Drug Safety, Medical Device, And Laboratory Regulation
US Congress 115th Congress
Right to Try Act [HB-2368]
Right to Try Act This bill requires the federal government to allow unrestricted manufacturing, distribution, prescribing, and dispensing of experimental drugs, biological products, and medical devices that are authorized by state law and intended to treat terminally ill patients. Patients receiving these treatments must be certified by a physician as having exhausted all other treatment options and as being at greater risk from their medical condition than the treatment. The physician must explain the treatment to the patient, including that the
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FDA Reporting Transparency and Accountability Act [S.1062]
FDA Reporting Transparency and Accountability Act
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CREATES Act of 2017 Creating and Restoring Equal Access To Equivalent Samples Act of 2017 [HB-2212]
CREATES Act of 2017 Creating and Restoring Equal Access To Equivalent Samples Act of 2017
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CREATES Act of 2018 Creating and Restoring Equal Access to Equivalent Samples Act of 2018 [S.974]
CREATES Act of 2018 Creating and Restoring Equal Access to Equivalent Samples Act of 2018
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Medical Device Guardians Act [HB-2163]
Medical Device Guardians Act
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Supporting State, local, and community initiatives to encourage parents, teachers, camp counselors, and childcare professionals to take measures to prevent sunburns in the minors they care for, and expressing the sense of the House of Representatives that State, local, and community entities should continue to support efforts to curb the incidences of skin cancer beginning with childhood skin protection. [HR-282]
Supporting State, local, and community initiatives to encourage parents, teachers, camp counselors, and childcare professionals to take measures to prevent sunburns in the minors they care for, and expressing the sense of the House of Representatives that State, local, and community entities should continue to support efforts to curb the incidences of skin cancer beginning with childhood skin protection. Expresses support for efforts to: (1) exempt sunscreen from over-the-counter medication bans in schools, and (2) encourage health care professionals
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FDA Reauthorization Act of 2017 [S.934]
FDA Reauthorization Act of 2017 TITLE I--FEES RELATING TO DRUGS Prescription Drug User Fee Amendments of 2017 (Sec. 102) This bill amends the Federal Food, Drug, and Cosmetic Act to extend through FY2022 and revise Food and Drug Administration (FDA) user fees for new drug applications. User fees are eliminated for supplements to new drug applications and drug manufacturing facilities. TITLE II--FEES RELATING TO DEVICES Medical Device User Fee Amendments of 2017 (Sec. 203) The bill extends through FY2022 and revises FDA user fees for medical devices.
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Speeding Access to Already Approved Pharmaceuticals Act of 2017 [HB-2113]
Speeding Access to Already Approved Pharmaceuticals Act of 2017 This bill amends the Federal Food, Drug, and Cosmetic Act to require the Food and Drug Administration to facilitate the development and expedite the review of a new drug, biological product, or medical device that has been approved in the European Union.
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FAST Generics Act of 2017 Fair Access for Safe and Timely Generics Act of 2017 [HB-2051]
FAST Generics Act of 2017 Fair Access for Safe and Timely Generics Act of 2017 This bill amends the Federal Food, Drug, and Cosmetic Act to prohibit the license holder of a Food and Drug Administration (FDA)-approved drug or biological product from restricting availability of the medication for testing by a product developer seeking to develop a drug, generic drug, or biosimilar, including restricting availability with a risk evaluation and mitigation strategy (REMS). Upon request, the license holder of a medication that is not subject to a REMS
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Abuse-Deterrent Opioids Plan for Tomorrow Act of 2017 [HB-2025]
Abuse-Deterrent Opioids Plan for Tomorrow Act of 2017 This bill amends the Federal Food, Drug, and Cosmetic Act to prevent an application for a new drug from being considered ineligible for approval because its labeling includes information describing abuse-deterrent properties that otherwise would be blocked by market exclusivity provisions. The Department of Health and Human Services shall issue draft guidance and publish final guidance regarding the award and scope of exclusivity for new drugs with properties designed to deter abuse and the exceptions
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Pharmaceutical Information Exchange Act [HB-2026]
Pharmaceutical Information Exchange Act This bill amends the Federal Food, Drug, and Cosmetic Act to allow information about a new investigational medication or the investigational use of a medication approved by the Food and Drug Administration to be provided to health care entities if the information is based on reliable scientific evidence.
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Reinvigorating Antibiotic and Diagnostic Innovation Act of 2017 [HB-1840]
Reinvigorating Antibiotic and Diagnostic Innovation Act of 2017 This bill amends the Internal Revenue Code to allow tax credits for 50% of the clinical testing expenses for: (1) infectious disease products that are intended to treat a serious or life-threatening infection, including one caused by an antibacterial or antifungal resistant pathogen or a qualifying pathogen listed by the Department of Health and Human Services as having the potential to pose a serious threat to public health; and (2) in-vitro diagnostic devices that identify in less
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Improving Access To Affordable Prescription Drugs Act [HB-1776]
Improving Access To Affordable Prescription Drugs Act This bill amends provisions of various laws relating to prescription-drug pricing and affordability. Specifically, the bill: expands reporting requirements for drug manufacturers and establishes corresponding civil penalties for noncompliance; adds reporting requirements for certain nonprofit patient-assistance programs; requires the Government Accountability Office (GAO) to report to Congress on the impact of patient-assistance programs on prescription-drug pricing and expenditures; requires
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Sponsored by: Rep. Sean Maloney Referred To The Subcommittee On Health. on 04/05/2017
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Improving Access To Affordable Prescription Drugs Act [S.771]
Improving Access To Affordable Prescription Drugs Act This bill amends provisions of various laws relating to prescription-drug pricing and affordability. Specifically, the bill: expands reporting requirements for drug manufacturers and establishes corresponding civil penalties for noncompliance; adds reporting requirements for certain nonprofit patient-assistance programs; requires the Government Accountability Office (GAO) to report to Congress on the impact of patient-assistance programs on prescription-drug pricing and expenditures; requires
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