Drug Safety, Medical Device, And Laboratory Regulation
US Congress 115th Congress
Stop Illicit Drug Importation Act of 2018 [HB-5752]
Stop Illicit Drug Importation Act of 2018
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SOUND Disposal and Packaging Act Securing Opioids and Unused Narcotics with Deliberate Disposal and Packaging Act of 2018 [HB-5687]
SOUND Disposal and Packaging Act Securing Opioids and Unused Narcotics with Deliberate Disposal and Packaging Act of 2018 This bill amends the Federal Food, Drug, and Cosmetic Act to authorize the Food and Drug Administration to require certain packaging and disposal technologies, controls, or measures to mitigate the risk of abuse or misuse of a drug or a class of drugs.
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Medical Cannabis Research Act of 2018 [HB-5634]
Medical Cannabis Research Act of 2018
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MEDS Act Marijuana Effective Drug Studies Act of 2017 [S.1803]
MEDS Act Marijuana Effective Drug Studies Act of 2017 This bill amends the Controlled Substances Act to establish a new, separate registration process to facilitate research involving marijuana and the commercial production of drugs made from marijuana. Specifically, the bill requires the Drug Enforcement Administration to register manufacturers and distributors to supply marijuana: (1) for use in research, and (2) for the commercial production of approved drugs containing or derived from marijuana.
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Animal Drug and Animal Generic Drug User Fee Amendments of 2018 [HB-5554]
Animal Drug and Animal Generic Drug User Fee Amendments of 2018
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Water, Cosmetics, and Unwanted Pharmaceuticals Study Act [HB-5548]
Water, Cosmetics, and Unwanted Pharmaceuticals Study Act This bill amends the Safe Drinking Water Act to require the Environmental Protection Agency to carry out a study on the presence of pharmaceuticals and personal care products in sources of drinking water. The study must identify: pharmaceuticals and personal care products that have been detected in the sources; the levels at which the pharmaceuticals and products have been detected; the origins of pharmaceuticals and products found in drinking water; the effects of the pharmaceuticals and
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Opioid Crisis Response Act of 2018 [S.2680]
Opioid Crisis Response Act of 2018
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Over-the-Counter Drug Safety, Innovation, and Reform Act [S.2315]
Over-the-Counter Drug Safety, Innovation, and Reform Act
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MEDS Act Marijuana Effective Drug Studies Act of 2018 [HB-4825]
MEDS Act Marijuana Effective Drug Studies Act of 2018 This bill amends the Controlled Substances Act to establish a new, separate registration process to facilitate research involving marijuana and the commercial production of drugs made from marijuana. Specifically, the bill requires the Drug Enforcement Administration to register manufacturers and distributors to supply marijuana: (1) for use in research, and (2) for the commercial production of approved drugs containing or derived from marijuana.
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Respond NOW Act Respond to the Needs in the Opioid War Act [HB-4938]
Respond NOW Act Respond to the Needs in the Opioid War Act
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Safe Disposal of Unused Medication Act [HB-5041]
Safe Disposal of Unused Medication Act (Sec. 2) This bill amends the Controlled Substances Act to allow a hospice employee to handle lawfully dispensed controlled substances of a deceased hospice patient to assist with disposal of the controlled substances, so long as such disposal occurs onsite in accordance with applicable law.
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SCREEN Act Stop Counterfeit Drugs by Regulating and Enhancing Enforcement Now Act [HB-5228]
SCREEN Act Stop Counterfeit Drugs by Regulating and Enhancing Enforcement Now Act
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Patient Right to Know Drug Prices Act [S.2554]
Patient Right to Know Drug Prices Act
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Trickett Wendler, Frank Mongiello, Jordan McLinn, and Matthew Bellina Right to Try Act of 2018 [HB-5247]
Trickett Wendler, Frank Mongiello, Jordan McLinn, and Matthew Bellina Right to Try Act of 2018
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Off Fossil Fuels for a Better Future Act [HB-3671]
Off Fossil Fuels for a Better Future Act This bill transitions away from fossil fuel sources of energy to clean energy sources (e.g., energy efficiency, energy conservation, and renewable energy). By 2027: (1) 80% of electricity sold must be generated from clean energy resources, (2) 80% of new vehicle sales from manufacturers must be sales of zero-emission vehicles, and (3) 80% of train rail lines and train engines must be electrified. By 2035: (1) 100% of electricity must be generated from clean energy resources, (2) 100% of vehicle sales from
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Medical Marijuana Research Act of 2017 [HB-3391]
Medical Marijuana Research Act of 2017 This bill amends the Controlled Substances Act to establish a new, separate registration process to facilitate research with marijuana for medical purposes. The Drug Enforcement Administration must register: (1) practitioners to conduct medical marijuana research, and (2) manufacturers and distributors to supply marijuana for such research. The Department of Health and Human Services must continue to produce marijuana through the National Institute on Drug Abuse Drug Supply Program and offer to sell immature
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Interior and Environment, Agriculture and Rural Development, Commerce, Justice, Science, Financial Services and General Government, Homeland Security, Labor, Health and Human Services, Education, State and Foreign Operations, Transportation, Housing and Urban Development, Defense, Military Construction and Veterans Affairs, Legislative Branch, and Energy and Water Development Appropriations Act, 2018 Make America Secure and Prosperous Appropriations Act, 2018 [HB-3354]
Interior and Environment, Agriculture and Rural Development, Commerce, Justice, Science, Financial Services and General Government, Homeland Security, Labor, Health and Human Services, Education, State and Foreign Operations, Transportation, Housing and Urban Development, Defense, Military Construction and Veterans Affairs, Legislative Branch, and Energy and Water Development Appropriations Act, 2018 Make America Secure and Prosperous Appropriations Act, 2018 DIVISION A--DEPARTMENT OF THE INTERIOR, ENVIRONMENT, AND RELATED AGENCIES APPROPRIATIONS
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Adding Middle East Respiratory Syndrome to the FDA Priority Review Voucher Program Act [HB-3348]
Adding Middle East Respiratory Syndrome to the FDA Priority Review Voucher Program Act This bill amends the Federal Food, Drug, and Cosmetic Act to include Middle East respiratory syndrome under the priority review voucher program for tropical diseases, which awards a voucher to the sponsor of a new drug or biological product that is approved to prevent or treat a tropical disease. (A voucher entitles the holder to have a future new drug or biological product application acted upon by the Food and Drug Administration within six months.)
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Orphan Products Extension Now Accelerating Cures and Treatments Act of 2017 [S.1509]
Orphan Products Extension Now Accelerating Cures and Treatments Act of 2017 This bill amends the Federal Food, Drug, and Cosmetic Act to require the Food and Drug Administration (FDA) to extend by six months the exclusivity period for an approved drug or biological product when the product is additionally approved to prevent, diagnose, or treat a new indication that is a rare disease or condition (also known as an orphan disease). The FDA may revoke an extension if the application for the new indication contained an untrue material statement. The
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SUPPORT for Patients and Communities Act Substance Use-Disorder Prevention that Promotes Opioid Recovery and Treatment for Patients and Communities Act [HB-6]
SUPPORT for Patients and Communities Act Substance Use-Disorder Prevention that Promotes Opioid Recovery and Treatment for Patients and Communities Act TITLE I--MEDICAID PROVISIONS TO ADDRESS THE OPIOID CRISIS (Sec. 1001) The bill prohibits termination of Medicaid eligibility for juveniles who are inmates of public institutions. (Sec. 1003) The Centers for Medicare & Medicaid Services (CMS) must establish a demonstration project to increase provider treatment capacity for substance-use disorders. (Sec. 1004) State Medicaid programs must establish
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