Drug Safety, Medical Device, And Laboratory Regulation
US Congress 116th Congress
Allowing Greater Access to Safe and Effective Contraception Act [S.930]
Permits health savings accounts, medical savings accounts, and employer reimbursements for medications to be used for over-the-counter drugs. The bill also removes the limit on employee contributions to flexible spending accounts offered under specified health plans established pursuant to a pretax salary reduction agreement with an employer (i.e., cafeteria plans). Further, the bill requires the Food and Drug Administration to give priority review, at no cost, to applications for modifications to already-approved contraceptive drugs that are intended
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Henrietta Lacks Enhancing Cancer Research Act of 2019 [HB-1966]
Requires the Government Accountability Office to complete a study reviewing how federal agencies address barriers to participation in federally-funded cancer clinical trials by individuals from underrepresented populations and provide recommendations for addressing such barriers.
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Henrietta Lacks Enhancing Cancer Research Act of 2019 [S.946]
Requires the Government Accountability Office to complete a study reviewing how federal agencies address barriers to participation in federally-funded cancer clinical trials by individuals from underrepresented populations and provide recommendations for addressing such barriers.
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Traditional Cigar Manufacturing and Small Business Jobs Preservation Act of 2019 [HB-1854]
Exempts traditional large and premium cigars from regulation by the Food and Drug Administration (FDA) and from user fees assessed on tobacco products by the FDA.
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ALERT Act of 2019 Analyzing and Leveraging Existing Rx Transactions Act of 2019 [HB-1845]
Requires the Food and Drug Administration to establish an electronic system to provide pharmacists with a patient's prescription and dispensing history with respect to covered drugs (i.e., those identified as having a risk of misuse or abuse).
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Affirming the importance of the Orphan Drug Act, celebrating the over 750 new orphan therapies approved since its creation, and recognizing the need to continue supporting research and development for rare diseases. [HR-242]
This resolution applauds the growth in research and development into new therapies for rare diseases and recognizes that significant research and development efforts and related investments are needed to develop therapies to treat and cure thousands of rare diseases for which no treatment options are currently available.
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Horseracing Integrity and Safety Act of 2020 [HB-1754]
Recognizes the Horseracing Integrity and Safety Authority for purposes of developing and implementing a horseracing anti-doping and medication control program and a racetrack safety program. The authority shall establish an anti-doping and medication control standing committee and a racetrack safety standing committee to provide guidance to the authority on the development and maintenance of the programs. The Federal Trade Commission (FTC) shall have oversight over the authority. The authority shall submit to the FTC any proposed rule, standard,
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Short on Competition Act [S.844]
A bill to allow for expedited approval of generic prescription drugs and temporary importation of prescription drugs in the case of marginally competitive drug markets and drug shortages.
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Personal Care Products Safety Act [S.726]
A bill to amend the Federal Food, Drug, and Cosmetic Act to ensure the safety of cosmetics.
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Marijuana Data Collection Act [HB-1587]
Requires the Department of Health and Human Services, in coordination with the Department of Justice, the Department of Labor, and relevant state agencies, to enter into an arrangement with the National Academy of Sciences in order to study the effects of marijuana legalization in states for medicinal or non-medicinal use.
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SAFE Kids Act Stopping Appealing Flavors in E-Cigarettes for Kids Act [S.655]
A bill to impose additional restrictions on tobacco flavors for use in e-cigarettes.
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Orange Book Transparency Act of 2019 [HB-1503]
To amend the Federal Food, Drug, and Cosmetic Act regarding the list under section 505(j)(7) of the Federal Food, Drug, and Cosmetic Act, and for other purposes.
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Efficiency and Transparency in Petitions Act [S.660]
A bill to address abuse of the Food and Drug Administration's citizen petition process by brand drug manufacturers.
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Purple Book Continuity Act of 2019 [HB-1520]
Provides continuing FY2021 appropriations to federal agencies through December 28, 2020. It is known as a continuing resolution (CR) and prevents a government shutdown that would otherwise occur if the FY2021 appropriations bills have not been enacted when the existing CR expires on December 21, 2020.
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FAIR Generics Act Fair And Immediate Release of Generic Drugs Act [HB-1506]
To amend the Federal Food, Drug, and Cosmetic Act to ensure that valid generic drugs may enter the market.
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SAFE Kids Act Stopping Appealing Flavors in E-Cigarettes for Kids Act [HB-1498]
To impose additional restrictions on tobacco flavors for use in e-cigarettes.
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ADAPT Act Accelerated Drug Approval for Prescription Therapies Act [S.658]
A bill to provide for an accelerated approval pathway for certain drugs that are authorized to be lawfully marketed in other countries.
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Affordable Insulin Act of 2019 [HB-1478]
To amend the Federal Food, Drug, and Cosmetic Act to allow for the importation of affordable and safe insulin by wholesale distributors, pharmacies, and individuals.
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E-Cigarette Youth Protection Act [S.616]
A bill to impose user fees on manufacturers and importers of electronic nicotine delivery systems.
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Medicare for All Act of 2019 [HB-1384]
Establishes a national health insurance program that is administered by the Department of Health and Human Services (HHS). Among other requirements, the program must (1) cover all U.S. residents; (2) provide for automatic enrollment of individuals upon birth or residency in the United States; and (3) cover items and services that are medically necessary or appropriate to maintain health or to diagnose, treat, or rehabilitate a health condition, including hospital services, prescription drugs, mental health and substance abuse treatment, dental and
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