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The Department of Health and Human Services.
TLDR
This letter is in response to your two Citizen Petitions, requesting that the Food and Drug Administration (FDA or the Agency) require a cancer warning on cosmetic talc products.Abstract:
This letter is in response to your two Citizen Petitions dated November 17, 1994 and May 13, 2008, requesting that the Food and Drug Administration (FDA or the Agency) require a cancer warning on cosmetic talc products. Your 1994 Petition requests that all cosmetic talc bear labels with a warning such as \"Talcum powder causes cancer in laboratory animals. Frequent talc application in the female genital area increases the risk of ovarian cancer.\" Additionally, your 2008 Petition requests that cosmetic talcum powder products bear labels with a prominent warning such as: \"Frequent talc application in the female genital area is responsible for major risks of ovarian cancer.\" Further, both of your Petitions specifically request, pursuant to 21 CFR 1 0.30(h)(2), a hearing for you to present scientific evidence in support of this petition.read more
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Dietary pulses, satiety and food intake: A systematic review and meta‐analysis of acute feeding trials
Siying S. Li,Cyril W.C. Kendall,Russell J. de Souza,Viranda H. Jayalath,Adrian I. Cozma,Vanessa Ha,Arash Mirrahimi,Laura Chiavaroli,Livia S. A. Augustin,Sonia Blanco Mejia,Lawrence A. Leiter,Joseph Beyene,David J. A. Jenkins,John L. Sievenpiper +13 more
TL;DR: To assess the effect of dietary pulses (beans, peas, chickpeas, lentils) on acute satiety and second meal intake, a systematic review and meta‐analysis was conducted.
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Leveraging 3D Printing Capacity in Times of Crisis: Recommendations for COVID-19 Distributed Manufacturing for Medical Equipment Rapid Response.
Albert Manero,Peter A. Smith,Amanda Koontz,Matt Dombrowski,John Sparkman,Dominique Courbin,Albert Chi +6 more
TL;DR: To accommodate future surges, hospitals and municipalities should develop capacity for short-run custom production, enabling them to validate new designs and rapidly increase access to vetted equipment and critical network sharing with community distributed manufacturers and partners.
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Cost effectiveness of pharmacogenetic testing for uridine diphosphate glucuronosyltransferase 1A1 before irinotecan administration for metastatic colorectal cancer
TL;DR: The objective of this study was to examine the cost effectiveness of using a pharmacogenetic test for uridine diphosphate glycosyltransferase 1A1*28 (UGT1A 1*28) variant homozygosity before administering irinotecan to patients with metastatic colorectal cancer.
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Punishing pregnant drug-using women: defying law, medicine, and common sense
Jeanne Flavin,JD Lynn M Paltrow +1 more
TL;DR: The authors highlight the inherent unfairness of a system that expects low-income and drug-dependent pregnant women to provide their fetuses with the health care and safety that these women themselves are not provided and have not been guaranteed.
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Oral Direct Factor Xa Inhibitors Versus Low-Molecular-Weight Heparin to Prevent Venous Thromboembolism in Patients Undergoing Total Hip or Knee Replacement: A Systematic Review and Meta-analysis
Ignacio Neumann,Gabriel Rada,Juan Carlos Claro,Alonso Carrasco-Labra,Kristian Thorlund,Elie A. Akl,Shannon M. Bates,Gordon H. Guyatt +7 more
TL;DR: Compared with LMWH, lower doses of oral factor Xa inhibitors can achieve a small absolute risk reduction in symptomatic deep venous thrombosis without increasing bleeding.
References
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An herbal supplement containing Ma Huang-Guarana for weight loss: a randomized, double-blind trial
TL;DR: This herbal mixture of Ma Huang and Guarana effectively promoted short-term weight and fat loss and safety with long-term use requires further investigation.
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Historical background of clinical trials involving women and minorities
TL;DR: A historical context for the difficult ethical and clinical issues associated with the inclusion of women and members of minority groups in clinical research is provided.
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Reported Complications of Silicone Gel Breast Implants: An Epidemiologic Review
Barbara G. Silverman,S. L. Brown,Roselie A. Bright,Ronald G. Kaczmarek,J B Arrowsmith-Lowe,D A Kessler +5 more
TL;DR: This review presents an overview of the most common adverse outcomes that have been reported with silicone gel breast implants and focuses on silicone breast implants rather than saline-filled implants, which have been the focus of the greatest health concerns.
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Serum levels of TCDD and dioxin-like chemicals in Rhesus monkeys chronically exposed to dioxin: correlation of increased serum PCB levels with endometriosis
Sherry E. Rier,Wayman E. Turner,Dan C. Martin,Richard W Morris,George W. Lucier,George C. Clark +5 more
TL;DR: It is demonstrated that the serum levels of TCDD and specific dioxin-like PHAH congeners were increased in TCDd-treated animals with endometriosis 13 years after the T CDD exposure, and the severity of disease correlated with the serum concentration of 3,3',4,4'-TCB.
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Aiding troubled employees: The prevalence, cost, and characteristics of employee assistance programs in the United States
Tyler Hartwell,Paul D. Steele,Michael T. French,Frank J. Potter,Nathaniel F. Rodman,Gary A. Zarkin +5 more
TL;DR: EAPs are becoming a more prevalent point of access to health care for workers with personal problems such as substance abuse, family problems, or emotional distress by worksite size, industry, and census region.