Discover and read the best of Twitter Threads about #fda

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Today #FDA announced a number of important new steps and actions to advance our consideration of a framework for the lawful marketing of appropriate cannabis and cannabis-derived products under our existing authorities: go.usa.gov/xm3d5
FDA’s steps include a public hearing on May 31 for stakeholders to share experiences/challenges w/ these products, formation of a high-level internal agency working group to explore potential product pathways, web QA updates & new warning letters for unfounded marketing claims.
We remain committed to exploring an appropriate, efficient and predictable regulatory framework to allow product developers that meet the requirements under our authorities to lawfully market these types of products.
Read 6 tweets
Today’s #FDA #SundayTweetorial is personal. I look back at what we've accomplished at FDA to advance innovations to benefit patients, promote policies to protect consumers, and address public health challenges during the two years I've shared these experiences with my colleagues.
I was truly fortunate to arrive at #FDA at an inflection point in medicine, health, and science – during a time when new discoveries, made right down to the molecular level, offer the potential to transform health, protect consumers, and cure disease in fundamentally novel ways.
Each novel medical technology challenged #FDA to be nimble and creative in its approach to product evaluation so that innovation would not only advance efficiently to benefit patients but do so while strengthening the agency’s gold standard for safety and effectiveness.
Read 46 tweets
The U.S. is facing a new epidemic sparked by the surging popularity of e-cig use by kids. Halting this public health crisis requires forceful steps from FDA. In today’s #FDA #SundayTweetorial I’ll detail what we advanced last week – and why. And what additional steps we may take.
To explain, let’s go back a bit in time to see how this issue has evolved. In 2017, early after I became commissioner, #FDA was poised to put us on a path to overcome one of the most pernicious public health challenges of our times – death and disease caused by cigarette smoking.
I saw the chance to advance new technologies like electronic cigarettes as part of that plan. We saw these products as potentially less harmful alternatives to cigarettes for some adult smokers seeking access to nicotine, without all the deadly effects of combustion.
Read 28 tweets
Re: #FDA Compliance Policy Mod for Certain #Tobacco products.

The real timeline here starts with 2010 when @FDATobacco was denied authority to regulate #vaping as a drug/device. That's we knew for certain that these products would be regulated. . .
. . . under the TCA. But now, after YEARS of failing to provide meaningful guidance to industry regarding PMTA and/or streamlining the process for low-risk tobacco and #nicotine products, @FDATobacco is claiming . . .
. . .that a sudden spike in youth trying #vaping in 2017-2018 is responsible for derailing their efforts to ensure access to safer tobacco/nicotine products.

Moreover. . .
Read 6 tweets
One of the most troubling public health issues today is the escalating popularity of e-cigarettes among our nation’s youth. In today’s #FDA #SundayTweetorial I’m laying out our case for why vaping endangers the health of youth.
Anecdotally, I’ve heard from parents of kids who are addicted – telling me how easy it is for teens to buy and use e-cigarettes, how e-cig images are all over social media, and how their kids tell them that so many of their friends in high school are using these products.
You’ve probably heard those reports, too. But my comments today aren’t based on anecdotes. They’re informed by a growing body of evidence showing e-cigarette use by youth is truly a health epidemic—and one with the potential for serious consequences.
Read 19 tweets
Our #FDA #SUNDAYTWEETORIAL is BACK! Are you throwing a party this #SuperBowl Sunday? Don’t forget to tackle food safety. In today’s Tweetorial, I’ll be serving up a defensive game plan for how you can best protect your family and friends from foodborne illness during the telecast
We know that three common foodborne bacteria like to crash parties. They are Staphylococcus aureus, Clostridium perfringens and Listeria monocytogenes. And unlike microbes that cause food to spoil, you can’t detect these bacteria by smelling or tasting them.
So, what to do? Consider following this four-step game plan. It involves Cleaning (hands, utensils surfaces); Separating (Don’t cross-contaminate); Cooking (use a food thermometer): and Chilling (food promptly), + a few added tips for entertaining go.usa.gov/xE9AJ.
Read 16 tweets
THREAD: We announced two more steps in efforts to modernize FDA’s 510(k) path for medical devices. go.usa.gov/xEZwe 510(k) devices coming to market should account for advances in technology that improve safety or performance or meet modern safety and performance criteria.
Our final guidance issued today establishes an approach whereby manufacturers of certain devices may be able to demonstrate that their products meet objective safety and performance criteria that are based on modern technological principles.
We’re also seeking comment on steps we could take to further encourage development of innovations that enhance the safety of 510(k) devices, including whether we should post a list of #FDA-cleared devices that demonstrated substantial equivalence to older predicate devices.
Read 4 tweets
SHUTDOWN UPDATE: We’ve been recalling inspectors to perform critical, high risk food safety inspections. We’ve been asked how many dedicated colleagues are currently working on these unpaid assignments. More people are on the way. Here’s a current snapshot of our field resources:
So far we’ve called back about 100 investigators and 35 supervisors to conduct and support domestic food surveillance inspections of high risk products. These professionals are in addition to FDA staff who were already working high-risk inspections, like foreign food assignments.
In addition, at #FDA’s Office of Import and Enforcement Operations, which cover International Mail Facilities and ports of entry, we have about 450 FDA staff in the field - including investigators, compliance experts and supervisors - supporting these critical safety operations
Read 4 tweets
THREAD: We appreciate US PIRG’s interest in the safety of the nation’s food system and we always welcome a larger conversation on the topic. Public health is our top priority and FDA is working hard to ensure the U.S. food supply remains among the safest in the world.
While we agree with the premise that prevention is always better than a corrective action, such as executing a recall, there should be caution in using recall numbers alone as the sole metric for gauging long-term performance trends in food safety.
Dramatic improvements in new tools to detect foodborne pathogens has likely resulted in an increased # of recalls. The complexity of supply chain for foods has also increased so one contaminated ingredient can trigger many recalls, which can affect the overall number of recalls.
Read 7 tweets
The anti-vax movement has been listed by WHO as one of its top 10 health threats for 2019
newsweek.com/world-health-o…

#WeThePeople WILL WIN!!!🙏🏻♥️
#QAnon #MAGA @WhiteHouseHstry
@realDonaldTrump ’s new @HHSGov department may BAN #MandatoryVaccinations nationwide and restore health and religious freedom explainlife.com/trumps-new-hhs…

#QAnon #MAGA #WeThePeople WILL WIN!!!🙏🏻♥️
@realDonaldTrump @WhiteHouseHstry #vaccines #antivax #AntiVaxxers
#BillGates' Former Doctor Says Billionaire ‘Refused To Vaccinate His Children’ explainlife.com/bill-gates-for…

#QAnon #MAGA #WeThePeople WILL WIN!!!🙏🏻♥️
@realDonaldTrump @WhiteHouseHstry #vaccines #antivax #AntiVaxxers
Read 21 tweets
THREAD: We’re getting many questions about when #FDA can continue to accept medical product applications during the lapse in funding. The questions tonight relate to one particular biotech firm. However, I'm addressing the issues generally, and not specific to one product.
For products covered by a user fee program, if the product sponsor submitted the application and paid any required fees before the lapse, FDA can use its limited carryover user fee funding to continue reviewing the application.
However, during the lapse, FDA cannot accept new medical product applications that require a fee payment. We are not allowed to accept new user fees. In these cases, sponsors will need to wait until the lapse is over to submit their applications to FDA for review.
Read 5 tweets
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.
We analyzed activities with close input from senior career leaders & public health experts. Our plans always included activities to address immediate threats to human life & safety. But as lapse continues we’re evaluating additional activities we need to except to prevent threats
FDA determined after careful analysis and in close consultation with senior career leaders and public health experts that the following activities should be considered excepted, unpaid work because they’re necessary to identify and respond to threats to safety of human life:
Read 12 tweets
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:
First, I want to reassure everyone that while it’s not business as usual at the agency, we are continuing to prioritize our device safety work both before AND after medical devices come to market.
With respect to post-market efforts, the agency is currently monitoring ALL medical device adverse events it receives, looking for concerns and signals that need to be addressed. If we find issues, we can and will act to protect Americans from imminent threats to health.
Read 6 tweets
THREAD: we’ve received questions from reporters and others related to the generic drug review program at #FDA; and what review activities will continue during the shutdown. I want to provide some information related to these inquiries:
During the lapse period, FDA will not accept generic drug submissions that require payment of a fee (e.g., Abbreviated New Drug Applications (ANDAs))
FDA will accept generic submissions for which no fee is required, if product is within the scope of the GDUFA program. These submissions include, for example: CBE supplements and prior approval supplements to approved ANDAs, Amendments, Annual reports, Applications for PET drugs
Read 8 tweets
THREAD: #FDA will continue to advance certain policy, consistent with what's permissible under law. Carryover user-fees support important actions, including developing guidance and advancing policies that further FDA’s regulatory oversight of medical products and animal drugs.
#FDA will also use carryover funding to support development of medical products. This includes participating in pre-approval discussions with sponsors seeking guidance on how to go forward with clinical research and other ongoing discussions to help advance development programs.
However, this doesn't mean it's business as usual at #FDA; the lapse in funding will limit many medical product related activities, including the development of certain guidances. We also cannot accept new applications for medical products that require the payment of a user fee.
Read 16 tweets
As a science-based agency we rely on evidence generated from data to inform regulatory decisions. #FDA's #SundayTweetorial discusses how we use data from real-world settings to enhance what we know about medical products. This week we'll announce policies to advance these efforts
What I’m talking about is the use of “real-world data” (RWD) to generate “real-world evidence” (RWE), concepts promoted by Congress in 21st Century Cures Act of 2016 and of great interest to #FDA bit.ly/2MUOEL0. To better understand our efforts, let’s define some terms.
RWD are data relating to patient health status and/or delivery of health care routinely collected from a variety of sources, including health insurance claims, electronic health records (EHRs), product and disease registries, lab results, patient-generated data and mobile devices
Read 23 tweets
Assuring the safety of medical products is central to FDA’s consumer protection mission. In today’s #FDA #SUNDAYTWEETORIAL I’m going to talk about FDA’s ambitious new safety goal for medical devices and our 510K reforms that, once implemented, will advance safety and innovation.
We've set a new goal that WE WILL achieve: Ensuring #FDA is consistently first among the world’s regulatory agencies to identify and act upon safety signals related to medical devices. This is a top priority. Many have asked me what does that mean? And how will #FDA do that?
First, a little background: #FDA regulates more than 190,000 different medical devices that are manufactured by more than 18,000 companies in more than 21,000 facilities worldwide. We approve, clear or grant marketing authorization to about 12 new or modified devices every day.
Read 26 tweets
THREAD: Thank you to the #ODAC for their robust discussion yesterday and engagement in the science that goes into developing and reviewing biosimilars. go.usa.gov/xP96X
#FDA is working to advance the science and policies to make the development of biosimilars more efficient, to increase the acceptance of biosimilars, and to avoid the regulatory gaming that can deter competition. go.usa.gov/xPcbB
Biologics have become a crucial tool in treating many serious and life-threatening diseases, including cancer. But their costs may be prohibitively high for some patients. #FDA is taking new steps to facilitate more competition from biosimilars to drive competition and access
Read 3 tweets
It’s the start of flu season – time to protect yourself and your family by getting vaccinated! In today’s #FDA #SUNDAYTWEETORIAL I’m going to talk about #FDA’s role in ensuring the safety, effectiveness, and availability of the 2019 influenza vaccines. #VaccinesWork #FightFlu
I know there are questions about the effectiveness and benefits of the flu vaccine given the severity of last year’s flu season, so I want to update you on what we’ve learned, the effectiveness of this year’s vaccine and why vaccination is important go.usa.gov/xPWhS.
We've made important modifications to this year's #Flu vaccine to improve its effectiveness; changing two of the strains (for the H3N2 and Influenza B components) to better reflect the influenza strains that we believe are most likely to circulate this winter. More on this later.
Read 22 tweets
Compounded drugs serve an important medical need for patients who can’t use an FDA-approved medication. In today’s #FDA #SUNDAYTWEETORIAL, I’m going to talk about what FDA is doing to preserve access to appropriately compounded drugs while protecting patients from serious risks.
In drug compounding, ingredients are combined, mixed or altered to create a sterile or non-sterile medication tailored to a patient - such as those with an allergy who need a drug without a certain dye or a child who can’t swallow a tablet and needs medicine in a liquid form.
But compounded drugs, which aren’t FDA-approved, may pose serious risks if not produced properly, potentially resulting in contamination or medications that do not possess the strength, quality or purity they are supposed to have bit.ly/2G7IpjB
Read 23 tweets
001/ [article content in this tweet series 001-180 reproduced with permission from Martin Howe QC of Lawyers for Britain @lawyers4britain]
#quote "Leaving the EU on WTO terms: pulling down the barriers to world trade
Introduction: why prices will FALL after Brexit, not rise" /002
002/ #quote "Over the past couple of weeks, the media have been full of lurid scare stories about what will happen if the UK leaves the EU on WTO terms, because negotiations with the EU do not result in a withdrawal agreement." /003
#tariffs #NoDeal #Brexit #WTO #ProjectFear #shortages #food #medicines
003/ #quote "One of the most ridiculous and UNJUSTIFIED of these absurd scare stories is that it will lead to higher prices, and even shortages, of foods and medicines." /004
Read 180 tweets
As kids are heading back to school, for this #FDA #SUNDAYTWEETORIAL I’m going to talk about MEASLES and the vital importance of vaccination. You may’ve seen recent news stories reporting cases of measles in parts of the US and EU. Most cases have occurred in unvaccinated people
In 2018 there have been 124 individual cases of measles in 22 states and D.C. Measles can spread when it reaches a community where there are groups of unvaccinated people. And travelers with measles continue to bring the disease into the United States go.usa.gov/xUzwa
Measles is caused by the rubeola virus and is highly contagious. It is normally passed through direct contact or through the air. The virus infects the respiratory tract, then spreads throughout the body, causing a skin rash, fever, cough and runny nose.
Read 19 tweets
Avevamo già accennato al fatto che la #GlaxoSmithKline fosse una tra le aziende farmaceutiche con più procedimenti penali.
Ecco un #tweetelling sul materiale che si riesce a scovare in rete che getta molte ombre sulla condotta commerciale del colosso.
Luglio 2012
La Glaxo viene condannata per il più grande caso di frode sanitaria negli #USA.
Un risarcimento di 3 miliardi di dollari per promozione illegale di farmaci e usi non autorizzati, corruzione di medici e scorretto utilizzo dei dati di sicurezza repubblica.it/salute/2012/07…
Giugno 2007
Caso #Avandia (Rosiglitazone)
Il @nytimesworld pubblica la trascrizione di una conversazione tra un medico e un dirigente della #Glaxo che nascondere i rischi legati al farmaco.
Nel novembre dello stesso anno è il Congresso degli #USA a denunciate la #GSK.
Read 26 tweets

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