Search results

In the past decades cultural heritage stored at museums and archives has been returned to source communities in various forms and under diverse circumstances. This contribution to the Elements series explores and discusses specifically the return of digital 'ethnographic' images to indigenous and non indigenous people that share a common recent history of coexistence and dispute over the same territory that is to be understood in the light of the consolidation of a Nation State with a settler colonial logic. The author argues that the affective reception of what a given archive labels as tangible and intangible heritage varies according to each audience´s particular memory practices, historical experience and way of relating to shared hegemonic notions of 'whiteness' and 'indigeneity'.

Intro -- Preface -- Chapter 1 -- Telehealth Services Proposed for Medicare Part B Reimbursements, 2018: Fact Sheet* -- Introduction -- Five Conditions for Telehealth Services -- Process of Adding Services -- Proposed CY2018 Telehealth Services -- Chapter 2 -- Biologics and Biosimilars: Background and Key Issues* -- Summary -- Introduction -- Events Leading Up to Biosimilars Legislation -- New Regulatory Pathway for Biosimilars -- FDA Approval of Biosimilars -- Zarxio -- Inflectra -- Erelzi -- Amjevita -- Renflexis -- Cyltezo -- Mvasi -- FDA Issues Related to Biosimilars -- Naming -- Labeling -- Transition -- Interchangeability and Substitution -- Reauthorization of the Biosimilar User Fee Act (BsUFA) -- Federal Research and New Drug Development -- Appendix A. Major Laws on Biologics Regulation -- Relevant Laws -- Biologics Control Act of 1902 -- Pure Food and Drugs Act and the Federal Food, Drug, and Cosmetic Act -- The Public Health Service Act -- Regulation of Biologics by Federal Agencies -- Appendix B. Comparison of Biologic Drug Prices -- Appendix C. Top-Selling Drugs -- Appendix D. The Purple Book -- Chapter 3 -- CRISPR Gene Editing Research in Embryos Generates Scientific and Ethics Debate* -- CRISPR Research in Human Embryos -- Ethical Context -- Chapter 4 -- FDA Risk Evaluation and Mitigation Strategies (REMS): Description and Effect on Generic Drug Development* -- Summary -- Introduction -- History of FDA Drug Regulation -- Early FDA Risk Management Programs -- Risk Evaluation and Mitigation Strategies (REMS) -- Elements of REMS -- Examples of Approved REMS -- Effects of Restricted Distribution Programs on Generic Drug Development -- REMS and Generic Drug Development -- Bioequivalence Testing -- Developing a Single, Shared System of ETASU -- Non-REMS Restricted Distribution Programs -- Issues for Congress -- Legislative Proposals.