Drug Safety, Medical Device, And Laboratory Regulation
US Congress 113th Congress
Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act, 2014 [HB-2410]
Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act, 2014 - Title I: Agricultural Programs - Appropriates FY2014 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;
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Sponsored by: Rep. Robert Aderholt
Rule H. Res. 274 Passed House. on 06/26/2013
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Health Care Innovation and Marketplace Technologies Act of 2013 [HB-2363]
Health Care Innovation and Marketplace Technologies Act of 2013 - Amends the Internal Revenue Code to allow a medical care provider to deduct from gross income the amount paid or incurred for qualified health information technology placed in service during the taxable year. Amends the Small Business Act to authorize the Administrator of the Small Business Administration (SBA) to guarantee up to 90% of the amount of a loan, up to specified loan amounts, to a small business health professional to be used for the acquisition and installation of health
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Sponsored by: Rep. Michael Honda
Referred To The Subcommittee On Health. on 06/14/2013
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Clinical Trial Cancer Mission 2020 Act [HB-2301]
Clinical Trial Cancer Mission 2020 Act - Revises clinical trial registry data bank provisions of the Public Health Service Act to: (1) include a device or drug clinical trial whether or not it results in a positive or negative outcome, and (2) subject clinical trials funded by the Department of Defense (DOD) to requirements to certify information submissions to the Director of the National Institutes of Health (NIH). Restricts funding for a grantee and makes the grantee liable to the United States for repayment of any grant amount provided, if the
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Sponsored by: Rep. Louise Slaughter
Referred To The Subcommittee On Health. on 06/07/2013
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VALID Compounding Act [HB-2186]
Verifying Authority and Legality In Drug Compounding Act of 2013 or VALID Compounding Act - Amends the Federal Food, Drug, and Cosmetic Act with respect to the regulation of compounding drugs. Requires the Secretary of Health and Human Services (HHS) to develop and maintain a list of bulk substances from which drug products may be compounded that specifies any limitation on compounding of the substance and the particular medical need that is met by placing such substance on the list. Requires the Secretary to receive and consider petitions from
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Sponsored by: Sen. Edward Markey
Referred To The Subcommittee On Health. on 05/24/2013
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Patient Choice Act of 2013 [HB-2090]
Patient Choice Act of 2013 - Amends the Federal Food, Drug, and Cosmetic Act to authorize provisional approval of fast track products determined by the Secretary of Health and Human Services (HHS) to be adequately safe. Treats provisional approval in the same manner as approval of a drug, except that provisional approval is subject to requirements related to informed consent and continued pursuit of safety and efficacy data for purposes of gaining approval for the drug. Defines the term “adequately safe” to mean that: (1) for at least one population,
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Sponsored by: Rep. H. Morgan Griffith
Referred To The Subcommittee On Health. on 05/24/2013
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TEST Act [HB-2031]
Trial and Experimental Studies Transparency Act of 2012 [sic] or TEST Act - Amends the Public Health Service Act to expand the clinical trials that must be reported to the clinical trial registry data bank to include: (1) any interventional study of a drug, device, or biological product conducted outside of the United States the results of which are submitted to the Secretary of Health and Human Services (HHS) as support for approval of an application; and (2) postmarket surveillance of a class II or class III device that involves data collection
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Sponsored by: Rep. Janice Schakowsky
Referred To The Subcommittee On Health. on 05/17/2013
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Gluten in Medicine Disclosure Act of 2013 [HB-2003]
Gluten in Medicine Disclosure Act of 2013 - Amends the Federal Food, Drug, and Cosmetic Act to deem to be misbranded any drug intended for human use that contains an ingredient (other than a polyol) that constitutes or is derived from a grain or starch-containing ingredient and whose label fails to include a parenthetical statement identifying the source of the ingredient so constituted or derived.
Sponsored by: Rep. Raul Grijalva
Referred To The Subcommittee On Health. on 05/17/2013
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Gray Market Drug Reform and Transparency Act of 2013 [HB-1958]
Gray Market Drug Reform and Transparency Act of 2013 - Amends the Federal Food, Drug, and Cosmetic Act to: (1) make it a prohibited act and a misbranding for a wholesale distributor of prescription drugs to purchase or receive a prescription drug from a pharmacy or a pharmacist, (2) require annual reporting by wholesale distributors of prescription drugs, (3) require the Secretary of Health and Human Services (HHS) to establish and maintain a national database of information reported by wholesale distributors of prescription drugs and to require
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Sponsored by: Rep. Elijah Cummings
Referred To The Subcommittee On Health. on 05/17/2013
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Safeguarding America's Pharmaceuticals Act of 2013 [HB-1919]
Safeguarding America's Pharmaceuticals Act of 2013 - (Sec. 2) Amends the Federal Food, Drug, and Cosmetic Act to establish requirements to facilitate the tracing of drug products through the pharmaceutical supply distribution chain. Requires the Secretary of Health and Human Services (HHS) to establish standards for the exchange of transaction information. Requires the Secretary to establish processes to: (1) provide waivers of requirements for undue economic hardship or emergency medical reasons; (2) provide waivers of requirements relating to
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Sponsored by: Rep. David Valadao
Received In The Senate And Read Twice And Referred To The Committee On Health, Education, Labor, And Pensions. on 06/04/2013
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Foreign Manufacturers Legal Accountability Act of 2013 [HB-1910]
Foreign Manufacturers Legal Accountability Act of 2013 - Expresses the sense of Congress with respect to jurisdiction of courts in the United States over foreign manufacturers that import products into the United States. Directs the Food and Drug Administration (FDA) (with respect to drugs, devices, cosmetics, and biological products), the Consumer Product Safety Commission (CPSC) (with respect to consumer products), and the Environmental Protection Agency (EPA) (with respect to chemical substances, new chemical substances, and pesticides) to require
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Sponsored by: Rep. Barbara Lee
Referred To The Subcommittee On Trade. on 06/03/2013
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National Commission on Federal Marijuana Policy Act of 2013 [HB-1635]
National Commission on Federal Marijuana Policy Act of 2013 - Establishes the National Commission on Federal Marijuana Policy to undertake a comprehensive review of current policies of the federal government toward marijuana in light of the growing number of states in which marijuana is legal for medicinal or personal use. Requires such review to include: (1) how federal policy should interact with state laws that make marijuana legal for such use; (2) the cost of the prohibition and potential regulation of marijuana and the potential revenue generated
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Sponsored by: Rep. Raul Grijalva
Referred To The Subcommittee On Crime, Terrorism, Homeland Security, And Investigations. on 04/30/2013
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Cody Miller Initiative for Safer Prescriptions Act [HB-1608]
Cody Miller Initiative for Safer Prescriptions Act - Amends the Federal Food, Drug, and Cosmetic Act to direct the Secretary of Health and Human Services (HHS) to promulgate regulations regarding the authorship, content, format, and dissemination requirements for patient medication information (PMI) for prescription drugs. Requires such regulations to require the PMI for such a drug: (1) to be scientifically accurate and to be based on the approved professional labeling and authoritative, peer-reviewed literature; and (2) to include plain language
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Sponsored by: Rep. William Owens
Referred To The Subcommittee On Health. on 04/19/2013
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Animal Generic Drug User Fee Amendments of 2013 [HB-1408]
Animal Generic Drug User Fee Amendments of 2013 - Amends the Federal Food, Drug, and Cosmetic Act to extend for FY2014-FY2018 the authority of the Food and Drug Administration (FDA) to collect generic animal drug user fees, specifically abbreviated application fees for generic new animal drugs, generic new animal drug product fees, and generic new animal drug sponsor fees. Subjects generic animal drug applications to a fee 50% of the amount of the normal fee if the application is for an animal drug which contains more than one active ingredient,
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Sponsored by: Rep. Frank Pallone
Referred To The Subcommittee On Health. on 04/12/2013
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Animal Drug User Fee Amendments of 2013 [HB-1407]
Title I: Animal Drug User Fee Amendments - Animal Drug User Fee Amendments of 2013 - (Sec. 103) Amends the Federal Food, Drug, and Cosmetic Act to extend for FY2014-FY2018 the authority of the Food and Drug Administration (FDA) to collect animal drug user fees, specifically new animal drug application or supplemental animal drug application fees, animal drug product fees, animal drug establishment fees, and animal drug sponsor fees. Revises the due date for annual user fees to the later of January 31 of each year or the first business day after
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Sponsored by: Rep. Frank Pallone
Reported (amended) By The Committee On Energy And Commerce. H. Rept. 113-188. on 08/02/2013
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Stop Oxy Abuse Act of 2013 [HB-1366]
Stop Oxy Abuse Act of 2013 - Directs the Commissioner of Food and Drugs (FDA), within 90 days, to take such actions as may be necessary to modify the approval of, and limit any subsequent approval of, any drug containing controlled-release oxycodone hychloride to use for the relief of severe-only pain instead of moderate-to-severe pain.
Sponsored by: Rep. Janice Schakowsky
Referred To The Subcommittee On Health. on 03/22/2013
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Preservation of Antibiotics for Medical Treatment Act of 2013 [HB-1150]
Preservation of Antibiotics for Medical Treatment Act of 2013 - Amends the Federal Food, Drug, and Cosmetic Act to require an applicant for approval of a new animal drug that is a medically important antimicrobial to demonstrate that there is a reasonable certainty of no harm to human health due to the development of antimicrobial resistance attributable to the nontherapeutic use of the drug. Requires the Secretary of Health and Human Services (HHS) to refuse approval if the applicant fails to make such a demonstration. Defines “medically important
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Sponsored by: Rep. Raul Grijalva
Referred To The Subcommittee On Health. on 03/15/2013
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Commitment to Defeat the Virus and Keep America Healthy Act [HB-14]
Provides funding for various public health programs and activities and revises multiple provisions, including within the tax code, to respond to COVID-19 (i.e., coronavirus disease 2019) and otherwise address health outcomes. The bill specifically makes changes to support pharmaceutical manufacturing and supply chains; prevent diversion of controlled substances; increase access to telehealth services under Medicare; and expand various public health programs to address health disparities, maternal and infant health, and behavioral health.
Sponsored by: Rep. Gus Bilirakis
Referred To The Subcommittee On Economic Development, Public Buildings, And Emergency Management. on 11/02/2020
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Accelerating Access to Critical Therapies for ALS Act [S.4867]
Establishes grant programs to address neurodegenerative diseases, such as amyotrophic lateral sclerosis (also known as ALS or Lou Gehrig's disease), and contains other related provisions. The Department of Health and Human Services (HHS) shall award grants to eligible entities to support research on and facilitate access to investigational drugs that diagnose or treat ALS. The Food and Drug Administration shall award grants to public and private entities to cover the costs of research and development of drugs that diagnose or treat ALS and other
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Sponsored by: Sen. Dianne Feinstein
Read Twice And Referred To The Committee On Health, Education, Labor, And Pensions. on 10/26/2020
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Accelerating Access to Critical Therapies for ALS Act [HB-8662]
Establishes grant programs to address neurodegenerative diseases, such as amyotrophic lateral sclerosis (also known as ALS or Lou Gehrig's disease), and contains other related provisions. The Department of Health and Human Services (HHS) shall award grants to eligible entities to support research on and facilitate access to investigational drugs that diagnose or treat ALS. The Food and Drug Administration shall award grants to public and private entities to cover the costs of research and development of drugs that diagnose or treat ALS and other
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Sponsored by: Rep. Alexander Mooney
Introduced In House on 10/23/2020
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The Heroes Act [S.4800]
A bill to provide Coronavirus relief.
Sponsored by: Sen. Charles Schumer
Read The Second Time. Placed On Senate Legislative Calendar Under General Orders. Calendar No. 581. on 11/09/2020