Coronavirus torpedoes 50th L.A. Pride parade; online celebration planned
The L.A. Pride parade, which would have marked its 50th year, joins the list of events canceled or postponed because of the coronavirus outbreak.
The Check-In: Justin Turner unsettled at thought of not playing again for the Dodgers
The Dodgers' Justin Turner and his wife Kourtney have delivered more than 500,000 meals to the needy since March. He'll be a free agent this winter.
Andy Serkis (and maybe Gollum?) will read 'The Hobbit' for coronavirus charities
Andy Serkis, who plays Gollum in the "Lord of the Rings" films, announced that he will livestream a reading of J.R.R. Tolkien's "The Hobbit" on Friday.
California tops 2,500 coronavirus deaths as fears of second wave temper reopening efforts
Los Angeles County, which continues to be the hardest hit area in California, announced 51 additional deaths linked to COVID-19 on Thursday.
First coronavirus, now 'murder hornets'? 'The Simpsons' predicts the future again
Bill Oakley, a writer on "The Simpsons," admitted on Twitter that perhaps the animated TV show did forecast some of our troubling current events.
COVID-19 cases higher among San Diego's Latinos; advocates call for more testing
In several states and in parts of California, black and Latino people are dying of COVID-19 at higher rates than their white and Asian counterparts.
Face masks will be an even bigger part of L.A. life as reopening begins
Here is where masks are currently required, as well as proposals that would dramatically increase face-covering requirements.
I'm gaining weight in quarantine and I couldn't be more thrilled about it
If the worst thing that happens to me during this global pandemic is that I have to buy new pants, I will weep with gratitude.
MDR date of application move: politically a done deal now
With the overwhelming vote in the Parliament in favor of the Commission proposal to amend the MDR it is politically basically a done deal now that the MDR will be amended. After the vote there were people that immediately stated that the amendment was formally approved – not so. We are looking at law making […]
New MDCG guidance on temporary extraordinary measures related to medical device Notified Body audits during COVID-19 quarantine orders and travel restrictions
When it rains guidance, it pours. The MDCG just released Guidance on temporary extraordinary measures related to medical devices Notified Body audits during COVID-19 quarantine orders and travel restrictions. The guidance takes immediate effect and is valid for the whole period of duration of the pandemic COVID-19 as declared by the World Health Organisation. It […]
MDR amendment proposal article 120 (3) oversight set to be fixed by Council
It’s always a risk to put out a theory about legislative oversight after a Sherlock Homes investigation that eliminates all other options as I did in my last blog about the MDR amendment proposal. Recent development seem to confirm that I was right in assuming that not touching the two dates of application of 26 […]
The MDR amendment proposal: more than meets the eye
On Friday 3 April 2020 it finally happened: the Commission proposal for amendment of the MDR to defer the date of application with a year that everyone was waiting for and was in the works for some time was finally published. As I have heard from many directions immediately after the announcement of the proposal being […]
Commission working on proposal to postpone MDR date of application for one year
After a statement on a press conference today by Stefan De keersmaecker that had many people very excited quickly, the official announcement came later in the afternoon: Here is what I think about this development. Work on a proposal ongoing The Commission announced that ‘work on a proposal to postpone the date of application’. This tells […]
The MDR and the Covid-19 recommendation – a possible template for fixing the MDR and IVDR bottleneck
What is this recommendation about? Obviously this recommendation is an attempt of the Commission to manage administative barriers to placing PPE (personal protective equipment) and medical devices on the market that would be needed in the struggle to get the current Covid-19 pandemic under control. In my view you can also see this as a […]
New MDCG Class I Article 120 (3) and (4) MDR guidance – nothing new but nice summary of requirements
I have blogged before about the effects and possibilities of the Corrigendum of December 2019 for class I medical devices. I refer you to that blog for the background to this discussion, which covers the mechanics of timing. The draft corrigendum discussed in that blog was adopted as described. The new guidance The MDCG has […]
The MDCG cybersecurity guidance – a helpful rush job
It has been some time since the MDCG guidance on cybersecurity for medical devices was released (MDCG 2019-16 December 2019), so everybody has probably had the opportunity to get used to the document by now. While the document is by no means ideal or even flawless (congratulations MDCG on a glaring spelling mistake in the […]
The MDCG MDR joint implementation plan
The MDCG just published a joint implementation plan regarding the MDR. Here is my summary and analysis. It’s not a happy story. Not the IVDR This implementation plan is not about the IVDR, and the fact that it is not about the IVDR is information in itself. It means that the MDCG is not even […]
Brexit is a fact – now deal with it
Following the European Parliament’s vote, the Council has now also agreed to the Brexit with its decision on the conclusion of the withdrawal agreement on behalf of the EU. The EU Parliamentarians sang off the UK members and celebrated that they never have to speak to Nigel Farage again. UK EU civil servants are clearing […]
Coronavirus World Map: Tracking The Spread Of The Outbreak
A map of confirmed COVID-19 cases and deaths around the world. The respiratory disease has spread rapidly across six continents and has killed thousands of people.
Tracking The Pandemic: How Quickly Is The Coronavirus Spreading State By State?
View our map and graphics to see where COVID-19 is hitting hardest in the U.S., which state outbreaks are growing the fastest and which are leveling off.
So, You're Not Talking Much In Quarantine. Here's How To Keep Your Voice Healthy
With social distancing, many people are speaking less and their voices sound raggedy. NPR's Scott Simon talks with speech pathologist Sandy Hirsch, about keeping the voice sounding as it should.
Anti-Vaccination Activists Join Stay-At-Home Order Protesters
Among those rallying against state shutdown orders are anti-vaccination activists. They see these protests as a way to form political alliances that promote their movement.
Reopening After COVID: The 3 Phases Recommended By The White House
President Trump wants businesses to start reopening after the coronavirus forced shutdowns. Here's what the White House task force recommends for states.
COMIC: Hospitals Turn To Alicia Keys, U2 And The Beatles To Sing Patients Home
Call them victory anthems. Every time a patient with COVID-19 is well enough to be discharged, hospitals in New York and elsewhere play songs of celebration over the intercom. A doctor explains.
Public Health Experts Say Many States Are Opening Too Soon To Do So Safely
By Monday at least 31 states will be open or partially open. This as President Trump pushed for the country to get back to work despite public health experts warning that it's too soon.
What Happened Today: Health Care System Crumbles, Testing Questions
Marc Lipsitch, a professor of epidemiology at the Harvard School of Public Health, answers questions about access to testing for COVID-19, false-negative results and the challenges of mass testing.
Haitian Doctor Says This Is The Worst Epidemic He's Faced
A major health agency fears a humanitarian crisis. Migrant workers are returning home from the hard-hit Dominican Republic. Medical equipment is in short supply. And social distancing is improbable.
Coronavirus FAQs: Do Temperature Screenings Help? Can Mosquitoes Spread It?
And as summer nears, the question must be asked: Is it risky from a COVID-19 standpoint to go in a swimming pool?
More Census Workers To Return To Rural Areas In 9 States To Leave Forms
The Census Bureau says it plans to continue its relaunch of limited 2020 census operations on May 13, when the next round of workers is set to resume hand-delivering paper forms in rural communities.
Seen 'Plandemic'? We Take A Close Look At The Viral Conspiracy Video's Claims
The video has been viewed millions of times on YouTube via links that are replaced as quickly as the video-sharing service can remove them for violating its policy against "COVID-19 misinformation."
Google Says Most Of Its Employees Will Likely Work Remotely Through End of Year
The tech giant announces it is extending its previous work-from-home plans for most of its staff and will begin reopening offices this summer.
V-E Day: Europe Celebrates A Subdued 75th Anniversary During COVID-19 Pandemic
"Today, 75 years later, we are forced to commemorate alone, but we are not alone!" Germany's President Frank-Walter Steinmeier says, celebrating international unity in the post-war era.
Some Questions On The Future Of The Coronavirus Vaccine, Answered
Scientists work tirelessly to find a coronavirus vaccine. But there are some questions to answer: How soon a viable vaccine would be developed? Would billions of people worldwide be able to to get it?
As COVID-19 Pandemic Continues, Promotion of Unapproved “Cures” Abounds
May 4, 2020 – An important part of protecting the public health during the COVID-19 pandemic is making sure that the marketing of treatments or remedies that are not approved by the Food and Drug Administration (FDA) to treat the virus is stopped before consumers waste their money or potentially are harmed by these products. […]
COVID-19 Pandemic Likely to Affect FDA Product Approval Timelines
April 27, 2020 – As the COVID-19 pandemic continues, the Food and Drug Administration (FDA) must balance safeguarding public health with the desire for timely product reviews. Staff members at the Center for Drug Evaluation and Research and the Center for Biologics Evaluation and Research are working diligently to keep all of these balls in […]
Despite Late Changes and COVID-19, CCPA Enforcement Date Remains July 1
April 20, 2020 – With additional changes to the regulations still in administrative review and businesses grappling with pressing COVID-19 issues, a group of nearly 100 advertising trade associations, organizations and companies asked California Attorney General Xavier Becerra (D) to delay the July 1 enforcement date for the California Consumer Protection Act (CCPA). But it […]
FDA Streamlines COVID-19 Product Pathways, Continues to Crack Down on Misleading Claims
April 13, 2020 – The Food and Drug Administration (FDA) is responding to the challenges of COVID-19 in new ways that streamline product review and policy approaches, while also ensuring that entities promoting unapproved products that claim to be effective against the virus do not go unchecked. Last week, the FDA and the Federal Trade […]
CHC Endorses Request Calling for Veto of Maryland Tax on Digital Advertising
April 6, 2020 – The Coalition for Healthcare Communication last week endorsed an urgent request to Maryland Governor Larry Hogan (R) to veto HB 732, which would put in place the nation’s first tax on digital advertising. The request, sent March 31 by national media and advertising trade associations and members of The Advertising Coalition, […]
Emergency Relief Package Yields Increased FDA Funding, OTC Revisions
March 30, 2020 – In addition to providing millions of Americans and many industries with financial support during the coronavirus outbreak, the emergency relief bill passed by Congress and signed into law by President Donald Trump on Friday accrues additional funding for the Food and Drug Administration’s coronavirus efforts and makes important changes to how […]
Amid COVID-19 Outbreak, Protecting 2020 Election Should Start Now
March 23, 2020 – As the United States grapples with the COVID-19 outbreak and its ongoing fallout, there is another pressing issue that is crucial to the American public: ensuring safe and fair elections between now and Nov. 3. “The Coalition believes it is important for all Americans to be active in the political process […]
FDA and FTC: Coronavirus Products Are Fraudulent, Could Delay Treatment
March 16, 2020 – Amid rising concerns over “Novel Coronavirus Disease 2019” (COVID-19), the Food and Drug Administration and the Federal Trade Commission took action last week against seven companies for selling fraudulent COVID-19 products. The regulators sent Warning Letters to the companies because these products “are unapproved drugs that pose significant risks to patient […]
Rising Leaders Conference Set for Nov. 18-19: Reserve Your Place Today!
March 12, 2020 —[Note: Due to the coronavirus epidemic, the Conference has been rescheduled from May.] Healthcare was already the top issue for voters—and the coronavirus pandemic only intensifies the focus heading into a hotly-contested election. Both parties want to “do something” about the cost of healthcare and especially drug prices, and what happens when […]
In Surprise Move, SCOTUS to Rule on Constitutionality of ACA Next Term
March 4, 2020 — The U.S. Supreme Court delivered a surprise on March 2 when it announced it will hear a challenge to the constitutionality of the Affordable Care Act (ACA) next term, leap-frogging over the process that was playing out in lower courts. Oral arguments have not yet been scheduled, but are likely to […]
Just 550 pharmacy staff referred for COVID-19 testing in first ten days of national scheme
Just over 550 community pharmacy staff members were referred for COVID-19 tests through a national booking system run by the Care Quality Commission, over ten days in mid-April 2020, the NHS watchdog has told The Pharmaceutical Journal.
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COVID-19 LATEST: Valproate reviews must not be delayed, says medicines regulator
All the most important developments in the COVID-19 pandemic for pharmacists and their teams, as they happen.
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NHS England advises pharmacies to 'risk assess' BAME staff for susceptibility to COVID-19
NHS England has advised pharmacies to risk assess staff who may be particularly vulnerable to COVID-19, including those from a black, Asian or minority ethnic background.
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Everything you should know about the coronavirus outbreak
The latest information about the novel coronavirus identified in Wuhan, China, and advice on how pharmacists can help concerned patients and the public.
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Manufacturer to move hydroxychloroquine production to the UK to avoid shortages
A manufacturer has announced plans to move production of hydroxychloroquine — currently being trialled as a COVID-19 treatment — to the UK from abroad to combat potential shortages.
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Wholesalers 'almost completely out' of government-supplied PPE, trade body warns
Wholesalers have “almost completely run out” of the personal protective equipment supplied by Public Health England for distribution to community pharmacies during the COVID-19 pandemic, the wholesaler trade body has warned.
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Community pharmacists will now be included in COVID-19 death-in-service scheme
Community pharmacists are to be included in the government life assurance scheme for staff working on the frontline of the COVID-19 pandemic, the health secretary, Matt Hancock has announced.
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