Remarks as prepared for delivery

Thank you, Professor [Jennifer] Arlen, for that kind introduction and for everything you and your colleagues have accomplished at NYU

Remarks as prepared for delivery

Thank you, Buddy [Wilmer Parker], for that kind introduction

By Alice Li, MD, MSc, RAC (CAN), Regulatory Scientist, Cato Research FDA issued “The Abbreviated 510(k) Program – Guidance for Industry and Food and Drug Administration Staff” on 13 September 2019. The content of this guidance supersedes the content from 1998 guidance “The New 510(k) Paradigm – Alternate Approaches to Demonstrating Substantial Equivalence in Premarket …

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The FDA has issued emergency use authorization for Gilead Science Inc's (GILD) antiviral drug Remdesivir for the treatment of COVID-19 in adults and children hospitalized with severe disease.

From : Communities>>Regulatory Open Forum
Hello Anon, In the version, I usually put the last year or the year generally recognised, e.g. ISO 14971 being 2007.  Then for the publication date, I do put the latest version when published so would be April 2010.  Because of the way standards are amended and revised, it can be quite difficult to determine what to put on the cover sheet.  I would also rely a bit on the Recognized Standards list the FDA publishes:  https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfStandards/search.cfm  to list [More]

From : Communities>>Regulatory Open Forum
I disagree with Richard. I just had a conversation with the COVID-19 hotline (11:45 am, May 7) and asked about this issue after having read an update from the FDA that said UDIs for EUA devices are waived and GMPs are under limited enforcement. The person I spoke with said the update is correct and that UDIs are waived for EUA devices.  Feel free to contact me if you have any questions.  Bob Bard ------------------------------ Robert Bard JD, RAC [Managing Director] South Lyon MI United States - [More]

From : Communities>>Regulatory Open Forum
Bob, I stand corrected; if you confirmed with FDA that is good.  From what I was reading and seeing (I must have missed that update) there was nothing addressing UDI or no UDI.for EUA products.  (Personally I am a bit surprised at this since the whole concept of UDI is traceability and they waive this for emergency use products - when there is an issue this is where UDI becomes so important.  Shrugs.) ------------------------------ Richard Vincins RAC Vice President Global Regulatory Affairs --- [More]

From : Communities>>Regulatory Open Forum
Hello Richard, Yesterday, I received a follow up from the Hotline (CDRH-EUA-Templates ) to my query. I was reminded that the waiver to good manufacturing practice and labeling requirements were included in the individual authorization letter. The person responding to my question concerning the UDI requirement provided the following: UDI is not specifically noted; however we are not enforcing UDI during the emergency. The specific authorization letter I was reviewing was for [More]

Pharmacy staff who are thought to have died as a result of the COVID-19 pandemic are to be among the healthcare workers remembered with a minute’s silence on 28 April 2020.

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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 […]

The European Medicines Agency has begun a rolling review of data on Gilead’s remdesivir, positioning it to cut the time it takes to decide whether to approve the drug in COVID-19 patients.

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.

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 […]

As nations across the globe try to fight a pandemic, many also stop to mark the close of another conflict: the end of World War II in Europe.

The drug helped some coronavirus patients recover faster. But it's hardly everything we'd wished for.

Adam Silver told NBA players that a return to the court is up in the air but that games could be held in Las Vegas or Orlando, likely without fans.

Since the drug was granted emergency use authorization, doctors have been left with no clear path to get it.

Khurshid talks about challenges of his job, and in light of controversy surrounding Law Ministry.

Nov 28, 2018

Russian President Vladimir Putin’s eschatological talk of nuclear Armageddon at this year’s Valdai forum has stirred up heated debates on how well his description of Russia’s potential use of nuclear weapons matches the country’s official military doctrine. However, a close look at Putin’s Oct. 18 remarks and Russia’s 2014 military doctrine reveals that, while Putin deviated from the language in the doctrine, he did not lie on the first use issue. Nor did he seem to be hinting at a shift in Russia’s nuclear posture. More likely, he was signaling to Washington that the existing nuclear arms control treaties need to remain in place for the sake of ensuring strategic stability in the U.S.-Russian nuclear dyad and avoiding an accidental war between the two countries.

Lewis Hamilton is focused on helping McLaren bounce back, after his retirement from the Hungarian Grand Prix knocked him off the top of the drivers' championship

The future of the Belgian Grand Prix at the famous Spa Francorchamps circuit remains uncertain after this year's race fell more than 10,000 tickets short of its spectator target

Mark Webber's title chances took a massive blow in the Korean Grand Prix as the Red Bull driver crashed into retirement on lap 19 of a wet Korean Grand Prix

Valtteri Bottas remains a doubt for Sunday's Australian Grand Prix after spending the night in hospital with soft tissue damage to his back

Vitaly Petrov says that he wants to remain at Renault and partner Kimi Raikkonen next season, despite doubts over his future

Major changes are taking place in urban transportation and service delivery. There are shifts in car ownership, the development of ride-sharing services, investments in autonomous vehicles, the use of remote sensors for mobile applications, and changes in package and service delivery. New tools are being deployed to transport people, deliver products, and respond to a…

There remains confusion over how many teams will be on the grid in the season-opener in Bahrain next wee

Lewis Hamilton stayed positive after a puncture cost him second place in the Spanish Grand Prix on the penultimate lap

Fernando Alonso was left with "mixed feelings" following the Malaysian Grand Prix after he retired from his McLaren-Honda debut on the 21st lap with an ERS cooling problem

The remaining cars from the failed HRT team have been sold, signalling an end for the Spanish outfit

Mark Webber was clearly still far from happy with his team at the end of a weekend which will end with major concerns over the relationship between him and Sebastian Vettel

The considerable gains made worldwide in poverty reduction over the last 10 years have been widely recognized. And indeed, in a year when China aspires to complete its 40-year project of lifting some 770 million people across the poverty line, it is clear that a greater proportion of the human population is wealthier today than…

Introduction A combination of escalating costs, an aging population, and rising chronic health-care conditions that account for 75% of the nation’s health-care costs paint a bleak picture of the current state of American health care.1 In 2018, national health expenditures grew to $3.6 trillion and accounted for 17.7% of GDP.2 Under current laws, national health…