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FDA Spokesperson
Assistant Commissioner for Media Affairs, U.S. Food and Drug Administration
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FDA Spokesperson May 15
Today I leave FDA with a full heart. It has been an honor to be a part of this agency and to work with such amazing, mission-driven and dedicated people. Team OMA, thanks for all you do! For those who followed me, follow FDA’s press office at for the latest from FDA
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FDA Spokesperson May 8
I’m joined by the entire FDA press office in mourning the loss of Robert Pear of . Robert’s contributions are countless and we will miss working with him. Our thoughts are with his family and his colleagues at NYT.
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FDA Spokesperson May 2
Replying to @ScottGottliebMD
Thank you , for your very kind words and all of your support. It has been an absolute honor to be a part of the FDA and to work with such amazing and dedicated people - especially the OMA press and social media team!
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FDA Spokesperson retweeted
Dr. Ned Sharpless Apr 29
I’m pleased to announce the new FDA website is LIVE! The site is the gateway to info the public needs to make informed decisions quickly, on topics ranging from recalls to important safety alerts. Check it out at .
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FDA Spokesperson retweeted
Dr. Ned Sharpless Apr 25
Today, I had the pleasure of meeting several of the FDA team’s children in the FDA Innovation Lab as part of . They’re learning about what FDA does to keep the public safe and having a LOT of fun in the process.
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FDA Spokesperson Apr 25
Flagging: New study data shows a higher incidence of stroke or death when the Wingspan Stent System is used outside of FDA-approved indications for use. FDA reminds health care professionals to consider patient selection carefully.
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FDA Spokesperson Apr 25
. has been advancing policies to promote development of gene therapy. To that end, we appreciate the chance to work with to ensure govt is taking steps to support safe innovation while reducing duplicative and burdensome oversight of products.
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FDA Spokesperson Apr 25
In our latest , read how FDA launched a network of state-based Rapid Response Teams that operate by the principles of the Incident Command System/National Incident Management System to respond to human and animal food emergencies.
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FDA Spokesperson retweeted
Dr. Ned Sharpless Apr 25
FDA remains committed to addressing the national opioid crisis on all fronts, and one of many efforts being made is our launch today of a new education campaign to help Americans understand important role they play in disposing of unused opioids.
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FDA Spokesperson Apr 25
Replying to @FDASpox
Check out the PSAs that will be airing across the country and use the embedded links for your coverage on this important topic:
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FDA Spokesperson Apr 25
Flagging for reporters: New FDA campaign, “Remove the Risk,” to help Americans understand the important role they play in removing & properly disposing of unused prescription opioids from their homes.
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FDA Spokesperson Apr 25
Replying to @FDASpox
The final guidance on non-clinical bench performance testing — done before a device is used in patients to identify mechanical/design flaws & test safety/endurance — describes the content/format of info to support a premarket submission.
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FDA Spokesperson Apr 25
Replying to @FDASpox
The guidance on ultrahigh molecular weight polyethylene (a plastic) discusses the types of information device manufacturers should include in premarket submissions to demonstrate the material is safe and appropriate for use in their device.
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FDA Spokesperson Apr 25
Devices Alert: Today, FDA published two final guidances to help manufacturers demonstrate a medical device’s safety and performance: 1) final guidance on non-clinical bench testing 2) final guidance on the use of a specific material commonly used in orthopedic devices.
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FDA Spokesperson Apr 25
Flagging for reporters: FDA issued final guidance today to clarify for device manufacturers how to mark convenience kits with a unique device identifier. These kits contain 2 or more devices packaged together.
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FDA Spokesperson Apr 24
Replying to @FDASpox
FDA is advising consumers to not eat the recalled product & to consult their healthcare provider if they suspect that they have developed symptoms that resemble a Salmonella infection. They should also report their illness to FDA. Learn about Salmonella:
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FDA Spokesperson Apr 24
Replying to @FDASpox
is continuing to inspect & investigate the Caito Foods processing facility and also continuing a traceback investigation to identify the specific source of these melons. Updates will continue to be provided.
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FDA Spokesperson Apr 24
UPDATE: Today, is reporting 117 people have become ill from a multi-state outbreak, previously announced by & CDC, of Salmonella Carrau infections likely linked to pre-cut melons distributed by Caito Foods. A recall was issued. Learn more:
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FDA Spokesperson Apr 24
FDA detected Listeria monocytogenes in 19 of the facilities; however, only 1 of them was found to have the pathogen on a food-contact surface. Salmonella was detected in 1 facility. discusses how FDA worked w/ facilities to improve safety:
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FDA Spokesperson Apr 24
NEW REPORT: Today, released a report on its findings from inspections & environmental sampling for Listeria monocytogenes & Salmonella at 89 ice cream production facilities in 32 states.
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