Ferdous Al-Faruque retweeted
Compared to the torrent of guidances issued over the past few weeks, the US Food and Drug Administration was relatively quiet this week.
But @MedTech_Danny still has reporting from from Advamed's annual MedTech conference and more 👉 bit.ly/3sHPkdi
Ferdous Al-Faruque retweeted
The BA.5 bivalent booster is rolling out just after Labor Day in the US, as we learned this evening nytimes.com/2022/08/23/us/po…
Here are some thoughts on the potential merits and disadvantages for this plan
Ferdous Al-Faruque retweeted
‼️Happening Friday: Reporters from Afghanistan and the US will discuss the current state of #pressfreedom in the war-torn country at a virtual event on Aug. 26 at 11 a.m. @ElizHagedorn @zahraJoya @KarimiNazira @CombatJourno @RBlumenstein press.org/events/one-year-fa… – at Washington, DC
Ferdous Al-Faruque retweeted
After HHS announced its proposal on Aug. 4, Paul Chaplin, chief executive of Bavarian Nordic, called a senior US health official and accused the Biden administration of breaching its contracts with his company by planning to use the monkeypox vaccine doses in an unapproved manner
The monkeypox vaccine maker's CEO threatened to cancel ALL future orders after the U.S. announced a plan to stretch supply.
It was the latest in a monkeypox response beset by turf wars, ongoing surprises and muddled messaging wapo.st/3bYp8Gq w/ @ddiamond @bylenasun
Ferdous Al-Faruque retweeted
Digital Health Roundup, March 2021: Record-Breaking Funding, Exec Chats With Medtronic, Edwards LifeSciences medtech.pharmaintelligence.i… @EvanKirstel @IrmaRaste @Pharma_Intell @MedtechReed @BarneyMedtech @MedTech_Danny #medtech #ArtificialIntelligence #digitalhealth #COVID19
Ferdous Al-Faruque retweeted
Pfizer is confirming that the company won't be participating in Tuesday's vaccine summit at the White House.
Ferdous Al-Faruque retweeted
Krebs unleashed. ⤵️ Chris Krebs scrupulously avoided such direct criticisms of the president's statements when leading the gov's election security operations. He was nevertheless fired for vouching for the election's integrity.
Ferdous Al-Faruque retweeted
We appreciate @CommerceGov & @TradeGov’s hard work with us to achieve a one-year delay of EU Medical Device Regulation implementation until 2021 as the #medtech industry focuses on the COVID-19 fight. We’re seeking a similar delay for in vitro diagnostic regs scheduled for 2022.
Ferdous Al-Faruque retweeted
Medtech Insight is tracking the IVD companies manufacturing tests to detect #COVID19 - for news and updates on the global pipeline of coronavirus tests check out our report @Medtech_Insight #Medtech #Coronavirus
COVID-19 Fact File: Global Diagnostic Test Pipeline
bit.ly/33sjS5j #Medtech
Ferdous Al-Faruque retweeted
Currently experts expect over 1 million deaths in the U.S. since the virus was not contained & we cannot even test for it.
This will be recorded as a major preventable public health disaster. I will try to relate what I learned from a long day of calls about what is happening.
Ferdous Al-Faruque retweeted
Academic and public health labs can also be empowered to advance laboratory developed tests under the existing EUA. The EUA process - as general matter - doesn’t envision lab tests but is, instead, geared to kits; but it can be used constructively to give labs guidance on LDTs.
$QGEN says it will apply for FDA emergency authorization for its respiratory panel test including for the novel coronavirus that can return results in ~1hr, and is seeking similar approvals in other markets: corporate.qiagen.com/newsroo… #COVID19
Ferdous Al-Faruque retweeted
This morning’s classified coronavirus briefing should have been made fully open to the American people—they would be as appalled & astonished as I am by the inadequacy of preparedness & prevention.
Ferdous Al-Faruque retweeted
"Earlier this year, I spent hours trying unsuccessfully to get access to my health records and, to this date, still haven’t had my call returned to help me get into them. And I’m the secretary of Health and Human Services." - @SecAzar
#hdpalooza #NHPC
news.bloomberglaw.com/health…
Ferdous Al-Faruque retweeted
2019 reorg in FDA's device center was disruptive: Officials previously said less warning letters went out last year due tof staff learning curves, and the today's budget request also blames it on missed internal goals for processing adverse events and recalls. FDA says a-OK now
Ferdous Al-Faruque retweeted
FDA is planning a meeting in April to discuss its process for public device safety communications. These types of alerts used to be much fewer and far between, but now the agency averages about 15-20 per year fda.gov/medical-devices/work… #medtech
Ferdous Al-Faruque retweeted
On my #JPM2020 panel with @AashimaTweets from Google, Ken Ehlert from UHG, @othman from Color, Salesforce's Jujhar Singh & Novartis' VP of BD, there was one thing everyone agreed on:
2020 is the year we will see some movement on health data interoperability.
Hope so!
Ferdous Al-Faruque retweeted
Includes 12 medical device applicants - though at least three of them have tried and failed for add-on payments in past years.
This year we have an all-time record of 44 technologies under consideration for NTAP, including 26 new applicants. 4 years ago we only had 10 new applications. #StrengtheningMedicare
Ferdous Al-Faruque retweeted
Senators have been given a flashcard with suggested phrases to use to avoid reporters, per @caitlinconant and @Grace_Segers
cbsnews.com/live-updates/tru…
