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An Open Letter from Daniel O’Day, Chairman & CEO, Gilead Sciences

After receiving the green light from the FDA to move forward, Gilead is about to start trials of an inhaled version of remdesivir. We will screen healthy volunteers for Phase 1 trials this week and hope to begin studies in patients with COVID-19 in August. If the trials are successful, this could represent important progress. Remdesivir, our investigational antiviral medicine, is currently give...

Fraudulent Coronavirus Disease 2019 (COVID-19) Products

The U.S. Food and Drug Administration is issuing warning letters to firms for selling fraudulent products with claims to prevent, treat, mitigate, diagnose or cure coronavirus disease 2019 (COVID-19). We are actively monitoring for any firms marketing products with fraudulent COVID-19 prevention and treatment claims. The FDA is exercising its authority to protect consumers from firms selling un...

CURE Drug Repurposing Collaboratory

The CURE Drug Repurposing Collaboratory (CDRC) is a public-private partnership initiated in June 2020 by C-Path and the U.S. Food and Drug Administration (FDA) in partnership with the National Center for Advancing Translational Sciences (NCATS), part of the National Institutes of Health (NIH). CDRC, in partnership with the FDA-NCATS CURE ID* platform, is a dedicated initiative designed to ca...

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...

A Cheap, Simple Way to Control the Coronavirus

Simple at-home tests for the coronavirus, some that involve spitting into a small tube of solution, could be the key to expanding testing and impeding the spread of the pandemic. The Food and Drug Administration should encourage their development and then fast track approval.

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 ...

Is cannabidiol the ideal drug to treat non-motor Parkinson’s disease symptoms?
European Archives of Psychiatry and Clinical Neuroscience;

Parkinson’s disease (PD) is a chronic neurodegenerative disorder characterized by motor symptoms such as bradykinesia, rest tremor, postural disturbances, and rigidity. PD is also characterized by non-motor symptoms such as sleep disturbances, cognitive deficits, and psychiatric disorders such as psychosis, depression, and anxiety. The pharmacological treatment for these symptoms is limited in ...

Levodopa-induced abnormal involuntary movements correlate with altered permeability of the blood-brain-barrier in the basal ganglia
Scientific Reports;

Chronic levodopa treatment leads to the appearance of dyskinesia in the majority of Parkinson’s disease patients. Neurovascular dysregulation in putaminal and pallidal regions is thought to be an underlying feature of this complication of treatment. We used microPET to study unilaterally lesioned 6-hydroxydopamine rats that developed levodopa-induced abnormal involuntary movements (AIMs) after ...

Recommendations of the Advisory Committee on Immunization Practices (ACIP)

These recommendations represent the first statement by the Advisory Committee on Immunization Practices (ACIP) on the use of a live attenuated vaccine for the prevention of herpes zoster (zoster) (i.e., shingles) and its sequelae, which was licensed by the U.S. Food and Drug Administration (FDA) on May 25, 2006. This report summarizes the epidemiology of zoster and its sequelae, describes the z...

Enforcement Policy for Viral Transport Media During the Coronavirus Disease 2019 (COVID19) Public Health Emergency: Guidance for Commercial Manufacturers, Clinical Laboratories, and Food and Drug A...

electroCore, Inc., gammaCore Sapphire CV - Letter of Authorization

This letter is in response to your request on behalf of electroCore, Inc. that the U.S. Food and Drug Administration (FDA) issue an Emergency Use Authorization (EUA) for the emergency use of the gammaCore Sapphire CV, intended for acute use at home or in a healthcare setting to treat adult patients with known or suspected COVID-19 who are experiencing exacerbation of asthma-related dyspnea ...

Food bioactives, micronutrients, immune function and COVID-19

The development of targeted therapeutics against the novel coronavirus disease 2019 (COVID-19) is highly desirable butmay present a challengein the foreseeable future.Adequate nutrition is a prerequisite of an optimally functioning immune system.Nutritional approaches,including the administration of food bioactives and micronutrients, may therefore have the potential to augmentimmune function a...

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.

Study Finds Patients With Lung Cancer Infected With COVID-19 Are at High Risk for Hospitalization

May 28th, 2020 - Data from the global TERAVOLT Consortium, which is investigating the impact of COVID-19 infection on patients with thoracic cancers, have found that these patients are at high risk for hospitalization and death. Prior use of chemotherapy was associated with an increased risk of mortality, as was the use of steroids or anticoagulants. Prior administration of immunotherapy and chemoimmunotherapy ...

COVID-19-Related Mortality Risk Increases With Recent Chemotherapy in Thoracic Cancer

May 27th, 2020 - The risk of death in patients with thoracic cancer was inflated with the administration of chemotherapy within 3 months of a coronavirus disease 2019 (COVID-19) diagnosis, findings from the global TERAVOLT Consortium registry show.

Evening versus morning dosing regimen drug therapy for hypertension

Variation in blood pressure levels display circadian rhythms. The morning surge in blood pressure is known to increase the risk of myocardial events in the first several hours post awakening. A systematic review of the administration‐time‐related‐effects of evening versus morning dosing regimen of antihypertensive drugs in the management of patients with primary hypertension has not been conduc...

Serious Adverse Health Events Associated with Methanol-based Hand Sanitizers

Most commercially available alcohol-based hand sanitizers or rubs (ABHSR) contain either ethanol or isopropanol as active ingredients. On June 19, 2020, the U.S. Food and Drug Administration (FDA) advised consumers not to use any hand sanitizer manufactured by “Eskbiochem SA de CV” in Mexico, due to the potential presence of methanol, a “toxic alcohol”, as an active ingredient, which can cause ...

We’re excited to invite you to Preventive Medicine 2020 Online!

While we moved our conference online to be socially distant, the future of preventive medicine has never been closer. Preventive Medicine 2020 Online will focus on big, bold, upstream ideas and the people, places, and programs that are making them a reality today. Transformation is only possible with a clear vision, audacious goals, an innovative mindset, and the will to implement new policy...


Amlodipine is an oral dihydropyridine calcium channel blocker. Compared to nifedipine and other medications in the dihydropyridine class, amlodipine has the longest half-life at 30 to 50 hours. The benefit of such a long half-life is the ability to have once-daily dosing. Amlodipine is available as amlodipine besylate, which was initially approved in 1987 by the Food and Drug Administration (FDA).

The COVID-19 Treatment Guidelines Panel’s Statement on the Emergency Use Authorization of Convalescent Plasma for the Treatment of COVID-19

On August 23, 2020, the Food and Drug Administration (FDA) issued an Emergency Use Authorization (EUA)* for COVID-19 convalescent plasma for the treatment of hospitalized patients with COVID-19.1,2 The COVID-19 Treatment Guidelines Panel (the Panel) reviewed the available evidence from published and unpublished data on convalescent plasma for the treatment for COVID-19, including the FDA analys...