Drug Safety, Medical Device, And Laboratory Regulation
US Congress 116th Congress
Reaffirming support of fundamental United States principles at the United Nations and encouraging the World Health Organization to embrace technological advancements in tobacco control. [HR-896]
This resolution directs the Department of State and the Department of Health and Human Services to encourage the United Nations and the World Health Organization to adopt policies to advance technology and innovation that can reduce the burden of death and disease caused from cigarette smoking.
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Securing America’s Medicine Cabinet Act of 2020 [S.3432]
A bill to support the advanced manufacturing technologies program of the Food and Drug Administration, to establish National Centers of Excellence in Advanced Pharmaceutical Manufacturing, and for other purposes.
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US Congress 116th Congress
VALID Act of 2020 Verifying Accurate Leading-edge IVCT Development Act of 2020 [S.3404]
A bill to amend the Federal Food, Drug, and Cosmetic Act to provide for the regulation of in vitro clinical tests, and for other purposes.
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VALID Act of 2020 Verifying Accurate Leading-edge IVCT Development Act of 2020 [HB-6102]
To amend the Federal Food, Drug, and Cosmetic Act to provide for the regulation of in vitro clinical tests, and for other purposes.
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US Congress 116th Congress
BENEFIT Act of 2020 Better Empowerment Now to Enhance Framework and Improve Treatments Act of 2020 [S.3385]
A bill to strengthen the use of patient-experience data within the benefit-risk framework for approval of new drugs.
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US Congress 116th Congress
Medical Supply Chain Security Act [HB-6049]
To amend the Federal Food, Drug, and Cosmetic Act to provide enhanced security for the medical supply chain.
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US Congress 116th Congress
Cure the Coronavirus Act [HB-6019]
Expands the tropical disease priority review voucher program to include COVID-19 (a respiratory disease caused by a novel coronavirus), thereby providing manufacturers with incentives for development of a vaccine.
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Environmental Justice For All Act [HB-5986]
Establishes several environmental justice requirements, advisory bodies, and programs to address the disproportionate adverse human health or environmental effects of federal laws or programs on communities of color, low-income communities, or tribal and indigenous communities. Specifically, the bill prohibits disparate impacts on the basis of race, color, or national origin as discrimination. Aggrieved persons may seek legal remedy when faced with such discrimination. In addition, the bill directs agencies to follow certain requirements concerning
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US Congress 116th Congress
Medical Supply Chain Security Act [S.3343]
A bill to amend the Federal Food, Drug, and Cosmetic Act to provide enhanced security for the medical supply chain.
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Zero Tolerance for Deceptive Fentanyl Trafficking Act [S.3342]
A bill to amend the Controlled Substances Act to prohibit the deceptive sale of fentanyl, and for other purposes.
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Safe Medicine Act [HB-5982]
To direct the Secretary of Health and Human Services to study American dependence on Chinese pharmaceuticals and to empower the Food and Drug Administration to issue boxed warnings in the case of critical contamination.
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US Congress 116th Congress
Restore and Modernize Our National Labs Act [HB-5966]
Provides funding to the Department of Energy (DOE) for deferred maintenance, critical infrastructure needs, and modernization of National Laboratories. DOE shall submit, with the annual budget submission of the President through FY2025, a list of projects for which DOE will provide funding under this bill.
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Safe Medicine Act [HB-5927]
To direct the Secretary of Health and Human Services to study American dependence on unsafe Chinese pharmaceuticals and to empower the Food and Drug Administration to mandate drug recalls in the case of critical contamination.
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Foreign Manufacturers Legal Accountability Act of 2019 [HB-3737]
To require foreign manufacturers of products imported into the United States to establish registered agents in the United States who are authorized to accept service of process against such manufacturers.
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Transparency in Prescription Drug Advertising Act [HB-5894]
Requires that the list prices of drugs be included, as appropriate, in advertising for such drugs and directs the Department of Health and Human Services to issue department-wide guidance to that effect that is consistent with regulations issued by the Centers for Medicare & Medicaid Services (CMS) regarding drug price transparency. On May 10, 2019, the CMS issued a final rule titled Medicare and Medicaid Programs; Regulation to Require Drug Pricing Transparency. The rule requires direct-to-consumer television advertisements for drugs and biologics
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US Congress 116th Congress
To amend title XIX of the Social Security Act to provide States with the option under the Medicaid program to pay for covered outpatient drugs through risk-sharing value-based agreements, and for other purposes. [HB-5882]
Allows state Medicaid programs to pay for certain gene therapy drugs through risk-sharing value-based payment agreements with drug manufacturers. The bill applies to covered outpatient drugs that provide potentially curative treatment for serious or life-threatening rare diseases or conditions after not more than three administrations.
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Fairness in Orphan Drug Exclusivity Act [S.3271]
A bill to amend the Federal Food, Drug, and Cosmetic Act with respect to limitations on exclusive approval or licensure of orphan drugs, and for other purposes.
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US Congress 116th Congress
Veterans HOPE Act Veterans Heroin Overdose Prevention Examination Act [HB-5774]
Requires the Department of Veterans Affairs (VA) to complete a review of the deaths of all covered veterans who died from opioid overdoses during the five-year period preceding the enactment of this bill. Covered veterans are those who received VA hospital care or medical services during the five-year period preceding the death of the veteran. The VA shall report on the results of the review and make such report publicly available.
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MODERN Labeling Act of 2020 Making Objective Drug Evidence Revisions for New Labeling Act of 2020 [HB-5668]
To amend the Federal Food, Drug, and Cosmetic Act to modernize the labeling of certain generic drugs, and for other purposes.
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Responsibility in Drug Advertising Act of 2019 [HB-4106]
To amend the Federal Food, Drug, and Cosmetic Act to restrict direct-to-consumer drug advertising.