Drug Safety, Medical Device, And Laboratory Regulation
US Congress 114th Congress
Rare Disease Innovation Act [S.2188]
Rare Disease Innovation Act This bill amends the Federal Food, Drug, and Cosmetic Act to expand the humanitarian device exemption to authorize the Food and Drug Administration (FDA) to exempt from effectiveness requirements certain medical devices intended to benefit fewer than 8,000 individuals. Currently, the FDA may exempt devices intended to benefit fewer than 4,000 individuals. Within 18 months of enactment of this Act, the FDA must define “probable benefit” for these devices. The FDA must report every five years on the effect of this expansion
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FDA Regulatory Efficiency Act [S.2187]
FDA Regulatory Efficiency Act This bill amends the Federal Food, Drug, and Cosmetic Act to require the Food and Drug Administration (FDA) to establish a third-party quality system assessment program to accredit persons to assess whether a medical device manufacturer's quality system can ensure the safety and effectiveness or substantial equivalence of an approved medical device after certain changes, including changes in manufacturing or changes to enhance device safety. Device manufacturers with quality systems that have been certified by an accredited
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An Act Making Appropriations to Improve the Nation's Infrastructure and for Other Purposes, 2016 [S.2129]
An Act Making Appropriations to Improve the Nation's Infrastructure and for Other Purposes, 2016 Provides FY2016 appropriations to the Department of Agriculture (USDA), the Food and Drug Administration (FDA), the U.S. Army Corps of Engineers, the Department of the Interior's Bureau of Reclamation, the Department of Energy (DOE), the Department of Transportation (DOT), the Department of Housing and Urban Development (HUD), and several independent and related agencies. Agriculture, Rural Development, Food and Drug Administration, and Related Agencies
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Medical Countermeasure Innovation Act of 2016 [S.2055]
Medical Countermeasure Innovation Act of 2016 (Sec. 2) This bill amends the Public Health Service Act to require the Department of Health and Human Services (HHS) to ensure the issuance of timely and accurate guidelines regarding the use of medical products for countering public health emergencies or material threats. HHS must report on funding for procurement of medical countermeasures when available funds are below a specified amount. (Sec. 3) The Biomedical Advanced Research and Development Authority's (BARDA's) contracting authority for procurement
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Promoting Life-Saving New Therapies for Neonates Act of 2015 [S.2041]
Promoting Life-Saving New Therapies for Neonates Act of 2015 This bill amends the Federal Food, Drug, and Cosmetic Act to require the Food and Drug Administration (FDA) to award the sponsor of a new drug or biological product for the treatment of newborns a neonatal drug exclusivity voucher upon approval of the medication. A neonatal drug exclusivity voucher is a transferable voucher for a one-year extension of all existing patents and marketing exclusivities for a brand name medication. For a sponsor to be eligible for a voucher, the new medication
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Advancing Targeted Therapies for Rare Diseases Act of 2016 [S.2030]
Advancing Targeted Therapies for Rare Diseases Act of 2016 (Sec. 2) This bill amends the Federal Food, Drug, and Cosmetic Act to permit the Food and Drug Administration to allow the sponsor of a new drug or biological product for the treatment of a rare, serious condition to rely upon information submitted for an approved medication that uses the same technology. For a sponsor to be eligible to rely upon submitted information: (1) the sponsor must have developed, or have a right of reference to, the relied upon information; and (2) the new medication
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Orphan Drug Fairness Act [S.1906]
Orphan Drug Fairness Act This bill amends the Patient Protection and Affordable Care Act (PPACA) to exclude sales of any drug or biological product approved by the Food and Drug Administration solely for rare diseases or conditions (orphan drug) from the calculation of the annual fee on manufacturers or importers with branded prescription drug sales exceeding $5 million. This Act is effective as if included in PPACA.
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Childhood Cancer STAR Act Childhood Cancer Survivorship, Treatment, Access, and Research Act of 2015 [S.1883]
Childhood Cancer STAR Act Childhood Cancer Survivorship, Treatment, Access, and Research Act of 2015 This bill amends the Public Health Service Act to permit the National Institutes of Health (NIH) to provide support to collect the medical specimens and information of children, adolescents, and young adults with cancer to improve the understanding of these cancers and of the effects of treatment. The national childhood cancer registry is reauthorized through FY2020 and revised to require the Centers for Disease Control and Prevention to award grants
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Advancing Hope Act of 2016 [S.1878]
Advancing Hope Act of 2016 This bill amends the Federal Food, Drug, and Cosmetic Act to expand the priority review voucher program for rare pediatric diseases to include treatments for sickle cell disease and pediatric cancers. The voucher program is extended by removing the provision terminating the program one year after the Food and Drug Administration's (FDA's) issuance of three rare pediatric disease vouchers. A voucher may not be issued for a rare pediatric disease product if a voucher was issued for the product as a tropical disease product.
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PATH Act Promise for Antibiotics and Therapeutics for Health Act [S.185]
PATH Act Promise for Antibiotics and Therapeutics for Health Act Amends the Federal Food, Drug, and Cosmetic Act to require the Food and Drug Administration (FDA) to establish a program to approve as a limited population antibacterial drug an antibacterial drug intended to treat a serious medical condition and to address an unmet medical need within an identifiable limited population. Requires the FDA's determination of the safety and effectiveness of these drugs to reflect the drug's benefit-risk profile in the intended limited population. Prohibits
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Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act, 2016 [S.1800]
Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act, 2016 Provides FY2016 appropriations to the Department of Agriculture (USDA), the Food and Drug Administration (FDA), and related agencies. TITLE I--AGRICULTURAL PROGRAMS Provides appropriations for the following agricultural programs and services: the Office of the Secretary; Executive Operations; the Office of the Chief Information Officer; the Office of the Chief Financial Officer; the Office of the Assistant Secretary for Civil Rights; the Office
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Safe and Affordable Prescription Drugs Act of 2015 [S.1790]
Safe and Affordable Prescription Drugs Act of 2015 Amends the Federal Food, Drug, and Cosmetic Act (FFDCA) to require the Department of Health and Human Services (HHS) to promulgate regulations within 180 days permitting individuals to import a prescription drug purchased from an approved foreign pharmacy that: is dispensed by a pharmacist licensed in that country; 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
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Combination Product Regulatory Fairness Act of 2016 [S.1767]
Combination Product Regulatory Fairness Act of 2016 This bill amends the Federal Food, Drug, and Cosmetic Act to require the Food and Drug Administration (FDA) to provide the sponsor of a product the scientific rationale supporting a determination that the product is not a medical device before making that determination. If the FDA preliminarily determines that a product is not a medical device, the sponsor may propose a study to inform the product's classification. The FDA is prohibited from determining that a combination product (a product that
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AIM Act of 2015 Accelerating Innovation in Medicine Act of 2015 [S.1757]
AIM Act of 2015 Accelerating Innovation in Medicine Act of 2015 Amends title XVIII (Medicare) of the Social Security Act to direct the Department of Health and Human Services (HHS) to develop an accelerating innovation in medicine (AIM) list of medical devices (or for any items or services related to furnishing such devices) for which, because of their inclusion on the list, insurance benefits and payments are prohibited under Medicare (either directly or on a capitated basis), with the result that no Medicare claim may be submitted and an individual
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Comprehensive Transportation and Consumer Protection Act of 2015 [S.1732]
Comprehensive Transportation and Consumer Protection Act of 2015 This bill establishes in the Department of Transportation (DOT) Office of the Secretary an Interagency Infrastructure Permitting Improvement Center to support modernization efforts at federal agencies and interagency pilots for innovative approaches to the permitting and review of infrastructure projects. DOT shall establish a national multimodal freight network and develop a national freight strategic plan. States shall develop a freight investment plan. DOT shall develop a five-year
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FDA Device Accountability Act of 2016 [S.1622]
FDA Device Accountability Act of 2016 This bill amends the Federal Food, Drug, and Cosmetic Act to require the Food and Drug Administration (FDA) to ensure that employees who review premarket submissions of medical devices receive training on least burdensome requirements. (Currently, the FDA is required to consider the least burdensome appropriate means for a device sponsor to demonstrate the effectiveness of a device or its substantial equivalence to an approved device.) The FDA must periodically assess the implementation of those requirements.
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Department of Homeland Security Appropriations Act, 2016 [S.1619]
Department of Homeland Security Appropriations Act, 2016 Provides FY2016 appropriations for the Department of Homeland Security (DHS). TITLE I--DEPARTMENTAL MANAGEMENT AND OPERATIONS Provides appropriations for: (1) the Office of the Secretary and Executive Management, (2) the Office of the Under Secretary for Management, (3) the Office of the Chief Financial Officer, (4) the Office of the Chief Information Officer, (5) Analysis and Operations, and (6) the Office of Inspector General. Requires DHS to submit to Congress a comprehensive plan for implementation
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Patient-Focused Impact Assessment Act of 2016 [S.1597]
Patient-Focused Impact Assessment Act of 2016 (Sec. 2) This bill amends the Federal Food, Drug, and Cosmetic Act to require the Food and Drug Administration (FDA), after approving an application for a new medication, to publish a brief statement on any patient experience data or related information that was part of the application. Patient experience data is information about the impact of a medical condition or a related therapy on a patient's life and the patient's preferences for treatment. (Sec. 3) The FDA must issue guidance on the collection
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Affordability Is Access Act [S.1532]
Affordability Is Access Act This bill amends the Public Health Service Act to require health insurance and group health plans to cover, as preventive care for women, over-the-counter oral contraceptives for daily use, regardless of whether an enrollee has a prescription for the contraceptive. (Insurers and plans cannot impose cost sharing for preventive care.)
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Allowing Greater Access to Safe and Effective Contraception Act [S.1438]
Allowing Greater Access to Safe and Effective Contraception Act This bill requires the Food and Drug Administration (FDA) to prioritize review of supplemental drug applications (applications to modify the approved use of a drug) for contraceptive drugs intended for routine use that would be available to individuals aged 18 and older without a prescription. The FDA must waive user fees for such supplemental drug applications. Any drug that is eligible for this priority review must be a prescription drug for individuals under age 18. This bill repeals
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