Drug Safety, Medical Device, And Laboratory Regulation
US Congress 117th Congress
United States Anti-Doping Agency Reauthorization Act of 2021 [HB-172]
To reauthorize the United States Anti-Doping Agency, and for other purposes.
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Enhancing the Security of the U.S. Pharmaceutical Supply Chain Act of 2020 [HB-8987]
To amend the Public Health Service Act to incentivize the manufacture of certain medicines in the United States and to enhance the security of the United States pharmaceutical supply chain, and for other purposes.
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US Congress 116th Congress
COVID–19 Vaccine Awareness Support Act of 2020 [HB-8966]
Requires the Centers for Disease Control and Prevention to award grants to state, tribal, territorial, and local health departments or nonprofits to disseminate information about COVID-19 (i.e., coronavirus disease 2019), including regarding the safety and efficacy of vaccines.
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US Congress 116th Congress
STAAR Act Strategies To Address Antibiotic Resistance Act [S.2304]
Expands various initiatives to address antibiotic resistance. The bill reestablishes the interagency Antimicrobial Resistance Task Force to coordinate and develop efforts addressing antibiotic resistance. The Department of Health and Human Services must encourage health care facilities to implement antimicrobial stewardship programs to evaluate and improve the use of antimicrobial drugs. The bill also requires the Centers for Disease Control and Prevention (CDC) to use the National Healthcare Safety Network to collect and report data about the usage
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COVID–19 Vaccine Awareness Support Act of 2020 [S.4958]
Requires the Centers for Disease Control and Prevention to award grants to state, tribal, territorial, and local health departments or nonprofits to disseminate information about COVID-19 (i.e., coronavirus disease 2019), including regarding the safety and efficacy of vaccines.
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US Congress 116th Congress
SAFE TO WORK Act Safeguarding America’s Frontline Employees To Offer Work Opportunities Required to Kickstart the Economy Act [HB-8832]
To lessen the burdens on interstate commerce by discouraging insubstantial lawsuits relating to COVID-19 while preserving the ability of individuals and businesses that have suffered real injury to obtain complete relief.
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US Congress 114th Congress
FDA Accountability for Public Safety Act [S.954]
FDA Accountability for Public Safety Act This bill requires the Commissioner of Food and Drugs to ensure that an advisory committee of the Center for Drug Evaluation and Research (CDER) of the Food and Drug Administration (FDA) evaluates each new drug application for an opioid (a drug with effects similar to opium, such as morphine) and issues a recommendation regarding approval of the drug. If the decision to approve the drug is inconsistent with the committee's recommendation, the Commissioner must make the final decision on approval. If the committee
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US Congress 114th Congress
Drug Free Commercial Driver Act of 2015 [S.806]
Drug Free Commercial Driver Act of 2015 (Sec. 2) This bill revises regulations that require motor carriers to conduct preemployment, reasonable suspicion, random, and post-accident testing of commercial motor vehicle operators for controlled substances or alcohol. Motor carriers may use hair testing as an acceptable alternative to urinalysis for detecting use of controlled substances by individuals, but only for preemployment testing and random testing. The Department of Transportation shall develop requirements for laboratories and testing procedures
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Increasing the Safety of Prescription Drug Use Act of 2015 [S.636]
Increasing the Safety of Prescription Drug Use Act of 2015 This bill amends the Public Health Service Act to revise, update, and expand state controlled substance monitoring programs, which ensure that prescription history information is accessible for investigations into drug diversion and errant prescribing and dispensing practices. A state's controlled substance monitoring program database must be interoperable with other states' databases and electronic health records, and must provide up-to-date patient information to practitioners. Practitioners
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Preventing Antibiotic Resistance Act of 2015 [S.621]
Preventing Antibiotic Resistance Act of 2015 This bill amends the Federal Food, Drug, and Cosmetic Act to require the Food and Drug Administration (FDA) to refuse a new animal drug application if the drug is a medically important antimicrobial (used to treat humans) and the applicant fails to demonstrate that the drug meets specified criteria for use in animals, including that: (1) the drug is effective, (2) the drug is targeted to animals at risk of developing a specific bacterial disease, (3) the drug has a defined duration of therapy, and (4)
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Co-Prescribing to Reduce Overdoses Act of 2016 Comprehensive Opioid Abuse Reduction Act of 2016 Examining Opioid Treatment Infrastructure Act of 2016 Good Samaritan Assessment Act of 2016 Improving Treatment for Pregnant and Postpartum Women Act of 2016 Infant Plan of Safe Care Improvement Act John Thomas Decker Act of 2016 Kingpin Designation Improvement Act of 2016 Lali's Law National All Schedules Prescription Electronic Reporting Reauthorization Act of 2015 Nurturing And Supporting Healthy Babies Act or the NAS Healthy Babies Act Opioid Program Evaluation Act or the OPEN Act Opioid Review Modernization Act of 2016 Opioid Use Disorder Treatment Expansion and Modernization Act Promoting Responsible Opioid Management and Incorporating Scientific Expertise Act or the Jason Simcakoski PROMISE Act Reducing Unused Medications Act of 2016 Veteran Emergency Medical Technician Support Act of 2016 Short Titles - Senate Short Titles as Passed Senate: Comprehensive Addiction and Recovery Act of 2016 [S.524]
Co-Prescribing to Reduce Overdoses Act of 2016 Comprehensive Opioid Abuse Reduction Act of 2016 Examining Opioid Treatment Infrastructure Act of 2016 Good Samaritan Assessment Act of 2016 Improving Treatment for Pregnant and Postpartum Women Act of 2016 Infant Plan of Safe Care Improvement Act John Thomas Decker Act of 2016 Kingpin Designation Improvement Act of 2016 Lali's Law National All Schedules Prescription Electronic Reporting Reauthorization Act of 2015 Nurturing And Supporting Healthy Babies Act or the NAS Healthy Babies Act Opioid Program
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Improving Regulatory Transparency for New Medical Therapies Act [S.481]
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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Traditional Cigar Manufacturing and Small Business Jobs Preservation Act of 2015 [S.441]
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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US Congress 114th Congress
Carl's Law [S.3298]
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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RACE for Children Act Research to Accelerate Cures and Equity for Children Act [S.3239]
RACE for Children Act Research to Accelerate Cures and Equity for Children Act
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Medical Innovation Act of 2015 [S.320]
Medical Innovation Act of 2015 This bill amends the Public Health Service Act to require certain drug manufacturers to make payments to fund research supported by the Food and Drug Administration (FDA) and the National Institutes of Health (NIH). A drug manufacturer with over $1 billion in net income in a fiscal year that has entered into a settlement agreement in the previous five years with a federal agency regarding specified violations must pay 1% of its net income to the Department of Health and Human Services (HHS) for each of its covered
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US Congress 114th Congress
STAAR Act Strategies to Address Antibiotic Resistance Act [S.3176]
STAAR Act Strategies to Address Antibiotic Resistance Act
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PRICED Act Price Relief, Innovation, and Competition for Essential Drugs Act [S.3094]
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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MEDS Act Marijuana Effective Drug Studies Act of 2016 [S.3077]
MEDS Act Marijuana Effective Drug Studies Act of 2016
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Addiction Prevention and Responsible Opioid Practices Act [S.3075]
Addiction Prevention and Responsible Opioid Practices Act