Drug Safety, Medical Device, And Laboratory Regulation
US Congress 116th Congress
FAST Generics Act of 2019 Fair Access for Safe and Timely Generics Act of 2019 [HB-985]
To amend the Federal Food, Drug, and Cosmetic Act to ensure that eligible product developers have competitive access to approved drugs and licensed biological products, so as to enable eligible product developers to develop and test new products, and for other purposes.
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CREATES Act of 2019 Creating and Restoring Equal Access to Equivalent Samples Act of 2019 [HB-965]
To promote competition in the market for drugs and biological products by facilitating the timely entry of lower-cost generic and biosimilar versions of those drugs and biological products.
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BLOCKING Act of 2019 Bringing Low-cost Options and Competition while Keeping Incentives for New Generics Act of 2019 [HB-938]
To amend the Federal Food, Drug, and Cosmetic Act, with respect to eligibility for approval of a subsequent generic drug, to remove the barrier to that approval posed by the 180-day exclusivity period afforded to a first generic applicant that has not yet received final approval, and for other purposes.
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North American Wetlands Conservation Extension Act [HB-925]
Reauthorizes the North American Wetlands Conservation Act through FY2024.
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DXM Abuse Prevention Act of 2019 [HB-863]
To amend the Federal Food, Drug, and Cosmetic Act to prevent the abuse of dextromethorphan, and for other purposes.
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DEVICE Act of 2019 Disclosure; and Encouragement of Verification, Innovation, Cleaning, and Efficiency Act of 2019 [HB-818]
Addresses design changes and reprocessing of medical devices. Reprocessing of medical devices is the process to clean and sterilize or disinfect devices for reuse. Specifically, medical device manufacturers must notify the Food and Drug Administration (FDA) (1) before making changes to the design or reprocessing instructions of a device, and (2) no more than five days after widely disseminating to health care providers in a foreign country communications regarding changes to the design or reprocessing instructions of a device or regarding a safety
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Middle Class Health Benefits Tax Repeal Act of 2019 [HB-748]
Responds to the COVID-19 (i.e., coronavirus disease 2019) outbreak and its impact on the economy, public health, state and local governments, individuals, and businesses. DIVISION A--KEEPING WORKERS PAID AND EMPLOYED, HEALTH CARE SYSTEM ENHANCEMENTS, AND ECONOMIC STABILIZATION This division establishes the Paycheck Protection Program to provide eight weeks of cash flow assistance to small businesses through federally guaranteed loans to employers who maintain their payroll. Such assistance shall be to cover costs such as payroll, paid sick leave,
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Medical Cannabis Research Act of 2019 [HB-601]
Establishes a new, separate registration process for manufacturers of cannabis for research. As a part of this process, the Drug Enforcement Administration must annually assess whether there is an adequate and uninterrupted supply of research cannabis and register additional manufacturers. The bill also authorizes health care providers of the Department of Veterans Affairs to provide information to veterans regarding participation in federally approved cannabis clinical trials.
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Biological Implant Tracking and Veteran Safety Act of 2019 [HB-547]
Requires the Department of Veterans Affairs (VA) to adopt and implement a device identification system for use in identifying biological implants intended for use in medical procedures conducted in VA facilities. The VA may adopt the system developed by the Food and Drug Administration (FDA) or may develop its own comparable system. Additionally, the VA shall implement a compatible system for tracking the biological implants from human donor or animal source to implantation. The bill requires the VA to implement compatible inventory controls so
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Safe and Affordable Drugs from Canada Act of 2019 [HB-478]
Requires the Food and Drug Administration (FDA) to promulgate regulations within 180 days permitting individuals to import a prescription drug purchased from an approved Canadian pharmacy if the drug is dispensed by a pharmacist licensed in Canada; is purchased for personal use in quantities not greater than a 90-day supply; is filled using a valid prescription issued by a physician licensed to practice in the United States; and has the same active ingredients, route of administration, dosage form, and strength as a prescription drug approved by
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Prescription Drug Price Relief Act of 2019 [HB-465]
Establishes a series of oversight and disclosure requirements relating to the prices of brand-name drugs. Specifically, the bill requires the Department of Health and Human Services (HHS) to review at least annually all brand-name drugs for excessive pricing; HHS must also review prices upon petition. If any such drugs are found to be excessively priced, HHS must (1) void any government-granted exclusivity; (2) issue open, nonexclusive licenses for the drugs; and (3) expedite the review of corresponding applications for generic drugs and biosimilar
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Affordable and Safe Prescription Drug Importation Act [HB-447]
Addresses the importation of drugs from Canada and other foreign countries. The bill requires the Food and Drug Administration (FDA) to promulgate regulations within 180 days permitting wholesalers, pharmacies, and individuals to import certain prescription drugs from Canada. After two years, The FDA, may permit the importation of prescription drugs from other countries. The bill establishes a process for certifying foreign sellers—a licensed foreign pharmacy or foreign wholesale distributor.
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Pandemic and All-Hazards Preparedness and Advancing Innovation Act of 2019 [HB-269]
(1) reauthorizes, revises, and establishes several programs and entities relating to public-health emergency preparedness and response; and (2) addresses the approval process for over-the counter (OTC) drugs. Among other programs, the bill reauthorizes through FY2023 and revises the Public Health Emergency Preparedness cooperative-agreement program administered by the Centers for Disease Control and Prevention (CDC), the Hospital Preparedness Program, the CDC situational-awareness and biosurveillance program, the Emergency System for Advance Registration
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DOSE Act Disposal of Opioids Safely and Effectively Act of 2018 [HB-6205]
DOSE Act Disposal of Opioids Safely and Effectively Act of 2018
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Informing Opioid Prescribing Through Evidence-Based Guidelines Act of 2018 [HB-6133]
Informing Opioid Prescribing Through Evidence-Based Guidelines Act of 2018
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Addiction Prevention and Responsible Opioid Practices Act [HB-5865]
Addiction Prevention and Responsible Opioid Practices Act
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21st Century Tools for Pain and Addiction Treatment Act [HB-5806]
21st Century Tools for Pain and Addiction Treatment Act
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Long-Term Opioid Efficacy Act of 2018 [HB-5811]
Long-Term Opioid Efficacy Act of 2018
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Opioid Addiction Recovery Fraud Prevention Act of 2018 [S.2842]
Opioid Addiction Recovery Fraud Prevention Act of 2018
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Opioid Crisis Accountability Act of 2018 [HB-5782]
Opioid Crisis Accountability Act of 2018