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U.S. FDA retweeted
Scott Gottlieb, M.D. 8h
PDUFA is our most vulnerable program and will run out of money first. We’ll get into February but how far into Feb is still very fluid. We’re trying to free resources to extend its runway. We said 4/5 weeks counting this week. That could change but is our rough estimate right now
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U.S. FDA retweeted
Scott Gottlieb, M.D. Jan 14
UPDATE ON FOOD INSPECTIONS AND OTHER INSPECTION ACTIVITY: The response from our outstanding field force and inspectorate has been overwhelming and outstanding. They're among the finest, most dedicated professionals in our federal workforce and we're grateful for their service ->
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U.S. FDA retweeted
Scott Gottlieb, M.D. Jan 13
THREAD - SHUTDOWN UPDATE: The lapse in funding represents one of the most significant operational challenges in FDA’s recent history. But as an agency, we’re committed to fulfilling our consumer protection mandate, to the best of our abilities, under our current configuration.
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U.S. FDA retweeted
Scott Gottlieb, M.D. Jan 11
Replying to @SGottliebFDA
will issue within a month the guidance implementing the policy steps we announced in November to limit youth access and appeal of these products. But if these trends don’t reverse sharply and rapidly, I fear the consensus supporting these products for adults will disappear.
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U.S. FDA retweeted
Scott Gottlieb, M.D. Jan 11
Today, my colleagues who are very important to our mission yet find themselves furloughed, and many who are excepted and continue to work, will not get their usual pay. I deeply regret these hardships. And I admire very much their continued dedication to our special mission.
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U.S. FDA retweeted
Scott Gottlieb, M.D. Jan 11
My note to colleagues today. For many who are furloughed, and can’t check email, I share it here and on our website. On this day when many will receive no paycheck, we’re reminded of the special mission that binds us together in challenging work and difficult circumstances.
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U.S. FDA retweeted
Scott Gottlieb, M.D. Jan 11
I'm proud of the work done by FDA’s Generic Drug Program in ensuring Americans have access to high quality, lower cost, safe and effective generics. I’m committed to continuing to advance policies aimed at making it more efficient to bring generic competition to the market.
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U.S. FDA retweeted
Scott Gottlieb, M.D. Jan 11
In calendar years 2017-2018, approved or tentatively approved a total of 2,048 generic drugs, with two months in Fall 2018 seeing record-breaking generic drug approval totals.
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U.S. FDA retweeted
Scott Gottlieb, M.D. Jan 11
THREAD: Update on Shutdown - Questions are being raised around FDA’s efforts to support device safety during the partial lapse in funding, especially with respect to post-market surveillance. I want to provide some background:
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U.S. FDA retweeted
Scott Gottlieb, M.D. Jan 9
THREAD: Food Safety During Shutdown: We’re taking steps to expand the scope of food safety surveillance inspections we’re doing during the shutdown to make sure we continue inspecting high risk food facilities. 31% of our inventory of domestic inspections are considered high risk
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U.S. FDA retweeted
Scott Gottlieb, M.D. Jan 9
THREAD: Today issued a five-year strategic plan for the Sentinel System, which lays out the major goals associated with the future of Sentinel and serves as a roadmap to guide the development of the system over the next five years.
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U.S. FDA retweeted
Scott Gottlieb, M.D. Jan 8
. please have your guest Sara Doerr contact me. Nobody should be unable to access a clinical trial or compassionate use drug owing to the funding lapse. We will help her. Our drug review staff remains at their posts across our centers. CNN never contacted us before airing.
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U.S. FDA retweeted
FDA/CDRH Industry Jan 7
sharing new information about the Software Precertification Pilot , including an updated working model and 2019 plan to test the model
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U.S. FDA retweeted
FDA Drug Information Jan 7
Read our “Advancing Health Through Innovation: 2018 New Drug Therapy Approvals” report to learn about important new drug approvals in 2018 & innovative regulatory tools used to enhance efficiency and expedite the review and approval of drugs: .
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U.S. FDA retweeted
Scott Gottlieb, M.D. Jan 7
Despite the , today I was pleased to welcome 32 new user-fee funded employees to FDA. We're delighted to have them, and thankful that carryover balances allow us to finalize their start. Important to note, it represents only 48% of new staff we planned to on-board today.
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U.S. FDA retweeted
Scott Gottlieb, M.D. Jan 7
THREAD: Today we’re announcing the next phase of our Pre-Cert Pilot Program to test new approaches for the review of digital health devices to help support the development of new technologies that meet our safety and effectiveness standard.
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U.S. FDA retweeted
Scott Gottlieb, M.D. Jan 8
is broadening the reach of its “The Real Cost” Smokeless Tobacco Prevention campaign - which originally aimed to educate nearly 600K male teens in 35 rural U.S. markets - to place new ads in 20 states to ultimately reach nearly 3 million more youth.
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U.S. FDA retweeted
Scott Gottlieb, M.D. Jan 8
The safety of drugs that Americans rely on is a top priority for . Our post today discusses the work FDA has done in 2018 to make sure drugs we approve are not only effective, but safe.
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U.S. FDA retweeted
Scott Gottlieb, M.D. Jan 8
THREAD - UPDATE ON SHUTDOWN: We’re making decisions across our portfolio to focus resources to key consumer protection functions. One action we’ll be taking is to re-allocate user fee money from certain pre-market drug review work to post market drug safety surveillance.
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U.S. FDA Jan 8
Replying to @US_FDA
The latest highlights the Drug Safety Priorities 2018 report and how we keep pace with evolving technology – such as machine learning methods, mobile apps, social media, and electronic prescribing data, while ensuring patient privacy.
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