Drug Safety, Medical Device, And Laboratory Regulation
US Congress 113th Congress
A resolution expressing the sense of the Senate that the Food and Drug Administration should encourage the use of abuse-deterrent formulations of drugs. [SR-97]
Expresses the sense of the Senate that the Food and Drug Administration (FDA) should exercise its acknowledged authority to: (1) refuse to approve generic versions of non-abuse-deterrent opioid products that have been replaced in the market with abuse-deterrent formulations recognized by FDA as effective, and (2) require generic versions of abuse-deterrent opioid products to be formulated with comparable abuse-deterrent features.
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Pharmaceutical Quality, Security, and Accountability Act [S.959]
Pharmaceutical Quality, Security, and Accountability Act - Title I: Human Drug Compounding - Pharmaceutical Compounding Quality and Accountability Act - (Sec. 102) Amends the Federal Food, Drug, and Cosmetic Act (FFDCA) to expand the regulation of compounded drugs. Subjects a compounded drug to all FFDCA requirements applicable to new drugs. Sets forth exceptions from new drug requirements, biological product requirements, labeling requirements, and good manufacturing practice requirements for a drug that: (1) is compounded by a traditional compounder,
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Drug Supply Chain Security Act [S.957]
Drug Supply Chain Security Act - Amends the Federal Food, Drug, and Cosmetic Act to establish requirements to facilitate the tracing of drug products through the pharmaceutical supply distribution chain. Provides requirements of standards for the exchange of transaction documentation, to be established by the Secretary. Requires the Secretary to establish processes to: (1) provide waivers of requirements, including for undue economic hardship or emergency medical reasons; (2) provide exceptions to requirements relating to product identifiers if
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Ensuring Access to Quality Complex Rehabilitation Technology Act of 2013 [S.948]
Ensuring Access to Quality Complex Rehabilitation Technology Act of 2013 - Amends title XVIII (Medicare) of the Social Security Act to cover, as medical and other health services, complex rehabilitation technology items designed and configured for a specific qualified individual to meet that individual's unique: (1) medical, physical, and functional needs related to a medical condition; and (2) capacities for basic activities of daily living (ADLs) and instrumental ADLs. Directs the Secretary of Health and Human Services (HHS) to: (1) designate
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Antimicrobial Data Collection Act [S.895]
Antimicrobial Data Collection Act - Requires the Secretary of Health and Human Services (HHS), acting through the Commissioner of Food and Drugs (FDA), to develop a research program to study the relationship between the sales, distribution, and end-use practices of animal drugs containing an antimicrobial active ingredient in food-producing animals and antimicrobial resistance trends. Requires the Secretary to analyze data from the program to determine the data's contribution to studying antimicrobial resistance and establishing an antimicrobial
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Animal and Public Health Protection Act [S.859]
Animal and Public Health Protection Act - Amends the Farm Security and Rural Investment Act of 2002 to direct the Secretary of Agriculture (USDA) to offer to enter into contracts, grants, or cooperative agreements with eligible laboratories to: (1) detect emerging or existing threats to animal health and support the protection of public health, the environment, and the agricultural economy; (2) provide the capability for standardized test procedures, laboratory biosafety and biosecurity, interconnected electronic data reporting, and emergency preparedness
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Cody Miller Initiative for Safer Prescriptions Act [S.752]
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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PACT Act [S.644]
Preventing Abuse of Cough Treatments Act of 2013 or PACT Act - Amends the Federal Food, Drug, and Cosmetic Act to prohibit the sale or offering for sale of a drug containing dextromethorphan, and not subject to practitioner supervision requirements, to an individual under age 18, except if the sale is made: (1) pursuant to a validly issued prescription; or (2) to an individual who provides proof of being actively enrolled in the military, including a valid military identification card. Imposes civil monetary penalties that escalate upon repeated
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Medical Innovation Prize Fund Act [S.627]
Medical Innovation Prize Fund Act - Denies any person the exclusive right to manufacture, distribute, sell, or use in interstate commerce a drug, a biological product, or a drug or biological product manufacturing process, including the exclusive right to rely on health registration data or the 30-month stay-of-effectiveness period for Orange Book patents. Prescribes remuneration, in the form of prize payments from a Fund for Medical Innovation Prizes, in lieu of such market exclusivity. Establishes: (1) the Fund for Medical Innovation Prizes; and
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Prize Fund for HIV/AIDS Act [S.626]
Prize Fund for HIV/AIDS Act - Denies any person the exclusive right to manufacture, distribute, sell, or use in interstate commerce a qualifying treatment for HIV/AIDS, or to a manufacturing process for such a treatment, including the exclusive right to rely on health registration data or the 30-month stay-of-effectiveness period for Orange Book patents. Prescribes remuneration, in the form of prize payments from a Prize Fund for HIV/AIDS, in lieu of such market exclusivity. Exempts from this elimination of exclusive rights any dual use product
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Animal Drug and Animal Generic Drug User Fee Reauthorization Act of 2013 [S.622]
Animal Drug and Animal Generic Drug User Fee Reauthorization Act of 2013 - Title I: Fees Relating to Animal Drugs - 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
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Fair And Immediate Release of Generic Drugs Act [S.504]
Fair And Immediate Release of Generic Drugs Act or FAIR Generics Act - Amends the Federal Food, Drug, and Cosmetic Act (FFDCA) to revise the definition of “first applicant” for purposes of the 180-day exclusivity period given to first applicants to file an abbreviated new drug application (generic drug). Makes applicants for a generic drug eligible for the exclusivity period only if they have not entered into a disqualifying agreement (an agreement between a generic drug applicant and the holder of the application for the listed drug [brand name
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MCAP Act [S.44]
Medical Care Access Protection Act of 2013 or MCAP Act - Prescribes requirements for lawsuits for health care liability claims related to the provision of health care services. Sets a statute of limitations of three years after the date of manifestation of injury or one year after the claimant discovers the injury, with certain exceptions. Requires a court to impose sanctions for the filing of frivolous lawsuits. Limits noneconomic damages to $250,000 from the provider or health care institution, but no more than $500,000 from multiple health care
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Paul D. Wellstone Muscular Dystrophy Community Assistance, Research and Education Amendments of 2014 [S.315]
Paul D. Wellstone Muscular Dystrophy Community Assistance, Research and Education Amendments of 2014 - (Sec. 2) Amends the Public Health Service Act to revise the muscular dystrophy research program of the National Institutes of Health (NIH). Expands the range of forms of muscular dystrophy included within the program. Requires the research conducted through Paul D. Wellstone Muscular Dystrophy Cooperative Research Centers to include cardiac and pulmonary function research. Requires the Director of NIH to ensure the sharing of data between such
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Dormant Therapies Act of 2014 [S.3004]
Dormant Therapies Act of 2014
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PATH Act [S.2996]
PATH Act
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Adding Ebola to the FDA Priority Review Voucher Program Act [S.2917]
Adding Ebola to the FDA Priority Review Voucher Program Act - (Sec. 2) 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
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Microbead-Free Waters Act of 2014 [S.2902]
Microbead-Free Waters Act of 2014 - Amends the Federal Food, Drug, and Cosmetic Act to prohibit the distribution of a cosmetic that contains synthetic plastic microbeads beginning on January 1, 2018.
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Regulatory Transparency, Patient Access, and Effective Drug Enforcement Act of 2014 [S.2862]
Regulatory Transparency, Patient Access, and Effective Drug Enforcement Act of 2014
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Preserving Religious Freedom and a Woman's Access to Contraception Act [S.2605]
Preserving Religious Freedom and a Woman's Access to Contraception Act - Prohibits employers from restricting employees from purchasing any drug or medical device regulated by the Food and Drug Administration (FDA). Repeals sections of the Patient Protection and Affordable Care Act and the Health Care and Education Reconciliation Act of 2010 to: (1) allow health savings accounts, medical savings accounts, and health flexible spending accounts to be used to pay for non-prescription drugs; and (2) remove the annual limit for salary reduction contributions
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