Drug Safety, Medical Device, And Laboratory Regulation
US Congress 116th Congress
Addiction Prevention and Responsible Opioid Practices Act [HB-7701]
To establish programs related to prevention of prescription opioid misuse, and for other purposes.
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Addiction Prevention and Responsible Opioid Practices Act [S.4242]
A bill to establish programs related to prevention of prescription opioid misuse, and for other purposes.
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US Congress 116th Congress
Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act, 2021 [HB-7610]
Provides FY2021 appropriations for the Department of Agriculture (USDA), the Food and Drug Administration, and related agencies. The bill provides appropriations to USDA for Agricultural Programs, including the Office of the Secretary, Executive Operations, the Economic Research Service, the National Agricultural Statistics Service, the Agricultural Research Service, the National Institute of Food and Agriculture, the Animal and Plant Health Inspection Service, the Agricultural Marketing Service, and the Food Safety and Inspection Service. The bill
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MMEDS Act of 2020 Medical Manufacturing, Economic Development, and Sustainability Act of 2020 [HB-7527]
To rescue domestic medical manufacturing activity by providing incentives in economically distressed areas of the United States and its possessions.
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Safer Compounding in Hospitals Act of 2020 [HB-7518]
Temporarily provides an additional payment under Medicare to hospitals that use a specified automated technology to prepare sterile intravenous treatments.
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Infectious Disease Epidemic and Pandemic Preparedness Act [HB-7531]
To direct the Secretary of Health and Human Services to increase Federal efforts to prepare for and respond to public health emergencies with respect to the spread of infectious diseases, and for other purposes.
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Helping Experts Accelerate Rare Treatments Act of 2020 [HB-7567]
To amend the Federal Food, Drug, and Cosmetic Act to improve the treatment of rare diseases and conditions, and for other purposes.
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Prescription Drug Pricing Reduction Act of 2020 [S.4199]
Alters several programs and requirements relating to the prices of prescription drugs under Medicare and Medicaid. Among other things, the bill requires drug manufacturers to issue rebates to the Centers for Medicare & Medicaid Services (CMS) for certain drugs covered under Medicare for which the average manufacturer price increases faster than inflation; requires drug manufacturers to issue rebates to the CMS for discarded amounts of certain single-dose drugs covered under Medicare, based on information reported by providers; reduces the annual
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Taxpayer Research and Coronavirus Knowledge Act of 2020 [HB-7288]
To direct the Secretary of Health and Human Services and other Federal officials to compile into a searchable database information relating to Federal support for biomedical research and development related to COVID-19, and for other purposes.
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MMAPPP Act of 2020 Make Medications Affordable by Preventing Pandemic Price gouging Act of 2020 [HB-7296]
Imposes licensing and price restrictions on federally supported drugs and other medicines intended to address COVID-19 (i.e., coronavirus disease 2019) or other public health emergencies. With respect to a COVID-19 drug patent developed using certain types of federal support, any license granted by the federal government shall be open and nonexclusive. Similarly, a licensee or assignee for such a patent shall grant open nonexclusive licenses for the patent. An entity that receives a license shall pay reasonable royalties to (1) the patent holder,
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Promising Pathway Act [HB-7269]
To amend the Federal Food, Drug, and Cosmetic Act to establish a time-limited provisional approval pathway, subject to specific obligations, for certain drugs and biological products, and for other purposes.
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Pandemic Anti-Monopoly Act [S.4013]
Places a moratorium on certain mergers and acquisitions during the COVID-19 (i.e., coronavirus disease 2019) pandemic. Specifically, the bill prohibits certain transactions such as acquisitions (1) by firms with over $100 million in revenue; (2) by financial institutions or equity funds with over $100 million in capitalization; and (3) involving firms with exclusive patents pertaining to COVID-19 pandemic-related production, manufacturing, distribution, or infrastructure. However, a waiver may be granted if the participating firms demonstrate that
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Creating Hope Reauthorization Act [S.4010]
A bill to amend the Federal Food, Drug, and Cosmetic Act to make permanent the authority of the Secretary of Health and Human Services to issue priority review vouchers to encourage treatments for rare pediatric diseases.
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Hand Sanitizer Guidance Extension Act of 2020 [S.3938]
Specifies that certain Food and Drug Administration guidance related to the manufacture of alcohol-based hand sanitizers during the COVID-19 (i.e., coronavirus disease 2019) public health emergency shall remain in effect for two years after this bill's enactment. The bill also imposes various requirements related to the content of hand sanitizers manufactured while the guidance is in effect.
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Ensuring Patient Access to Critical Breakthrough Products Act of 2020 [S.3914]
Provides for Medicare coverage of medical devices that are approved under the Food and Drug Administration (FDA) Breakthrough Devices Program. (Under the program, manufacturers work with the FDA to expedite the review and approval of certain medical devices that provide for more effective treatment or diagnosis of life-threatening or irreversibly debilitating human diseases or conditions.) The bill allows designated medical breakthrough devices to be temporarily covered under Medicare during a three-year transitional period. The Centers for Medicare
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COVID–19 Emergency Manufacturing Act of 2020 [HB-7113]
To amend the Public Health Service Act to establish an Emergency Office of Manufacturing for Public Health, and for other purposes.
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Promising Pathway Act [S.3872]
Establishes a provisional approval pathway for medicines intended for serious or life-threatening diseases, including illnesses posing a threat of epidemic or pandemic. The period of the provisional approval is for two years and is potentially renewable. The Food and Drug Administration (FDA) must establish a priority review system to evaluate completed provisional approval applications within 90 days of receipt. A provisional approval application may be approved if the FDA determines that (1) there is substantial evidence of safety for the drug;
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Accelerating Access to Critical Therapies for ALS Act [HB-7071]
Establishes a grant program, as well as a new center within the Food and Drug Administration (FDA), to facilitate access to investigational therapies for neurodegenerative diseases such as amyotrophic lateral sclerosis (i.e., ALS, also known as Lou Gehrig's disease, a progressive and fatal disease). Specifically, the Department of Health and Human Services (HHS) must award grants for the provision of investigational drugs for ALS and other rapidly progressing neurodegenerative diseases through an expanded access (i.e., compassionate use) program.
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COVID–19 Emergency Manufacturing Act of 2020 [S.3847]
A bill to amend the Public Health Service Act to establish an Emergency Office of Manufacturing for Public Health, and for other purposes.
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Good Samaritan Menstrual Products Act [HB-7054]
Limits civil and criminal liability for manufacturers, distributors, nonprofit organizations, and other persons regarding good faith donations of apparently usable menstrual products. Specifically, persons may only be liable if their actions constitute gross negligence or intentional misconduct and result in injury to or death of a user or recipient of those products.