Authors : Darrow JJ; Program On Regulation, Therapeutics, And Law (PORTAL), Division of Pharmacoepidemiology and Pharmacoeconomics, Department of Medicine, Brigham and Women's Hospital, Harvard Medical School, Boston, Massachusetts.; Avorn J

Subjects: Government Regulation* ; United States Food and Drug Administration*; Drug Approval/Drug Approval/Drug Approval/*legislation & jurisprudence

Source: JAMA [JAMA] 2020 Jan 14; Vol. 323 (2), pp. 164-176.Publisher: American Medical Association Country of Publication: United States NLM ID: 7501160

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Assessment of the real-world safety profile of vedolizumab using the United States Food and Drug Administration adverse event reporting system.

Authors : Cross RK; University of Maryland School of Medicine, Baltimore, Maryland, United States of America.; Chiorean M

Subjects: Adverse Drug Reaction Reporting Systems* ; United States Food and Drug Administration*; Antibodies, Monoclonal, Humanized/Antibodies, Monoclonal, Humanized/Antibodies, Monoclonal, Humanized/*adverse effects

Source: Plos One [PLoS One] 2019 Dec 04; Vol. 14 (12), pp. e0225572. Date of Electronic Publication: 20191204 (Print Publication: 2019).Publisher: Public Library of Science Country of Publication: United States NLM ID: 101285081

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Association Between Medicare and FDA Policies and Prior Authorization Requirements for Buprenorphine Products in Medicare Part D Plans.

Authors : Mark TL; RTI International, Rockville, Maryland.; Parish W

Subjects: Government Regulation* ; Insurance Coverage* ; Medicare Part D*/Medicare Part D*/Medicare Part D*/legislation & jurisprudence

Source: JAMA [JAMA] 2019 Jul 09; Vol. 322 (2), pp. 166-167.Publisher: American Medical Association Country of Publication: United States NLM ID: 7501160

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Development of Treatments for Localized Prostate Cancer in Patients Eligible for Active Surveillance: U.S. Food and Drug Administration Oncology Center of Excellence Public Workshop.

Authors : Weinstock C; United States Food and Drug Administration, Silver Spring, Maryland.; Suzman D

Subjects: Clinical Trials as Topic* ; Research Design* ; United States Food and Drug Administration*

Source: The Journal Of Urology [J Urol] 2020 Jan; Vol. 203 (1), pp. 115-119. Date of Electronic Publication: 2019 Sep 10.Publisher: Wolters Kluwer Country of Publication: United States NLM ID: 0376374 Publication Model:

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Pentagon's social science research faces threat.

Authors : Mervis J

Subjects: Cultural Competency* ; United States Department of Defense*; Social Sciences/Social Sciences/Social Sciences/*economics

Source: Science (New York, N.Y.) [Science] 2020 Mar 06; Vol. 367 (6482), pp. 1065.Publisher: American Association for the Advancement of Science Country of Publication: United States NLM ID:

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Joint statement on EPA proposed rule and public availability of data (2019).

Authors : Thorp HH; Editor-in-Chief, Science family of journals, Washington, District of Columbia, United States of America.; Skipper M

Subjects: Information Dissemination/Information Dissemination/Information Dissemination/*ethics ; United States Environmental Protection Agency/United States Environmental Protection Agency/United States Environmental Protection Agency/*ethics ; United States Environmental Protection Agency/United States Environmental Protection Agency/United States Environmental Protection Agency/*legislation & jurisprudence

Source: Plos Medicine [PLoS Med] 2019 Nov 26; Vol. 16 (11), pp. e1003014. Date of Electronic Publication: 20191126 (Print Publication: 2019).Publisher: Public Library of Science Country of Publication: United States NLM ID: 101231360

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Lead exposures in older children (males and females 7-17 years), women of childbearing age (females 16-49 years) and adults (males and females 18+ years): FDA total diet study 2014-16.

Authors : Gavelek A; US Food and Drug Administration (FDA), Center for Food Safety and Applied, Nutrition (CFSAN), College Park, MD, USA.; Spungen J

Subjects: Diet Surveys* ; United States Food and Drug Administration*; Diet/Diet/Diet/*statistics & numerical data

Source: Food Additives & Contaminants. Part A, Chemistry, Analysis, Control, Exposure & Risk Assessment [Food Addit Contam Part A Chem Anal Control Expo Risk Assess] 2020 Jan; Vol. 37 (1), pp. Publisher: Informa Healthcare Country of Publication: England NLM ID: 101485040 Publication Model: Print-Electronic Cited Medium: Internet ISSN:

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The Environmental Protection Agency's Use of Community Involvement to Engage Communities at Superfund Sites.

Authors : Zaragoza LJ; Environmental Protection Agency, Office of Superfund Remediation and Technology Innovation, 1200 Pennsylvania Ave NW, 5204P, Washington, DC 20460, USA. .

Subjects: Hazardous Waste Sites*; Community Participation/Community Participation/Community Participation/*methods ; Environmental Restoration and Remediation/Environmental Restoration and Remediation/Environmental Restoration and Remediation/*methods

Source: International Journal Of Environmental Research And Public Health [Int J Environ Res Public Health] 2019 Oct 29; Vol. 16 (21). Date of Electronic Publication: 2019 Oct 29.Publisher: MDPI Country of Publication: Switzerland NLM ID: 101238455 Publication Model: Electronic Cited Medium: Internet ISSN: 1660-4601

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Effectiveness and safety of direct oral anticoagulants compared to warfarin in treatment naïve non-valvular atrial fibrillation patients in the US Department of defense population.

Authors : Gupta K; Bristol-Myers Squibb, Lawrenceville, NJ, USA.; Trocio J

Subjects: United States Department of Defense*; Anticoagulants/Anticoagulants/Anticoagulants/*administration & dosage ; Atrial Fibrillation/Atrial Fibrillation/Atrial Fibrillation/*drug therapy

Source: BMC Cardiovascular Disorders [BMC Cardiovasc Disord] 2019 Jun 13; Vol. 19 (1), pp. 142. Date of Electronic Publication: 2019 Jun 13.Publisher: BioMed Central Country of Publication: England NLM ID: 100968539 Publication Model: Electronic Cited Medium: Internet ISSN: 1471-2261

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Communication of Nonefficacy Benefits of New Drugs Approved on the Basis of Noninferiority Trials Alone: Cohort Study of FDA and Sponsor Communication, 2011-2017.

Authors : Doshi P; Department of Pharmaceutical Health Services Research, University of Maryland School of Pharmacy, Baltimore, Maryland.; Spence O

Subjects: Communication* ; Drug Approval* ; Drug Industry*

Source: JAMA Internal Medicine [JAMA Intern Med] 2019 May 01; Vol. 179 (5), pp. 719-721.Publisher: American Medical Association Country of Publication: United States NLM ID: 101589534

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