Drug Safety, Medical Device, And Laboratory Regulation
US Congress 115th Congress
Short on Competition Act [S.183]
Short on Competition Act This bill amends the Federal Food, Drug, and Cosmetic Act to require the Food and Drug Administration (FDA) to authorize importation of life-saving drugs for which there is, or is likely to be, a shortage. For a drug to be imported, the drug's manufacturer must intend to seek FDA approval of the drug as a generic drug. The FDA may deny importation of a drug for reasons related to safety or effectiveness. Drugs in noncompetitive markets must be treated as being in a shortage for purposes of this bill and for purposes of expedited
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Cosmetic Modernization Amendments of 2017 [HB-575]
Cosmetic Modernization Amendments of 2017 This bill amends the Federal Food, Drug, and Cosmetic Act to set forth provisions governing the regulation of cosmetics by the Food and Drug Administration (FDA), including requiring the registration of manufacturing establishments and the submission of a cosmetic and ingredient statement for each cosmetic. The FDA must publish a list of registered establishments and a list of cosmetics and their ingredients. Cosmetic manufacturers, packers, and distributors must report to the FDA any serious and unexpected
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Traditional Cigar Manufacturing and Small Business Jobs Preservation Act of 2017 [HB-564]
Traditional Cigar Manufacturing and Small Business Jobs Preservation Act of 2017 This bill 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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Allowing Greater Access to Safe and Effective Contraception Act [HB-421]
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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Safe and Affordable Drugs from Canada Act of 2017 [S.92]
Safe and Affordable Drugs from Canada Act of 2017 This bill amends the Federal Food, Drug, and Cosmetic Act (FFDCA) to require the Department of Health and Human Services (HHS) to promulgate regulations within 185 days permitting individuals to import a prescription drug purchased from an approved Canadian pharmacy that: is dispensed by a pharmacist licensed in Canada; 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;
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Allowing Greater Access to Safe and Effective Contraception Act [S.93]
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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Safe and Affordable Drugs from Canada Act of 2017 [S.64]
Safe and Affordable Drugs from Canada Act of 2017 This bill 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 Canadian pharmacy that: is dispensed by a pharmacist licensed in Canada; 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;
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HIRE Vets Act Honoring Investments in Recruiting and Employing American Military Veterans Act of 2017 [HB-244]
HIRE Vets Act Honoring Investments in Recruiting and Employing American Military Veterans Act of 2017 (Sec. 3) Provides that references to "this Act" included in any division of this bill refer only to the provisions of the division unless the bill expressly provides otherwise. (Sec. 4) Provides that the explanatory statement printed in the Congressional Record regarding this bill has the same effect as a joint explanatory statement of a committee of conference. (Sec. 5) Provides that the sums in this bill are appropriated for FY2017. (Sec. 6) Provides
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Biological Implant Tracking and Veteran Safety Act of 2017 [S.23]
Biological Implant Tracking and Veteran Safety Act of 2017 This bill directs the Department of Veterans Affairs (VA) to: 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 VA medical facilities; permit a vendor to use any of the accredited entities identified by the FDA as an issuing agency; implement (within 180 days after enactment of this bill) a compatible system
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Biological Implant Tracking and Veteran Safety Act of 2017 [HB-28]
Biological Implant Tracking and Veteran Safety Act of 2017 (Sec. 2) This bill directs the Department of Veterans Affairs (VA) 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 VA medical facilities; (2) permit a vendor to use any of the accredited entities identified by the FDA as an issuing agency; (3) implement (within 180 days after enactment of this bill)
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Quality Systems Certification Act of 2017 [HB-2483]
Quality Systems Certification Act of 2017 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
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AIM Act of 2017 Accelerating Innovation in Medicine Act of 2017 [HB-2503]
AIM Act of 2017 Accelerating Innovation in Medicine Act of 2017 This bill requires the Centers for Medicare & Medicaid Services (CMS) to develop, maintain, and make publicly available a list of medical devices that shall be voluntarily excluded from payment under the Medicare program. A Medicare beneficiary who consents to receive such a medical device shall be responsible for payment for the device. A manufacturer seeking to have a medical device included in the list must submit a request for inclusion to the CMS, in accordance with specified timelines.
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FDA Reauthorization Act of 2017 [HB-2430]
FDA Reauthorization Act of 2017 TITLE I--FEES RELATING TO DRUGS Prescription Drug User Fee Amendments of 2017 (Sec. 102) This bill amends the Federal Food, Drug, and Cosmetic Act to extend through FY2022 and revise Food and Drug Administration (FDA) user fees for brand name drugs. User fees are eliminated for supplemental new drug applications and drug manufacturing facilities. A prescription drug program fee replaces the prescription drug product fee. This annual fee is assessed on a new drug application holder for each approved drug for up to
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Menstrual Products Right to Know Act of 2017 [HB-2416]
Menstrual Products Right to Know Act of 2017 This bill requires menstrual products, such as menstrual cups, menstrual pads, tampons, and therapeutic vaginal douche apparatuses, to include a list of ingredients on the label.
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Personal Care Products Safety Act [S.1113]
Personal Care Products Safety Act This bill amends the Federal Food, Drug, and Cosmetic Act to require cosmetics companies to register their facilities with the Food and Drug Administration (FDA) and to submit to the FDA cosmetic ingredient statements that include the amounts of a cosmetic's ingredients. Companies must pay a facility registration fee based on their annual gross sales of cosmetics. The collected fees can only be used for cosmetic safety activities. If the FDA determines that a cosmetic has a reasonable probability of causing serious
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Pediatric Device Development Act [S.1093]
Pediatric Device Development Act
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Changing the Culture of the FDA Act [S.1077]
Changing the Culture of the FDA Act This bill requires the Food and Drug Administration to amend its mission statement to take responsibility for protecting the public health by considering the danger of addiction and overdose death when approving and regulating prescription opioid medications. (Opioid medications are drugs with effects similar to opium, such as certain pain medications.)
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FDA Accountability for Public Safety Act [S.1078]
FDA Accountability for Public Safety Act This bill amends the Comprehensive Addiction and Recovery Act of 2016 to expand the scope of the Food and Drug Administration (FDA) advisory committee to make recommendations regarding supplemental applications for opioids. Currently, the committee only makes recommendations on new drug applications. Only the Commissioner of Food and Drugs may approve a new drug application or supplement to an application for an opioid against the recommendation of the committee. If the Commissioner approves a drug against
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Drug Diversion and Counterfeit Crackdown Act of 2017 [HB-2376]
Drug Diversion and Counterfeit Crackdown Act of 2017
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Opioid Addiction Risk Transparency Act [S.1049]
Opioid Addiction Risk Transparency Act This bill amends the Federal Food, Drug, and Cosmetic Act to authorize the Food and Drug Administration to require a communication plan that is part of a medication's risk evaluation and mitigation strategy to include informing health care providers about the meaning of terms related to properties of the medication described in the labeling.