About 3,698 results

COVID-19 Emergency Declaration Blanket Waivers for Health Care Providers

The Trump Administration is taking aggressive actions and exercising regulatory flexibilities to help healthcare providers contain the spread of 2019 Novel Coronavirus Disease (COVID-19). CMS is empowered to take proactive steps through 1135 waivers as well as, where applicable, authority granted under section 1812(f) of the Social Security Act (the Act) and rapidly expand the Administratio...

Development and Licensure of Vaccines to Prevent COVID-19: Guidance for Industry

This guidance is being issued to address the coronavirus disease 2019 (COVID-19) public health emergency. This guidance is being implemented without prior public comment because the Food and Drug Administration (FDA or Agency) has determined that prior public participation for this guidance is not feasible or appropriate (see section 701(h)(1)(C) of the Federal Food, Drug, and Cosmetic Act ...

Evaluating and Testing Persons for Coronavirus Disease 2019 (COVID-19)

Clinicians considering diagnostic testing of people with possible COVID-19 should continue to work with their local and state health departments to coordinate testing through public health laboratories, or work with commercial or clinical laboratories using diagnostic tests authorized for emergency use by the U.S. Food and Drug Administration.

Fact Sheet for Health Care Providers Emergency Use Authorization (EUA) of Remdesivir (GS-5734™)

The U.S. Food and Drug Administration (FDA) has issued an Emergency Use Authorization (EUA) to permit the emergency use of the unapproved product remdesivir for treatment of suspected or laboratory confirmed coronavirus disease 2019 (COVID-19) in adults and children hospitalized with severe disease. Severe disease is defined as patients with an oxygen saturation (SpO2) ≤ 94% on room air or...

HHS Expands Access to Treatment for Opioid Use Disorder
US Department of Health & Human Services

Jan 13th, 2021 - Today, the U.S. Department of Health and Human Services is announcing it will publish Practice Guidelines for the Administration of Buprenorphine for Treating Opioid Use Disorder*, to expand access to medication-assisted treatment (MAT) by exempting physicians from certain certification requirements needed to prescribe buprenorphine for opioid use disorder (OUD) treatment.

The COVID-19 Treatment Guidelines Panel’s Statement on the Use of Tocilizumab for the Treatment of COVID-19
National Institutes of Health (NIH)

Mar 3rd, 2021 - Tocilizumab is a recombinant humanized anti-interleukin (IL)-6 receptor monoclonal antibody approved by the Food and Drug Administration (FDA) for the treatment of certain rheumatologic disorders and cytokine release syndrome induced by chimeric antigen receptor T cell (CAR-T cell) therapy. It is hypothesized that modulating the levels of proinflammatory IL-6 or its effects may reduce the durat...

American Society of Hematology/American Society of Clinical Oncology clinical practice guide...
J. Douglas Rizzo

Nov 5th, 2010 - For patients undergoing myelosuppressive chemotherapy who have a hemoglobin (Hb) level less than 10 g/dL, the Update Committee recommends that clinicians discuss potential harms (eg, thromboembolism, shorter survival) and benefits (eg, decreased transfusions) of ESAs and compare these with potential harms (eg, serious infections, immune-mediated adverse reactions) and benefits (eg, rapid Hb imp.

Air Travel During Pregnancy
Committee on Obstetric Practice

Oct 29th, 2009 - In the absence of obstetric or medical complications, occasional air travel is safe for pregnant women. Pregnant women can fly safely, observing the same precautions for air travel as the general population.

An Update of Evaluation of Intravenous Sedation on Diagnostic Spinal Injection Procedures
Howard S. Smith

Feb 19th, 2013 - Based on a review of the available evidence, it appears that the administration of mild to moderate sedation does not confound the results or diagnostic validity of spinal injection procedures. Specifically, immediate pain relief after cervical and lumbar facet joint controlled nerve blocks is not enhanced by IV sedation with midazolam or fentanyl.

Administration of influenza vaccines to egg allergic recipients: A practice parameter update...
Matthew Greenhawt

Dec 31st, 2017 - Annual seasonal influenza vaccination remains the most effective means of protection against contracting influenza illness and preventing spread of the disease among the population. 1 Influenza infection is a significant source of morbidity and mortality in the United States.

American Society for Parenteral and Enteral Nutrition Guidelines for the Selection and Care ...
Kovacevich, D.

Oct 18th, 2018 - This document represents the American Society for Parenteral and Enteral Nutrition (ASPEN) clinical guidelines to describe best practices in the selection and care of central venous access devices (CVADs) for the infusion of home parenteral nutrition (HPN) admixtures in adult patients. The guidelines targeted adults >18 years of age in which the intervention or exposure had to include HPN that.

AOSW Oncology Social Work Standards of Practice
Association of Oncology Social Work (AOSW)

Dec 31st, 2011 - Oncology social work is the primary professional discipline that provides psychosocial services to patients, families and significant others facing the impact of a potential or actual diagnosis of cancer. The scope of oncology social work includes clinical practice, education, advocacy, administration, policy, and research.

Clinical Practice Guideline: Capnography
Lambert, C.

Mar 16th, 2018 - Radiology and Imaging Nurses provide procedural sedation to a variety of patients. The administration of procedural sedation in the interventional radiology and diagnostic imaging suites presents a unique set of circumstances that can be challenging for the procedural sedation nurse.

Food and Drug Administration

Dec 7th, 2017 - This position statement is intended to be used by the industry to assist in communicating its positions on labeling, wholesale distribution, and GMPs when federal and state inspectors apply regulations that are either unnecessary or unsafe for designated medical gases or combinations thereof during facility inspections. A copy of this position statement has been provided to FDA’s Center for Dru.

Clinical Practice Guideline: Maintenance Intravenous Fluids in Children
Feld, L.

Nov 25th, 2018 - Maintenance intravenous fluids (IVFs) are used to provide critical supportive care for children who are acutely ill. IVFs are required if sufficient fluids cannot be provided by using enteral administration for reasons such as gastrointestinal illness, respiratory compromise, neurologic impairment, a perioperative state, or being moribund from an acute or chronic illness.

Does Early Goal-Directed Therapy Decrease Mortality Compared with Standard Care in Patients ...
Robert Sherwin, Michael Winters

Feb 16th, 2016 - Improvements in usual care can largely be attributed to the emphasis that the EGDT study placed on caring for patients with sepsis. Patients in the usual care arms of the ProCESS, ARISE, and ProMISE trials received aggressive intravenous fluids and early antibiotic medications.

Drug Stability Guidelines
Food and Drug Administration

Dec 8th, 2008 - The guideline is to be used as an aid in designing and conducting studies to establish drug stability in support of original, abbreviated or supplements to new animal drug applications (NADAs/ANADAs). The guideline will provide a framework within which stability studies can be conducted to provide meaningful and sufficient data.

Elimination of Perinatal Hepatitis B: Providing the First Vaccine Dose Within 24 Hours of Birth
American Academy of Pediatrics

Sep 29th, 2017 - After the introduction of the hepatitis B vaccine in the United States in 1982, a greater than 90% reduction in new infections was achieved. However, approximately 1000 new cases of perinatal hepatitis B infection are still identified annually in the United States.

Infection Using ERCP Endoscopes
Bret T. Petersen, Johannes Koch et. al.

Jun 30th, 2016 - The issue of patient-to-patient transmission of infection during endoscopic retrograde cholangiopancreatography (ERCP) continues to evolve. The occurrence of carbapenem-resistant Enterobacteriaceae infections after ERCP reached the awareness of the medical community in 2014 when the Centers for Disease Control and Prevention (CDC) published the findings of their investigation of a suburban Chic.

Injections and Implanted Drug Products (Parenterals)—Product Quality Tests
United States Pharmacopeia (USP)

Apr 30th, 2016 - Parenteral drug products include both injections and implanted drug products that are injected through the skin or other external boudary tissue, or implanted within the body to allow the direct administration of the active drug substance(s) into blood vessels, organs, tissues, or lesions. Injections may exist as either imeediate- or extended-release dosage forms that provide continuous release.