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Standards of Care I

Standards of Care I

Federal statutes profoundly impact nursing practice, providing critical guidelines to ensure patient care is equitable, accessible, and of the highest quality. The following laws address distinct aspects of healthcare provision and patient rights:

FDA Approved Drugs: Changes to Approved Drugs

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Post-approval, manufacturers may modify an approved new or generic drug product. Such modifications can encompass alterations in the Active Pharmaceutical Ingredient (API), manufacturing process, formulation, batch size, manufacturing site, and container closure system (FDA Guidance for Industry, April 2004). Often, a drug product may undergo multiple changes.These modifications require careful evaluation to determine their potential impact on the drug product's identity, strength, quality,...

Drug Regulation

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Drug regulation encompasses the management of drug usage by evaluating its safety and efficacy through assessments conducted by regulatory authorities. Regrettably, the history of drug regulation is marred by several catastrophic events. One such incident is the Elixir Sulfanilamide tragedy, in which the toxic compound diethyl glycol was included in a sweet-tasting medication, leading to numerous fatalities. This event prompted the enactment of the Food, Drug, and Cosmetic Act in 1938. Under...

Standards of Care II

Standards of Care II

Nurses bear specific legal responsibilities under several federal statutes, including:

Issues And Trends In Healthcare Delivery System

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The issues and trends in healthcare delivery are constantly changing. The COVID-19 pandemic is one recent issue that wreaked havoc on healthcare systems, causing a shortage of healthcare workers, high demand for medicines and supplies, and increased medical expenditure due to a lack of insurance. Other issues include rising healthcare costs and care fragmentation.
Cost Containment
Payment for healthcare services has historically promoted adoption of costly and often unnecessary or inefficient...

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Drug control governance involves the oversight and regulation of pharmaceuticals to ensure their safety and efficacy while preventing illegal drug use and trafficking. Regulatory bodies, including the US Food and Drug Administration (FDA) and the European Union's European Medicines Agency (EMA), play a central role in this process. These agencies evaluate the safety and efficacy of drugs before they can be marketed. They fund clinical trials and assess the benefits and risks associated with...

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Related Experiment Video

Updated: Nov 19, 2025

Live Imaging and Quantification of Viral Infection in K18 hACE2 Transgenic Mice Using Reporter-Expressing Recombinant SARS-CoV-2

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Published on: November 5, 2021

COVID-19 Changes in Laws and Regulations

Lynn S Muller¹

¹Lynn S. Muller, JD, BA-HCM, RN, CCM , is a nurse attorney, independent professional case manager, and managing partner of Muller & Muller. She is an adjunct professor in the MSN and DNP programs at Saint Peter's University of New Jersey. Lynn is a registered nurse and a board-certified case manager with extensive nursing and case management experience. Her law practice includes defense of health care professionals before the state licensing boards, consultant on such issues as regulatory compliance and accreditation, civil litigation, Wills, Trusts and Estates, and Family law. Lynn is the author of numerous articles and the legal chapters of the fourth edition of Case Management: A Practical Guide for Education and Practice and the second and third editions of the CMSA Core Curriculum for Case Management. Lynn is a contributor to the CCM Body of Knowledge (CMBOK), CMSA Career & Knowledge Pathways Project, and CMSA Standards of Practice for Case Management and is the contributing editor of Professional Case Management . She is as a former commissioner for the Commission for Case Management Certification (CCMC) and serves on the Professional Development and Education Task Force and is a facilitator for CCMC's 360, the 2-day immersion course.

Professional Case Management

|January 28, 2021

Summary

No abstract available in PubMed .

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