a standard is received, the FDA must determine whether to recognize
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FDA and NIH Workforce Authorities Modernization Act [S.2700]
FDA and NIH Workforce Authorities Modernization Act This bill amends the Public Health Service Act to revise the Silvio O. Conte Senior Biomedical Research Service to: (1) remove the limit on the number of members, (2) expand eligibility for appointment, (3) set a maximum pay rate, and (4) remove the option for members to contribute to the retirement system of an institution of higher education. The Government Accountability Office (GAO) must report on these amendments. This bill amends the Federal Food, Drug, and Cosmetic Act to grant the Food
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REGROW Act Reliable and Effective Growth for Regenerative Health Options that Improve Wellness [S.2689]
REGROW Act Reliable and Effective Growth for Regenerative Health Options that Improve Wellness This bill amends the Public Health Service Act to require the Food and Drug Administration (FDA) to conditionally approve certain cellular therapeutic products without initiation of large-scale clinical trials. A conditionally approved cellular therapy may be marketed if certain conditions are met, including conditions on the source, processing, and function of the cells in the product.
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Mental Health Reform Act of 2016 [S.2680]
Mental Health Reform Act of 2016
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National Biomedical Research Act [S.2624]
National Biomedical Research Act
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Increasing Competition in Pharmaceuticals Act [S.2615]
Increasing Competition in Pharmaceuticals Act This bill amends the Federal Food, Drug, and Cosmetic Act to revise provisions regarding review and approval of generic drug applications or supplements to generic drug applications for drugs: (1) for which there is a shortage, or (2) that have not been recently introduced to the market by more than one manufacturer and for which tentative approval has not been granted to more than two applications. The Food and Drug Administration (FDA) must prioritize the review of such submissions and act on them
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Changing the Culture of the FDA Act [S.2543]
Changing the Culture of the FDA Act This bill requires the Food and Drug Administration to amend its mission statement to take responsibility for protecting the public health by considering the danger of addiction and overdose death when approving and regulating prescription opioid medications. (Opioid medications are drugs with effects similar to opium, such as certain pain medications.)
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Adding Zika Virus to the FDA Priority Review Voucher Program Act [S.2512]
Adding Zika Virus to the FDA Priority Review Voucher Program Act (Sec. 2) This bill amends the Federal Food, Drug, and Cosmetic Act to add Zika virus disease to the list of tropical diseases under the priority review voucher program, which awards a voucher to the sponsor of a new drug or biological product that is approved to prevent or treat a tropical disease. (A voucher entitles the holder to have a future new drug or biological product application acted upon by the Food and Drug Administration within six months.) The bill makes a technical correction
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Preventing Superbugs and Protecting Patients Act [S.2503]
Preventing Superbugs and Protecting Patients Act (Sec. 2) This bill amends the Federal Food, Drug, and Cosmetic Act to require the Food and Drug Administration (FDA) to identify types of medical devices for which premarket notification must include proposed labeling, including validated instructions regarding cleaning, disinfection, and sterilization. (Sec. 3) The FDA must issue final guidance regarding when a premarket notification is required for a modification to a medical device.
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Advancing Standards in Regenerative Medicine Act [S.2443]
Advancing Standards in Regenerative Medicine Act This bill amends the Federal Food, Drug, and Cosmetic Act to require the Food and Drug Administration (FDA) to facilitate the establishment of a public-private Standards Coordinating Body in Regenerative Medicine and Advanced Therapies. The FDA must work with this body to develop standards to support the development and review of regenerative medicine products.
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Reciprocity Ensures Streamlined Use of Lifesaving Treatments Act of 2015 [S.2388]
Reciprocity Ensures Streamlined Use of Lifesaving Treatments Act of 2015 This bill amends the Federal Food, Drug, and Cosmetic Act to establish a reciprocal marketing approval process that allows for the sale of a drug, biological product, or medical device that has not been approved by the Food and Drug Administration (FDA) if the product is approved for sale in another country. For a product to be granted reciprocal marketing approval, the product's sponsor must submit a request to the FDA that demonstrates: (1) the product may be sold in at least
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Biological Implant Tracking and Veteran Safety Act of 2015 [S.2334]
Biological Implant Tracking and Veteran Safety Act of 2015 This bill directs the Department of Veterans Affairs (VA) to: adopt the unique device identification system developed for medical devices by the Food and Drug Administration (FDA), or implement a comparable standard identification system, for identifying biological implants intended for use in VA medical facilities; permit a vendor to use any of the accredited entities identified by the FDA as an issuing agency; implement a compatible system for tracking implants from human donor or animal
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Cody Miller Patient Medication Information Act [S.2214]
Cody Miller Patient Medication Information Act This bill amends the Federal Food, Drug, and Cosmetic Act to direct the Food and Drug Administration (FDA) to regulate the authorship, content, format, and dissemination of patient medication information for prescription drugs. (Patient medication information includes the instructional brochures provided to patients when a prescription is filled.) FDA regulations must require drug patient medication information to be scientifically accurate, to be based on the approved professional labeling, and to
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