The Experts below are selected from a list of 102 Experts worldwide ranked by ideXlab platform

Erika Lietzan - One of the best experts on this subject based on the ideXlab platform.

  • antitrust abuses and the fda approval Process Statement before the committee on the judiciary s subcommittee on regulatory reform commercial and antitrust law u s house of representatives
    Social Science Research Network, 2017
    Co-Authors: Erika Lietzan
    Abstract:

    Various scholars and policymakers have voiced concern over the years that pharmaceutical companies often operate in ways that are inconsistent with norms of fair competition and may violate antitrust law — in particular that, despite complying with the regulatory framework and the intellectual property framework, these companies invoke or employ these frameworks inappropriately. I was asked by subcommittee staff to provide my perspective on three aspects of the regulatory paradigm of particular interest: citizen petitions, use and distribution restrictions, and FDA’s unapproved drugs initiative. The written Statement concludes with a page of concrete recommendations, which reflect four core values. The first value is the public health mandate embodied in FDA’s statutory mission: promotion of the public health through prompt and efficient review of clinical research and timely appropriate action on marketing of regulated products, and protection of the public health by ensuring that drugs are safe and effective. The second value is the open government principle embodied in the petition clause of the First Amendment, the agency’s mission Statement, the APA, and other federal statutes: transparency, access, and accountability. The third value is the importance of the patent property right to continued innovation in medicine, and the final value is the importance of evidence-based policymaking, both in the legislature and in administrative agencies.

Gerald A Evans - One of the best experts on this subject based on the ideXlab platform.

  • Guidance on The Use of Antiviral Drugs for Influenza in Acute Care Facilities in Canada, 2014-2015
    Canadian Journal of Infectious Diseases & Medical Microbiology, 2020
    Co-Authors: H Grant Stiver, Gerald A Evans, Fred Y. Aoki, Upton Allen, Michel Laverdière
    Abstract:

    A. Process Statement The development of this updated guidance arose in November 2014 from information provided by the Public Health Agency of Canada regarding early data indicating a mismatch of the influenza vaccine H3N2 component to an emerging H3N2 seasonal strain. This created a need to update recommendations for the use of antiviral drugs for this year’s seasonal influenza. The concept was then approved by Association of Medical Microbiology and Infectious Disease (AMMI) Canada. A first draft was cowritten by all the authors (HGS, FYA, UDA, GAE and ML). Subsequently, all the authors reviewed, revised and approved the document before a further review from the AMMI Canada Guidelines Committee and the Infectious Diseases and Immunization Committee of the Canadian Paediatric Society. AMMI Canada approved the final document before submission to the Journal for publication.

  • The Use of Antiviral Drugs for Influenza: A Foundation Document for Practitioners
    Canadian Journal of Infectious Diseases & Medical Microbiology, 2020
    Co-Authors: Upton D Allen Mbbs, H Grant Stiver, Gerald A Evans
    Abstract:

    1C INDEX I. PURPOSE II. Process Statement III. GRADING OF RECOMMENDATIONS IV. THE DISEASE A. Influenza viruses B. Clinical aspects C. Clinical diagnosis of influenza illness V. TREATMENT OF INFLUENZA ILLNESS A. Antiviral drugs including off-label use B. Benefits of antiviral treatment C. Considerations in selecting treatments 1. Severity of illness 2. Presence of risk factors or co-morbid medical conditions 3. Interval between onset of illness and initiation of antiviral therapy 4. Likely influenza type(s) causing infection D. Treatment of children E. Treatment of immunocompromised patients F. Treatment of patients with renal impairment G. Treatment of pregnant patients VI. RECOMMENDATIONS FOR TREATMENT A. General principles B. Treatment of non-pregnant adults with mild or uncomplicated influenza C. Treatment of non-pregnant adults with moderate, progressive, severe or complicated illness with or without risk factors D. Treatment of infants, children and youth with mild or uncomplicated influenza illness E. Treatment of infants, children and youth with moderate, progressive, severe or complicated influenza illness with or without risk factors F. Treatment of immunocompromised patients G. Treatment of patients with renal impairment H. Treatment of pregnant women VII. RECOMMENDATIONS FOR CHEMOPROPHYLAXIS VERSUS EARLY THERAPY TABLES 1. Grading of recommendations 2. Clinical signs warranting urgent medical attention in infants, children and youth with suspected or proven influenza 3. At-risk groups and co-morbid medical conditions that predispose to severe influenza 4. Oseltamivir and zanamivir regimens 5. Recommended regimens for treatment of patients with renal impairment or failure 6. Selected surrogate indices of immunocompromised states REFERENCES APPENDICES A. Oseltamivir and zanamivir treatments for mild or uncomplicated influenza in non-pregnant adults B. Oseltamivir and zanamivir treatments for non-pregnant adults with moderate, progressive, severe or complicated illness C. Oseltamivir and zanamivir treatments for influenza in children (

H Grant Stiver - One of the best experts on this subject based on the ideXlab platform.

  • Guidance on The Use of Antiviral Drugs for Influenza in Acute Care Facilities in Canada, 2014-2015
    Canadian Journal of Infectious Diseases & Medical Microbiology, 2020
    Co-Authors: H Grant Stiver, Gerald A Evans, Fred Y. Aoki, Upton Allen, Michel Laverdière
    Abstract:

    A. Process Statement The development of this updated guidance arose in November 2014 from information provided by the Public Health Agency of Canada regarding early data indicating a mismatch of the influenza vaccine H3N2 component to an emerging H3N2 seasonal strain. This created a need to update recommendations for the use of antiviral drugs for this year’s seasonal influenza. The concept was then approved by Association of Medical Microbiology and Infectious Disease (AMMI) Canada. A first draft was cowritten by all the authors (HGS, FYA, UDA, GAE and ML). Subsequently, all the authors reviewed, revised and approved the document before a further review from the AMMI Canada Guidelines Committee and the Infectious Diseases and Immunization Committee of the Canadian Paediatric Society. AMMI Canada approved the final document before submission to the Journal for publication.

  • The Use of Antiviral Drugs for Influenza: A Foundation Document for Practitioners
    Canadian Journal of Infectious Diseases & Medical Microbiology, 2020
    Co-Authors: Upton D Allen Mbbs, H Grant Stiver, Gerald A Evans
    Abstract:

    1C INDEX I. PURPOSE II. Process Statement III. GRADING OF RECOMMENDATIONS IV. THE DISEASE A. Influenza viruses B. Clinical aspects C. Clinical diagnosis of influenza illness V. TREATMENT OF INFLUENZA ILLNESS A. Antiviral drugs including off-label use B. Benefits of antiviral treatment C. Considerations in selecting treatments 1. Severity of illness 2. Presence of risk factors or co-morbid medical conditions 3. Interval between onset of illness and initiation of antiviral therapy 4. Likely influenza type(s) causing infection D. Treatment of children E. Treatment of immunocompromised patients F. Treatment of patients with renal impairment G. Treatment of pregnant patients VI. RECOMMENDATIONS FOR TREATMENT A. General principles B. Treatment of non-pregnant adults with mild or uncomplicated influenza C. Treatment of non-pregnant adults with moderate, progressive, severe or complicated illness with or without risk factors D. Treatment of infants, children and youth with mild or uncomplicated influenza illness E. Treatment of infants, children and youth with moderate, progressive, severe or complicated influenza illness with or without risk factors F. Treatment of immunocompromised patients G. Treatment of patients with renal impairment H. Treatment of pregnant women VII. RECOMMENDATIONS FOR CHEMOPROPHYLAXIS VERSUS EARLY THERAPY TABLES 1. Grading of recommendations 2. Clinical signs warranting urgent medical attention in infants, children and youth with suspected or proven influenza 3. At-risk groups and co-morbid medical conditions that predispose to severe influenza 4. Oseltamivir and zanamivir regimens 5. Recommended regimens for treatment of patients with renal impairment or failure 6. Selected surrogate indices of immunocompromised states REFERENCES APPENDICES A. Oseltamivir and zanamivir treatments for mild or uncomplicated influenza in non-pregnant adults B. Oseltamivir and zanamivir treatments for non-pregnant adults with moderate, progressive, severe or complicated illness C. Oseltamivir and zanamivir treatments for influenza in children (

Michel Laverdière - One of the best experts on this subject based on the ideXlab platform.

  • Guidance on The Use of Antiviral Drugs for Influenza in Acute Care Facilities in Canada, 2014-2015
    Canadian Journal of Infectious Diseases & Medical Microbiology, 2020
    Co-Authors: H Grant Stiver, Gerald A Evans, Fred Y. Aoki, Upton Allen, Michel Laverdière
    Abstract:

    A. Process Statement The development of this updated guidance arose in November 2014 from information provided by the Public Health Agency of Canada regarding early data indicating a mismatch of the influenza vaccine H3N2 component to an emerging H3N2 seasonal strain. This created a need to update recommendations for the use of antiviral drugs for this year’s seasonal influenza. The concept was then approved by Association of Medical Microbiology and Infectious Disease (AMMI) Canada. A first draft was cowritten by all the authors (HGS, FYA, UDA, GAE and ML). Subsequently, all the authors reviewed, revised and approved the document before a further review from the AMMI Canada Guidelines Committee and the Infectious Diseases and Immunization Committee of the Canadian Paediatric Society. AMMI Canada approved the final document before submission to the Journal for publication.

Meenakshi Krishnan - One of the best experts on this subject based on the ideXlab platform.

  • ASSESSMENT OF THE EFFECTIVENESS OF INFORMATION BOOKLET ON KNOWLEDGE REGARDING MODIFIED LAMAZE METHOD AMONG MIDWIVES IN SELECTED HOSPITAL INDORE
    International Journal of Nursing, 2020
    Co-Authors: Priyanka Dutta, Anjali Masih, R. Thakur, Meenakshi Krishnan
    Abstract:

    The Lamaze method is employed during pregnancy and childbirth to teach women to respond positively to the pain of labor. Mothers and their partners are taught focused breathing techniques, movement and positioning, massage, and relaxation throughout labor. The Process is intended to contribute to the Process of labor without the use of drugs. While this method is widely practiced, this method is not necessarily the right one for everyone. Lamaze is important in making an educated and appropriate decision in the child bearing Process. Statement OF THE PROBLEM  “A study to assess the effectiveness of information booklet on knowledge regarding modified Lamaze method among midwives in selected hospital Indore.” OBJECTIVE To assess the pre-test knowledge regarding modified Lamaze method. To assess the post test knowledge regarding modified Lamaze method. To assess the effectiveness of information booklet on knowledge regarding modified Lamaze method. To find out the association between knowledge and selected demographic variable. Hypothesis RH1:- The mean post test knowledge scores of the midwives regarding modified Lamaze method significantly higher than mean per test knowledge. RH2:- There will be significant association between pre and post knowledge score with the selected demographic variable.