Drug Safety, Medical Device, And Laboratory Regulation
US Congress 113th Congress
Orphan Product Extensions Now Accelerating Cures and Treatments Act of 2014 [HB-5750]
Orphan Product Extensions Now Accelerating Cures and Treatments Act of 2014
Spread the world
Gettr US Congress 113th Congress
Adding Ebola to the FDA Priority Review Voucher Program Act [HB-5729]
Adding Ebola to the FDA Priority Review Voucher Program Act - Amends the Federal Food, Drug, and Cosmetic Act to add filoviruses, a family of viruses that includes the Ebola virus, to the list of tropical diseases under the priority review voucher program, which awards vouchers to sponsors of human drug applications that are approved to prevent or treat tropical diseases. (A voucher entitles the holder to have a future human drug application acted upon by the Food and Drug Administration (FDA) within six months.) Changes the process by which infectious
(continued...)
Spread the world
US Congress 113th Congress
Ebola Emergency Response Act [HB-5710]
Ebola Emergency Response Act - Expresses the sense of Congress that: the Ebola virus outbreak in West Africa poses severe health, economic, and security threats to the affected countries, the United States, and the broader international community; and the whole-of-government response taken by the United States provides capabilities critical to helping contain Ebola in West Africa; yet the United States alone will not succeed in containing it. Directs the President to: coordinate with the governments of affected African countries, the private
(continued...)
Spread the world
US Congress 113th Congress
Fair Access for Safe and Timely Generics Act of 2014 [HB-5657]
Fair Access for Safe and Timely Generics Act of 2014
Spread the world
US Congress 113th Congress
Protecting Our Kids' Medicine Act of 2014 [HB-5613]
Protecting Our Kids' Medicine Act of 2014 - Amends the Federal Food, Drug, and Cosmetic Act to prohibit the sale of liquid formulations of over-the-counter drugs that are not packaged with a dosage delivery device, such as a calibrated cup or spoon, and that do not have measurements on the label and on the dosage delivery device exclusively in metric units. Allows the Secretary of Health and Human Services (HHS) to waive the requirement for metric units if that requirement would not benefit public health. Prohibits the sale of over-the-counter liquid
(continued...)
Spread the world
US Congress 113th Congress
Opioid Abuse Prevention and Treatment Act of 2014 [HB-5587]
Opioid Abuse Prevention and Treatment Act of 2014 - Requires the Secretary of Health and Human Services (HHS) to award grants to states to develop a peer review process to identify and investigate questionable or inappropriate prescribing and dispensing patterns of drugs classified as schedule II or III under the Controlled Substances Act, which are drugs with an accepted medical use that have the potential to be abused and addictive. Amends the Public Health Service Act to require the Secretary to establish grant programs to: (1) facilitate training
(continued...)
Spread the world
US Congress 113th Congress
CHIP Extension and Improvement Act of 2014 [HB-5364]
CHIP Extension and Improvement Act of 2014 - Revises and extends through FY2019 at generally increased levels the program under title XXI (State Children's Health Insurance) (CHIP) of the Social Security Act (SSA), and adjusts CHIP allotment requirements accordingly, including the rebasing and growth factor update rules for computing state allotments. Makes appropriations for certain allotments. Directs the Secretary of Health and Human Services (HHS) to make payments to shortfall states from the Child Enrollment Contingency Fund in each of FY2016-FY2019.
(continued...)
Spread the world
US Congress 113th Congress
Infection Reduction Labeling Act of 2014 [HB-5350]
Infection Reduction Labeling Act of 2014 - Amends the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) to authorize solid antimicrobial copper alloys, and products made from such alloys, to be marketed, distributed, or sold with labels about their infection reduction and control efficacy if the antimicrobial claims made on the label are consistent with the results of federally-funded clinical trials finding: (1) greater than 25% reductions in infection rate or 50% reductions in microbial burden, or (2) statistically significant reductions
(continued...)
Spread the world
US Congress 113th Congress
Health Equity and Accountability Act of 2014 [HB-5294]
Health Equity and Accountability Act of 2014 - Amends the Public Health Service Act and the Social Security Act to expand the collection and analysis of data in programs of the Department of Health and Human Services (HHS). Sets forth provisions to improve cultural competence in federal health care programs and services, including by establishing the Robert T. Matsui Center for Cultural and Linguistic Competence in Health Care. Requires the Secretary of HHS (Secretary) to engage in activities to improve health workforce diversity, including by:
(continued...)
Spread the world
US Congress 113th Congress
To require the Secretary of Health and Human Services to provide for recommendations for the development and use of clinical data registries for the improvement of patient care. [HB-5214]
Requires the Secretary of Health and Human Services (HHS) to consult with clinical experts and make recommendations for the use of clinical data registries to improve patient care. Directs the Secretary to include in the recommendations: (1) standards to allow exchange of information between electronic health records and registries, (2) how registries can be used to evaluate models and methods of care, (3) how registries can be used to monitor the safety and efficacy of products approved by the Food and Drug Administration (FDA), (4) how registry
(continued...)
Spread the world
US Congress 113th Congress
Speeding Access to Already Approved Pharmaceuticals Act of 2014 [HB-4918]
Speeding Access to Already Approved Pharmaceuticals Act of 2014 - Amends the Federal Food, Drug, and Cosmetic Act to require the Food and Drug Administration (FDA), under procedures for expedited approval of products to treat a serious or life-threatening disease or condition, to facilitate the development and expedite the review of new drugs or devices approved for marketing in the European Union.
Spread the world
US Congress 113th Congress
Microbead-Free Waters Act of 2014 [HB-4895]
Microbead-Free Waters Act of 2014 - Amends the Federal Food, Drug, and Cosmetic Act to prohibit, beginning January 1, 2018, the distribution of a cosmetic that contains synthetic plastic microbeads.
Spread the world
US Congress 113th Congress
Research for All Act of 2014 [HB-4879]
Research for All Act of 2014 - Directs the Food and Drug Administration (FDA) to review and develop policies to ensure that the design and size of clinical trials for products granted expedited approval to treat a serious or life-threatening disease or condition are sufficient to determine the safety and effectiveness of the products for men and women using subgroup analysis. Amends the Federal Food, Drug, and Cosmetic Act to require FDA, at the request of the sponsor of a new drug, to facilitate the development and expedite its review if the drug
(continued...)
Spread the world
US Congress 113th Congress
Stop Tampering of Prescription Pills Act of 2013 [HB-486]
Stop Tampering of Prescription Pills Act of 2013 - Amends the Federal Food, Drug, and Cosmetic Act to prescribe new drug application requirements for abuse-deterrent drugs: (1) containing as an active moiety (the part of the drug that makes it work the way it does) a controlled substance classified as opium, an opiate, or a derivative; (2) formulated for oral administration; (3) exhibiting physicochemical properties making them significantly more difficult or ineffective in altering the drug's characteristics for purposes of misuse or abuse; and
(continued...)
Spread the world
US Congress 113th Congress
Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act, 2015 [HB-4800]
Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act, 2015 - Title I: Agricultural Programs - Appropriates FY2015 funds for the following Department of Agriculture (USDA) programs and services: (1) Office of the Secretary of Agriculture (Secretary); (2) Office of the Chief Economist; (3) National Appeals Division; (4) Office of Budget and Program Analysis; (5) Office of the Chief Information Officer; (6) Office of the Chief Financial Officer; (7) Office of the Assistant Secretary for Civil Rights;
(continued...)
Spread the world
US Congress 113th Congress
Regenerative Medicine Promotion Act of 2014 [HB-4494]
Regenerative Medicine Promotion Act of 2014 - Requires the Comptroller General to submit to Congress a report identifying all ongoing federal programs and activities regarding regenerative medicine. Directs the Secretary of Health and Human Services (HHS) to establish a Regenerative Medicine Coordinating Council in the Office of the Secretary with duties to include: (1) preparing a national strategy to support research into regenerative medicine and the development of drugs, biological products, medical devices, and biomaterials for use in regenerative
(continued...)
Spread the world
US Congress 113th Congress
Compassionate Freedom of Choice Act of 2014 [HB-4475]
Compassionate Freedom of Choice Act of 2014 - Amends the Federal Food, Drug, and Cosmetic Act to declare that nothing in it or in the Public Health Service Act shall prevent or restrict, and the Food and Drug Administration (FDA) shall not implement or enforce any law to prevent or restrict, the manufacture, importation, distribution, or sale of investigational drugs or devices for terminally ill patients. Prohibits the FDA Commissioner from requiring the disclosure, collection, or reporting of certain information concerning such drugs or devices,
(continued...)
Spread the world
US Congress 113th Congress
Biological Implant Tracking and Veteran Safety Act of 2014 [HB-4374]
Biological Implant Tracking and Veteran Safety Act of 2014 - Directs the Secretary of Veterans Affairs to: (1) adopt the unique device identification system developed for medical devices by the Food and Drug Administration (FDA), or implement a comparable standard identification system, for identifying biological implants intended for use in medical procedures conducted in Department of Veterans Affairs (VA) medical facilities; (2) implement a compatible system for tracking the implants from donor to implantation; and (3) implement inventory controls
(continued...)
Spread the world
US Congress 113th Congress
Improving Regulatory Transparency for New Medical Therapies Act [HB-4299]
Improving Regulatory Transparency for New Medical Therapies Act - Amends the Controlled Substances Act to require any proceedings for the issuance, amendment, or repeal of a rule of the Attorney General for the classification of a controlled substance that are initiated at the request of the Secretary of Health and Human Services (HHS) to control a drug or other substance not previously scheduled, where the Secretary has recommended the drug or other substance be placed in schedule II, III, IV, or V, to be commenced not later than 120 days after
(continued...)
Spread the world
US Congress 113th Congress
Sunscreen Innovation Act [HB-4250]
Sunscreen Innovation Act - (Sec. 2) Amends the Federal Food, Drug, and Cosmetic Act to establish a process for the review and approval of over-the-counter (OTC) sunscreen active ingredients. Allows any person to request that the Secretary of Health and Human Services (HHS) determine whether an OTC sunscreen active ingredient or combination of ingredients is safe and effective. Requires the Secretary to review any request regarding a sunscreen active ingredient or combination of ingredients that has been in use and that is not included in the stayed
(continued...)