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Category: Regulatory


Regulatory

More restrictions expected in Europe as coronavirus spreads rapidly and rattles markets

September 21, 2020

Via: CNBC

European countries are likely to impose more restrictions on public life in the coming days as the number of daily coronavirus infections rises rapidly, analysts said. France reported 10,569 new cases Sunday (down from more than 13,000 new cases reported […]


Regulatory

Trump’s coronavirus vaccine czar says U.S. could immunize ‘most susceptible’ Americans by December

September 21, 2020

Via: CNBC

The United States could immunize Americans “most susceptible” to Covid-19 by December if a vaccine is approved before then, President Donald Trump’s coronavirus vaccine czar told CNBC on Monday. The U.S. could also immunize “most of the elderly” and health-care […]


Regulatory

HHS Outlines COVID Vax Distribution Strategy

September 17, 2020

Via: MedPageToday

The Health and Human Services (HHS) department on Wednesday unveiled general outlines for how the first COVID-19 vaccine doses will be shipped and administered. Developed with the Department of Defense (DOD), the four-part strategy addresses engagement with state and local […]


Regulatory

U.S. outlines sweeping plan to provide free COVID-19 vaccines

September 16, 2020

Via: Modern Healthcare

The federal government outlined a sweeping plan Wednesday to make vaccines for COVID-19 available for free to all Americans, even as polls show a strong undercurrent of skepticism rippling across the land. In a report to Congress and an accompanying […]


Opinions, Regulatory

Hospital-Acquired COVID; New Antibody Data; In FDA We Trust?

September 16, 2020

Via: MedPageToday

An average of 120 patients a day contracted COVID-19 inside U.S. hospitals, according to about 9 weeks of previously unpublished federal data provided by the CDC to the Wall Street Journal. As of 8:00 a.m. ET Wednesday, the unofficial U.S. […]


Opinions, Regulatory

U.S., European drugmakers pledge to make safety the main focus in coronavirus vaccine development

September 8, 2020

Via: CNBC

Nine leading U.S. and European vaccine developers pledged on Tuesday to uphold the scientific standards that their experimental immunizations will be held against, amid a hurried global race to contain the pandemic. The companies, including Pfizer, GlaxoSmithKline and AstraZeneca, in […]


Regulatory

Vaccine Multilateralism Is The Alternative To Vaccine Nationalism

September 3, 2020

Via: Forbes

The globe’s best bet at managing Covid-19 demands a global effort. At the moment this looks like the Covid-19 Vaccines Global Access (COVAX) Facility, which pulls together the buying power of most of the world’s countries and aims at fair […]


Regulatory

FDA approves Roche’s HIV-1/HIV-2 test for use in cobas Systems

September 2, 2020

Via: medicaldevice-network.com

Roche has received US Food and Drug Administration (FDA) approval for its cobas HIV-1/HIV-2 Qualitative test for use on fully automated cobas 6800/8800 Systems in the US. The test is an in vitro nucleic acid amplification assay for the qualitative […]


Regulatory

FDA approves Medtronic’s insulin delivery and monitoring system

September 1, 2020

Via: medicaldevice-network.com

The US Food and Drug Administration (FDA) has approved Medtronic’s MiniMed 770G System for use by paediatric patients aged between two and six years with type 1 diabetes. The system is a hybrid closed-loop diabetes management device, which automatically monitors […]


Regulatory

WHO says children do play a role in coronavirus spread, but schools are not a ‘main contributor’

August 27, 2020

Via: CNBC

The World Health Organization warned on Thursday that an increasing body of evidence suggests children do play a role in the spread of Covid-19, but classrooms are not thought to be a “main contributor” to the pandemic. It comes as […]


Regulatory

CDC quietly revises coronavirus guidance to downplay importance of testing asymptomatic people

August 26, 2020

Via: CNBC

The Centers for Disease Control and Prevention is no longer recommending testing for everyone who’s been exposed to Covid-19, saying people who don’t have symptoms “do not necessarily need a test.” The agency quietly revised its testing guidance for asymptomatic […]


Regulatory

Trump is sending fast, cheap COVID tests to nursing homes — but there’s a hitch

August 24, 2020

Via: The Medical News

The Trump administration’s latest effort to use COVID-19 rapid tests — touted by one senior official as a “turning point” in arresting the coronavirus’s spread within nursing homes — is running into roadblocks likely to limit how widely they’ll be […]


Regulatory

FDA Convalescent Plasma Treatment Paves Way For Permanent Reopening

August 24, 2020

Via: Forbes

If you know someone who has recovered from coronavirus, they probably hold the at least one of the keys to a successful reopening of the economy and the risk of infection. Bridge Towards A Vaccine The Food and Drug Administration […]


Regulatory

Biden targets Trump ACA lawsuit, promises national COVID-19 plan

August 21, 2020

Via: Modern Healthcare

Democratic presidential nominee Joe Biden on Thursday warned that President Donald Trump could take down the Affordable Care Act and promised a more coordinated national response to COVID-19. Biden’s speech was the culmination of a convention focused more on his […]


Regulatory

Germany, Spain record highest daily coronavirus infection rate since April as cases surge across Europe

August 20, 2020

Via: CNBC

Germany and Spain have both recorded their highest respective daily coronavirus infection rate since April, with other countries in the region also reporting a sharp rise in new cases. Several European countries have imposed travel restrictions, social-distancing measures and mask-wearing […]