Drug Safety, Medical Device, And Laboratory Regulation
US Congress 116th Congress
Safeguarding Therapeutics Act [HB-5663]
To amend the Federal Food, Drug, and Cosmetic Act to give authority to the Secretary of Health and Human Services, acting through the Commissioner of Food and Drugs, to destroy counterfeit devices.
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FDA Accountability for Public Safety Act [HB-5632]
To establish procedures regarding the approval of opioid drugs by the Food and Drug Administration.
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To amend the Federal Food, Drug, and Cosmetic Act with respect to the regulation of hemp-derived cannabidiol and hemp-derived cannabidiol containing substances. [HB-5587]
To amend the Federal Food, Drug, and Cosmetic Act with respect to the regulation of hemp-derived cannabidiol and hemp-derived cannabidiol containing substances.
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Recall Unsafe Drugs Act of 2020 [HB-5578]
To provide for the mandatory recall of drugs regulated by the Food and Drug Administration.
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Reversing the Youth Tobacco Epidemic Act of 2020 [S.3174]
Revises requirements related to the safety, sale, and advertisement of tobacco products, including electronic nicotine delivery systems (e.g., e-cigarettes, e-hookah, e-cigars, and vape pens). Among other requirements, the bill requires the Food and Drug Administration (FDA) to implement regulations to require color graphics on the labeling of cigarette packages, depicting the negative health consequences of smoking; requires the FDA to apply regulations on tobacco products to all tobacco products, including e-cigarettes; prohibits the retail online
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Responsibility in Drug Advertising Act of 2020 [S.3180]
A bill to amend the Federal Food, Drug, and Cosmetic Act to restrict direct-to-consumer drug advertising.
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Affordable Drug Manufacturing Act of 2020 [S.3162]
A bill to amend the Public Health Service Act to establish an Office of Drug Manufacturing.
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Medical Innovation Act of 2020 [S.3163]
Requires certain drug manufacturers to make payments to fund research supported by the Food and Drug Administration (FDA) and the National Institutes of Health (NIH). A drug manufacturer with over $1 billion in net income in a fiscal year that has entered into a relevant settlement agreement regarding specified violations must pay 0.75%-1.5% of its net income to the Department of Health and Human Services for each of its covered blockbuster drugs. A covered blockbuster drug is a drug that has at least $1 billion in net sales in a year and was developed,
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National Biomedical Research Act [S.3161]
A bill to establish the "Biomedical Innovation Fund", and for other purposes.
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Conditional Approval Act [HB-5497]
To amend the Federal Food, Drug, and Cosmetic Act to establish a time-limited conditional approval pathway, subject to specific obligations, for certain drugs, and for other purposes.
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Affordable Drug Manufacturing Act of 2019 [HB-5501]
To amend the Public Health Service Act to establish an Office of Drug Manufacturing.
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US Congress 116th Congress
Conditional Approval Act [S.3133]
A bill to amend the Federal Food, Drug, and Cosmetic Act to establish a time-limited conditional approval pathway, subject to specific obligations, for certain drugs, and for other purposes.
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US Congress 116th Congress
Ally’s Act [HB-5485]
To amend title XXVII of the Public Health Service Act and the Patient Protection and Affordable Care Act to require coverage of hearing devices and systems in certain private health insurance plans, and for other purposes.
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ALS Placebo No More Act [HB-5480]
Requires the Food and Drug Administration and the National Institutes of Health to collaborate to provide all patients with ALS (amyotrophic lateral sclerosis, also referred to as Lou Gehrig's disease) with access to medicines in clinical trials.
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PREVENT Act of 2020 Providing Resources to End the Vaping Epidemic Now for Teenagers Act of 2020 [S.3096]
A bill to amend the Public Health Service Act to authorize the Director of the Centers for Disease Control Prevention to develop a program to prevent the use of electronic nicotine delivery systems among students in middle and high schools, to award grants to State and local health agencies to implement such program, and for other purposes.
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PREVENT Act of 2020 Providing Resources to End the Vaping Epidemic Now for Teenagers Act of 2020 [HB-5482]
To amend the Public Health Service Act to authorize the Director of the Centers for Disease Control and Prevention to develop a program to prevent the use of electronic nicotine delivery systems among students in middle and high schools, to award grants to State and local health agencies to implement such program, and for other purposes.
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Lower Insulin Costs Now Act [HB-5444]
To amend the Biologics Price Competition and Innovation Act of 2009 to streamline the transition of certain products from approval as a drug to licensure as a biological product, and for other purposes.
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US Congress 116th Congress
LAB Act Laboratory Access for Beneficiaries Act [S.3049]
Revises the periods during which laboratories must report clinical diagnostic test information to the Centers for Medicare & Medicaid Services for purposes of determining Medicare payment rates. Additionally, the Medicare Payment Advisory Commission must evaluate the methodology used to determine a specified laboratory fee schedule.
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National Biomedical Research Act [HB-5400]
Establishes and makes deposits into the Biomedical Innovation Fund for initiatives at the National Institutes of Health (NIH) and the Food and Drug Administration (FDA) for advancing medical innovation, including by supporting (1) research for disease prevention, diagnosis, and treatment; (2) research for diseases that disproportionally account for federal health care spending; (3) the development, review, and post-market surveillance of medical products; (4) early-career scientists, including researchers from traditionally underrepresented groups;
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Protecting America’s Life Saving Medicines Act of 2019 [HB-5402]
Directs the Food and Drug Administration (FDA) to conduct a study on drugs that are currently being tested and are unlikely to be approved, but would, if approved, address an unmet medical need for the treatment of a serious or life threatening disease or condition or a rare disease or condition (high-risk, high-reward drugs). The FDA must submit to the Department of the Treasury a list of such high-risk, high-reward drugs not later than 180 days after the completion of the study. The bill also allows a new tax credit for 25% of the clinical testing
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