Drug Safety, Medical Device, And Laboratory Regulation
US Congress 114th Congress
Traditional Cigar Manufacturing and Small Business Jobs Preservation Act of 2015 [HB-662]
Traditional Cigar Manufacturing and Small Business Jobs Preservation Act of 2015 Amends the Federal Food, Drug, and Cosmetic Act to exempt traditional large and premium cigars from regulation by the Food and Drug Administration (FDA) and from user fees assessed on tobacco products by the FDA.
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Improving Regulatory Transparency for New Medical Therapies Act [HB-639]
Improving Regulatory Transparency for New Medical Therapies Act (Sec. 2) This bill amends the Federal Food, Drug, and Cosmetic Act and the Public Health Service Act to delay the effective date of approval of a drug, biological product, or animal drug for which the Food and Drug Administration (FDA) recommends controls under the Controlled Substances Act until the Department of Justice (DOJ) issues a final interim rule for the drug. This delay also applies to conditional approval and indexing of animal drugs. This bill amends the Controlled Substances
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Clinical Trial Cancer Mission 2020 Act [HB-617]
Clinical Trial Cancer Mission 2020 Act Amends the Public Health Service Act to revise clinical trial registry data bank provisions to specify that a device or drug clinical trial must be included in the clinical trial registry data bank regardless of whether it results in a positive or negative outcome. Requires the responsible party of any clinical trials funded in whole or in part by the Department of Defense (DOD) to certify in all required grant or progress forms that the required submissions to the clinical trial registry data bank have been
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Water, Cosmetics, and Unwanted Pharmaceuticals Study Act [HB-6128]
Water, Cosmetics, and Unwanted Pharmaceuticals Study Act
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Safe Drinking Water Act Amendments of 2016 [HB-6116]
Safe Drinking Water Act Amendments of 2016
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21st Century Cures Act [HB-6]
21st Century Cures Act (Sec. 2) The NIH and Cures Innovation Fund is established and funds are appropriated: (1) for biomedical research, including high-risk, high-reward research and research conducted by early stage investigators; (2) to develop and implement a strategic plan for biomedical research; and (3) to carry out specified provisions of this Act. TITLE I--DISCOVERY Subtitle A--National Institutes of Health Funding (Sec. 1001) This bill amends the Public Health Service Act to reauthorize the National Institutes of Health (NIH) through FY2018.
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Accurate Labeling of Menstrual Products Act of 2016 [HB-5916]
Accurate Labeling of Menstrual Products Act of 2016 This bill amends the Federal Food, Drug, and Cosmetic Act to require menstrual cups, menstrual pads, tampons, and therapeutic vaginal douche apparatuses to include a list of ingredients on the label.
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RACE for Children Act Research to Accelerate Cures and Equity for Children Act [HB-5858]
RACE for Children Act Research to Accelerate Cures and Equity for Children Act
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Addiction Prevention and Responsible Opioid Practices Act [HB-5655]
Addiction Prevention and Responsible Opioid Practices Act
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Department of Homeland Security Appropriations Act, 2017 [HB-5634]
Department of Homeland Security Appropriations Act, 2017 Provides FY2017 appropriations to the Department of Homeland Security (DHS). Provides appropriations for Departmental Management, Operations, Intelligence, and Oversight for: Departmental Management and Operations, Analysis and Operations, and the Office of Inspector General. Provides appropriations for Security, Enforcement, and Investigations for: U.S. Customs and Border Protection, U.S. Immigration and Customs Enforcement, the Transportation Security Administration, the U.S. Coast Guard,
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Carl's Law [HB-5601]
Carl's Law This bill amends the Federal Food, Drug, and Cosmetic Act to require the label of a drug containing an opioid to prominently state that the drug contains an opioid and addiction to the drug is possible. (Opioids are drugs with effects similar to opium, such as certain pain medications.)
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PRICED Act Price Relief, Innovation, and Competition for Essential Drugs Act [HB-5573]
PRICED Act Price Relief, Innovation, and Competition for Essential Drugs Act This bill amends the Public Health Service Act to allow biosimilars to be marketed seven years after the reference brand name biological product is licensed. Currently, brand name biological products are provided a 12-year marketing exclusivity period. This shortened marketing exclusivity period applies only to biological products licensed by the Food and Drug Administration after enactment of this bill.
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Medical Marijuana Research Act of 2016 [HB-5549]
Medical Marijuana Research Act of 2016
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Health Equity and Accountability Act of 2016 [HB-5475]
Health Equity and Accountability Act of 2016
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FDA Cross-Center Collaboration Act of 2016 [HB-5414]
FDA Cross-Center Collaboration Act of 2016 This bill amends the Federal Food, Drug, and Cosmetic Act to require the Food and Drug Administration (FDA) to establish one or more Intercenter Institutes. Each institute must coordinate activities applicable to a major disease area among the FDA centers that review products. Activities may include coordinating staff with relevant expertise, streamlining product review, and enhancing interactions with patients, sponsors, and the biomedical community.
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Medical Device Guardians Act of 2016 [HB-5404]
Medical Device Guardians Act of 2016
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Alzheimer's Breakthrough Sunshine Act [HB-5366]
Alzheimer's Breakthrough Sunshine Act This bill amends the Internal Revenue Code to exclude from gross income for seven years amounts received from the sale of certain drugs for treating Alzheimer's disease and related dementias. The exclusion applies to the sale of a drug approved or licensed as a disease-modifying treatment for Alzheimer's disease and that has been designated as a breakthrough therapy under the Federal Food, Drug, and Cosmetic Act. The drug must be sold through an arm's length transaction by a holder of the approved application
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Legislative Branch Appropriations Act, 2017 [HB-5325]
Legislative Branch Appropriations Act, 2017 (Sec. 3) Specifies that references to "this Act" included in any division refer only to the provisions of the division unless the bill expressly provides otherwise. (Sec. 4) Specifies that the sums in this bill are appropriated out of any money in the Treasury not otherwise appropriated for FY2017. (Sec. 5) Specifies that each amount in this bill designated by Congress as an emergency requirement is contingent on the President also designating all of the emergency amounts and transmitting the designations
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Safe Medications for Moms and Babies Act of 2016 [HB-5219]
Safe Medications for Moms and Babies Act of 2016
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Safe Drug Disposal Tax Credit Act of 2016 [HB-5194]
Safe Drug Disposal Tax Credit Act of 2016 This bill amends the Internal Revenue Code to establish a tax credit for 30% of the program costs of an entity to establish or maintain a drug disposal site where individuals can deposit drugs to be disposed of legally at no cost to the individual. The credit includes the costs of materials for the site, outreach and training about the use of the site, and the safe disposal of drugs collected at the site.