men Sacramento-based Zennify buys Virginia tech firm specialized in AI development By www.bizjournals.com Published On :: Tue, 12 Nov 2024 22:39:07 +0000 Sacramento-based Zennify, a tech consulting firm for financial service companies, has acquired Terazo, a digital engineering firm based in Richmond, Virginia. Full Article
men Webinar to focus on IT workforce development By www.bizjournals.com Published On :: Tue, 12 Nov 2024 23:34:54 +0000 The free virtual event is hosted by SolluCIO Partners, a Seattle-based company with a presence in Hawaii. Full Article
men House, Senate strike a deal on economic development bill By www.bizjournals.com Published On :: Wed, 13 Nov 2024 01:21:02 +0000 Top Democrats on Tuesday evening filed a compromise economic development bill containing state support for the life sciences and climate technology industries, ticket sales regulations, a new live theater tax credit, educator diversity reforms and more. Full Article
men Yellowstone star’s comments on last episode will worry long-time fans By www.independent.co.uk Published On :: 2024-11-12T11:42:22+00:00 Viewers were left stunned by ‘savage’ exit of character in first episode of new season Full Article News TV & Radio Culture
men Strictly pro isn’t happy with BBC show’s treatment of Shayne Ward By www.independent.co.uk Published On :: 2024-11-12T11:57:59+00:00 ‘You deserve something better!’ Ward’s partner Nancy Xu said of result Full Article News TV & Radio Culture
men A Frank Assessment of Israel's Goals in Gaza From the Former Defense Minister By www.npr.org Published On :: Tue, 12 Nov 2024 15:46:52 -0500 Israel's Defense Minister was fired last week by Prime Minster Benjamin Netanyahu who said that trust had "eroded" between them. The now former defense minister met with families of Israeli hostages held in Gaza and gave his thoughts on what Israel can still achieve in Gaza. We hear what was said. Full Article
men Prostate Cancer is different for gay and bisexual men By www.starobserver.com.au Published On :: Mon, 18 Jan 2016 01:10:30 +0000 20,000 Australian men are diagnosed with prostate cancer every year. Research conducted by Prostate Cancer Foundation of Australia (PCFA), the Australian Research Centre in Sex, Health and Society, at La ... The post Prostate Cancer is different for gay and bisexual men appeared first on Star Observer. Full Article Healthy Living Sponsored Content
men Donald Trump Doesn’t Need Recess Appointments By www.nationalreview.com Published On :: Tue, 12 Nov 2024 11:30:20 +0000 And the Senate shouldn’t abandon its ‘advice and consent’ role. Full Article
men Apple now has replacement parts for the iPhone 16 series By www.engadget.com Published On :: Mon, 11 Nov 2024 14:30:00 +0000 It's no secret that most technology nowadays isn't exactly built to last forever, with new product models regularly on sale on replace malfunctioning items. However, Apple, which famously announces new products each September, is taking new steps to let people repair their own devices. Apple has launched parts and tools for the iPhone 16, including the Plus, Pro and Pro Max. Now, if you have an iPhone 16 model that's acting up, you can go to Apple's self service repair store and — possibly — get what you need to fix it. Choose the product type and model then pick from the iPhone 16's choices of back glass, battery, camera, top speaker, TrueDepth camera, SIM tray and more. Apple's iPhone 16 should be easier to fix than its predecessor, receiving a 7/10 on the iFixit repairability scale, compared to a 4/10 for the iPhone 15. You can either get kits or just the necessary part with prices varying based on your phone model. For example, a battery and screw kit for the iPhone 16 Pro Max is $119, but its $99 for the regular iPhone 16. You can get quite a lot of money back on the kit prices if you return the replaced piece afterward. The iPhone 16 Pro Max, for instance, goes down to $61.88 after you send back the old battery. Apple created its self-service program in 2022, giving its customers access to actual Apple parts when something in their device failed. However, Apple states that the service "is intended for individuals with the knowledge and experience to repair electronic devices. If you are experienced with the complexities of repairing electronic devices." So, repairs might not be as accessible if you or someone you know isn't savvy in making the swaps. This article originally appeared on Engadget at https://www.engadget.com/big-tech/apple-now-has-replacement-parts-for-the-iphone-16-series-143100070.html?src=rss Full Article Smart Phones Technology & Electronics Handheld & Connected Devices site|engadget provider_name|Engadget region|US language|en-US author_name|Sarah Fielding
men Discord leaker Jack Teixeira gets 15-year sentence for sharing classified documents By www.engadget.com Published On :: Tue, 12 Nov 2024 23:13:20 +0000 Massachusetts Air National Guard member Jack Teixeira received a 15-year sentence in federal prison for leaking classified military documents on Discord in a Boston federal court, according to The Washington Post. Teixeira appeared before the court earlier today and asked the judge for leniency. He also issued a statement apologizing for “all of the harm that I’ve caused, to my friends, family and those overseas.” Defense attorney Michael Bachrach also claimed that Teixeira was subjected to bullying in high school and his military unit as an adjudicating factor for his actions. Judge Indira Talwani didn’t buy the defense’s bullying claims stating that the Air Force has already disciplined 15 other members connected to Teixeira for not taking more actions “that might have stopped him from doing this.” Teixeira shared classified military documents as far back as late 2022 on a Discord server dedicated to the pixelated sandbox game Minecraft. The leak included information about the Ukrainian and Russian troop movements and military equipment used in the war in Ukraine and Russia's attempts to obtain more weapons from Egypt and Turkey. The documents eventually found their way to other Discord servers as well as 4chan and Telegram. FBI officials arrested Teixeira at his home in April of last year. Teixeira originally agreed to a plea deal with federal prosecutors in March that included a 16-year prison sentence for pleading guilty to six counts of willful retention and transmission of national defense information and violating the Espionage Act. If he stuck with his not guilty plea and received a guilty verdict, Teixeira faced a much steeper maximum prison term of 60 years.This article originally appeared on Engadget at https://www.engadget.com/cybersecurity/discord-leaker-jack-teixeira-gets-15-year-sentence-for-sharing-classified-documents-231319586.html?src=rss Full Article Politics & Government Military & Defense Society & Culture Crime & Justice Company Legal & Law Matters site|engadget provider_name|Engadget region|US language|en-US author_name|Danny Gallagher
men Elon Musk will lead a new ‘Department of Government Efficiency,’ Donald Trump says By www.engadget.com Published On :: Wed, 13 Nov 2024 01:55:21 +0000 President-elect Donald Trump has named Elon Musk as the leader of a new “Department of Government Efficiency," that will “dismantle Government Bureaucracy, slash excess regulations, cut wasteful expenditures, and restructure Federal Agencies.” The Tesla CEO and owner of X will spearhead the effort along with former presidential candidate Vivek Ramaswamy, Trump announced in a statement on Truth Social. The scope of the role isn’t exactly clear. Trump’s press release said that “the Department of Government Efficiency will provide advice and guidance from outside of Government, and will partner with the White House and Office of Management & Budget to drive large scale structural reform, and create an entrepreneurial approach to Government never seen before.” It also stated that “their work will conclude no later than July 4, 2026.” pic.twitter.com/Vnk4MCAofY— Elon Musk (@elonmusk) November 13, 2024 Musk shared the news on X, but didn’t indicate how the role might impact his obligations at his various other companies. Musk, who poured millions of dollars into Super Pac boosting Trump’s campaign, has previously talked about his desire to work with Trump to cut government spending. He did, however, joke about potential "merch" for the operation. "Republican politicians have dreamed about the objectives of 'DOGE' for a very long time," Trump's statement said. This article originally appeared on Engadget at https://www.engadget.com/big-tech/elon-musk-will-lead-a-new-department-of-government-efficiency-donald-trump-says-015521217.html?src=rss Full Article Politics & Government site|engadget provider_name|Engadget region|US language|en-US author_name|Karissa Bell
men Des chercheurs ont découvert comment diminuer les chances d'être attaqué par un requin en surf By www.journaldemontreal.com Published On :: Tue, 12 Nov 2024 09:06:36 EST Le grand requin blanc attaque souvent ses proies par en dessous, confondant parfois la silhouette d’un surfeur avec celle d’un phoque. Full Article
men Temple de la renommée: Jeremy Roenick raconte comment Doug Wilson lui a sauvé la vie By www.journaldemontreal.com Published On :: Mon, 11 Nov 2024 22:53:09 EST Jeremy Roenick nous a offert le moment le plus touchant de l’intronisation des membres de la cuvée 2024 du Temple de la renommée du hockey. Full Article
men NISAR satellite to offer precise monitoring of Earth's surface movements By www.terradaily.com Published On :: Wed, 13 Nov 2024 05:57:03 GMT Los Angeles CA (SPX) Nov 09, 2024 Data from NISAR will improve our understanding of such phenomena as earthquakes, volcanoes, and landslides, as well as damage to infrastructure. Earth's surface is in a state of continuous motion, although often unnoticed. Scientists have utilized satellite and ground-based technology to observe movements linked to geological events such as earthquakes, landslides, and volcanic activity. A Full Article
men From Beyoncé to brat summer, celeb endorsements and viral moments didn't matter much in this U.S. election By www.cbc.ca Published On :: Thu, 07 Nov 2024 04:00:00 EST While buzzy social media moments, massive celebrity endorsements and viral memes were everywhere during the U.S. election campaign, those who study social media and pop culture say it's likely that smaller social media interactions had a larger impact on the outcome. Full Article News/Entertainment
men Qu'est-ce que «4B», le mouvement radical féministe sud-coréen devenu viral aux États-Unis depuis la victoire de Donald Trump? By www.journaldemontreal.com Published On :: Tue, 12 Nov 2024 19:49:48 EST Non aux rencontres amoureuses, au sexe, au mariage ou à élever des enfants avec un homme. Full Article
men «C’était absolument nécessaire»: Laurence Jalbert a tout arrêté pendant deux mois pour guérir de la COVID By www.journaldemontreal.com Published On :: Tue, 12 Nov 2024 15:30:00 EST Laurence Jalbert a dû tout arrêter pendant deux mois Full Article
men Trump va nommer Elon Musk à la tête d’un ministère de l’«efficacité gouvernementale» By www.journaldemontreal.com Published On :: Tue, 12 Nov 2024 19:55:28 EST Donald Trump a indiqué mardi qu’il comptait nommer Elon Musk à la tête d’un ministère nouvellement créé de l’«efficacité gouvernementale» Full Article
men Trudeau government bans TikTok from operating in Canada — but Canadians can still use it By www.cbc.ca Published On :: Wed, 06 Nov 2024 17:30:48 EST Citing national security concerns, the federal government has ordered TikTok to shutter its Canadian operations — but users will still be able to access the popular video app. Full Article News/Politics
men Alberta government fires AIMCo board, four top executives, in 'reset' for pension fund manager By www.cbc.ca Published On :: Thu, 07 Nov 2024 16:13:46 EST The province says the move comes "after years of AIMCo consistently failing to meet its mandated benchmark returns." For now, Finance Minister Nate Horner has been appointed the AIMCo board's sole director and chair. Senior public servant Ray Gilmour has been appointed interim CEO. Full Article News/Canada/Edmonton
men Unemployment rate unchanged at 6.5% By www.cbc.ca Published On :: Fri, 08 Nov 2024 08:40:32 EST Canada's unemployment rate was unchanged in October at 6.5 per cent, while job growth was little changed from the previous month, Statistics Canada said Friday. Full Article News/Business
men Top Trump White House pick has strong view on Canada's government. It's not flattering By www.cbc.ca Published On :: Mon, 11 Nov 2024 22:55:49 EST Mike Waltz, the man reportedly tapped for the top international role inside the Trump White House isn’t just predicting the impending defeat of Canada’s Trudeau government: He’s celebrating it. Full Article News/World
men Kangaroos’ extraordinary punishment By www.news.com.au Published On :: Mon, 20 Jun 2016 22:59:00 GMT NORTH Melbourne coach Brad Scott’s embarrassing umpire’s scandal just got a whole lot worse for his football club and his own wallet. Full Article
men Can AI make life easier for people with dementia? By www.bbc.com Published On :: Tue, 29 Oct 2024 00:08:16 GMT AI projects are underway to help ease the challenges of dementia. Full Article
men Unemployment rises as pay growth slows again By www.bbc.com Published On :: Tue, 12 Nov 2024 10:29:28 GMT The rate of unemployment stood at 4.3% in the three months to September, up from 4% the previous quarter. Full Article
men Government to order review of rail fare prosecutions By www.bbc.com Published On :: Wed, 13 Nov 2024 06:09:01 GMT The way firms deal with fare evasion will be examined amid concern about how passengers are treated. Full Article
men DFAT makes room for women By www.theaustralian.com.au Published On :: Wed, 11 Jan 2017 13:00:00 GMT The Department of Foreign Affairs and Trade has renamed its meeting rooms in honour of pioneering female diplomats. Full Article
men Ralentir le vieillissement du cerveau By www.journaldemontreal.com Published On :: Thu, 26 Sep 2024 18:00:00 EDT Dans une étude, on rapporte qu’un médicament antidiabétique très utilisé retarde les effets négatifs du vieillissement sur les fonctions cognitives. Full Article
men SEC recommends marketing approval for Dr Reddy's SPMS drug Siponimod tablets By www.pharmabiz.com Published On :: Friday, November 8, 2024 08:00 IST The Subject Expert Committee (SEC), which advises the national drug regulator on approval of new drugs and clinical trials, has recommended grant of market authorisation for Dr Reddy's Laboratories' Siponimod Full Article
men SEC recommends approval for MSN Laboratories' sleep disorder drug By www.pharmabiz.com Published On :: Saturday, November 9, 2024 08:00 IST The Subject Expert Committee (SEC), which advises the national drug regulator on matters related to approval of new drugs and medical devices and clinical trials, has recommended grant of market authorisation for Full Article
men Centre notifies rules for recruitment of medical device officers in CDSCO By www.pharmabiz.com Published On :: Monday, November 11, 2024 08:00 IST In an effort to strengthen the regulatory activities for medical devices in the country, the Union health ministry has framed and finalised rules regulating the method of recruitment to various posts under the Central Full Article
men MSMEs in confusion as govt is keeping mum on demand for extending implementation of revised Schedule M By www.pharmabiz.com Published On :: Monday, November 11, 2024 08:00 IST Whilst the timeline set for adhering to the revised Schedule M of the Drugs and Cosmetics Act ends on December 31 for pharmaceutical companies with a turnover of less than Rs. 250 crore, the union ministry's Full Article
men Karnataka Ayush sector upbeat on recent amendment to renew manufacturing & loan licenses to perpetuity By www.pharmabiz.com Published On :: Monday, November 11, 2024 08:00 IST The recent amendments brought by the Union Ministry of Ayush to the Drugs and Cosmetics Rules, 1945 are significant, as they introduce new regulatory requirements for the manufacturing and sale of traditional Full Article
men Oversimplification about integration of traditional & modern treatment systems creates confusion: Dr Kotecha By www.pharmabiz.com Published On :: Tuesday, November 12, 2024 08:00 IST Oversimplification about integration of traditional and modern treatment systems often creates confusion among the stakeholders, and nobody understands the reality of the integration and what it is meant for, said Dr. Full Article
men Inter─ministerial committee calls for amendment in FSSAI Act on nutraceuticals By www.pharmabiz.com Published On :: Wednesday, November 13, 2024 08:00 IST An inter─ministerial committee formed by the Union health ministry has recommended amendments to the Food Safety and Standards Act, 2006 and regulations on nutraceuticals and health supplements, to shift regulation of Full Article
men Five steps to successful medical device development By www.medicalplasticsnews.com Published On :: Fri, 08 Nov 2024 16:30:00 -0000 Dr Euan McBrearty, head of commerical & innovation, Wideblue shares five steps to successful medical device development. Full Article
men Phone Attachment for Pupil Measurements with Any Skin Tone By www.medgadget.com Published On :: Mon, 20 Nov 2023 22:43:00 +0000 A research team at the University of California San Diego have developed a smartphone attachment that can provide information on changes in pupil size, which can be used to assess neurological phenomena, such as traumatic brain injury and Alzheimer’s disease. Such changes in pupil size have been difficult to characterize in the past in those […] Full Article Ophthalmology UCSD
men Informa Connect's Copay, Reimbursement and Access Congress By feeds.feedblitz.com Published On :: Mon, 30 Sep 2024 04:30:00 +0000 Informa Connect's Copay, Reimbursement and Access Congress November 18-20, 2024 | Hilton Penn’s Landing in Philadelphia, PA Drug Channels readers save 10% with code USAVE24* The access and affordability landscape is undergoing a seismic shift. Evolving legislation, disruptive market forces and the ever-growing complexities of cost sharing programs threaten patient adherence and commercialization strategies. Are you ready? A program driven by marketplace insights and led by industry trailblazers, Copay, Reimbursement and Access Congress is back November 18-20 and will deliver up-to-date insights necessary to enhance patient affordability, ensure program sustainability and navigate the regulatory landscape. In a time where remaining compliant has never been more complex and program innovation has never been more important, be sure to join your industry counterparts to drive adherence, access and commercialization forward. Why attend the Copay, Reimbursement and Access Congress? Keeping up with shifting market dynamics in the midst of maximizing access, while also meeting business objectives is a challenging task and brings about many questions for access professionals. Is your program sustainable and innovative to better support patients? Accumulators, maximizers, AFPs – What are your next steps to ensure effective reimbursement strategies? In an election year, what is the future of health policy? Experts will tackle these questions and more as the industry comes together to benchmark best practices to accelerate access and commercialization. Do not miss your chance to join seasoned leaders, your peers and leading solution providers as they navigate marketplace trends and dive into the impact coupons, benefit design, accumulators, maximizers, alternative funding programs and drug pricing legislation have on patient affordability and out-of-pocket costs. This is your chance to gain critical insights on industry standards, forward-thinking strategies to optimize your copay and cost sharing programs and so much more. Content highlights: Over 20 hours of content, including 7+ dedicated sessions to help decipher copay legislation Crucial perspectives from Pfizer, Sanofi, Janssen, Teva, Ascendis Pharma, Melinta Therapeutics, GSK, HIV + Hepatitis Policy Institute and more Insights direct from enforcement agents on the top trends and actions within the copay and patient services space Illuminating case study, Navigating the Patient Journey in a Shifting Copay Landscape from Spark Therapeutics 465 minutes of valuable in-person networking with colleagues and counterparts to expand your network and establish powerful partnerships Additional content access through Streamly, a platform that gives you 12-month access to all of the available conference content** to review at your leisure And more! Download the agenda and register today—Be sure to use your exclusive promo USAVE24 to save 10% off* of your registration See you there! *Cannot be combined with other offers, promotions or applied to an existing registration. Other restrictions may apply. **Pending speaker permissions The content of Sponsored Posts does not necessarily reflect the views of HMP Omnimedia, LLC, Drug Channels Institute, its parent company, or any of its employees. To find out how you can promote an event on Drug Channels, please contact Paula Fein (paula@DrugChannels.net). Full Article Sponsored Post
men Another IRA Surprise: Part B Coinsurance Inflation Adjustments Are Increasing Patient Costs (rerun) By feeds.feedblitz.com Published On :: Thu, 03 Oct 2024 10:30:00 +0000 This week, I’m rerunning some popular posts while we put the finishing touches on DCI’s new 2024-25 Economic Report on Pharmaceutical Wholesalers and Specialty Distributors. The article below highlights an underappreciated consequence of the Inflation Reduction Act’s inflation rebates for Medicare Part B drugs. Last night, I posted an updated analysis showing that the volatility in seniors' coinsurance rates continues. For the fourther quarter of 2024, coinsurance rates for 51 drugs increased, while rates for only 19 drugs decreased. What's more, rates for 17 drugs returned to their original 20% level. Click here to see our original post from May 2024. Contrary to what you may have heard, the Inflation Reduction Act’s (IRA) inflation rebates for Medicare Part B drugs do not always save money for seniors. As we document below, a growing share of Part B drugs have inflation-adjusted coinsurance rates that have been increasing, not declining. In many cases, the coinsurance rate declines only briefly before rebounding back to the standard 20% rate. What’s more, these fluctuations have triggered huge jumps in patients’ out-of-pocket obligations for some drugs—even when a drug’s costs were falling. Chalk off these coinsurance surprises to yet another unintended consequence of the IRA. Seniors who are expecting to see costs drop may find they are instead being taken for a rollercoaster ride. Read more » Full Article Average Sales Price (ASP) Buy-and-Bill Costs/Reimbursement Inflation Reduction Act of 2022
men Drug Channels News Roundup, October 2024: Humira Price War Update, PA vs. Providers, IRA vs. Physicians, My AI Podcast, New DCI Jobs, and Dr. G on Copayments By feeds.feedblitz.com Published On :: Tue, 29 Oct 2024 10:30:00 +0000 Eeek! It's time for Drug Channels’ Halloween roundup of terrifying tales to share with your ghoulish fiends. This month’s tricks and treats: Spooky! Blue Shield of California frightens away the gross-to-net bubble with its Humira biosimilar strategy Vampiric! Prior authorization sinks its fangs into providers’ time Wicked! How the IRA will put a stake through specialty physician practices Eerie! Google’s monstrous AI podcasts leave me petrified Zoinks! Join the vampire hunters at Drug Channels Institute Plus, Dr. Glaucomflecken tells us a frightening tale of copayments. P.S. Stretch out your arms and join the ever-growing zombie horde who shamble after me on LinkedIn. You’ll find my ghostly rantings along with commentary from the undead hordes in the DCI community. Read more » Full Article Average Sales Price (ASP) Biosimilars Buy-and-Bill Gross-to-Net Bubble Inflation Reduction Act of 2022 PBMs Physicians
men How Field Reimbursement Services Help Overcome Coverage Barriers and Improve Patient Outcomes By feeds.feedblitz.com Published On :: Fri, 01 Nov 2024 11:00:00 +0000 Today’s guest post comes from Kimberley Chiang, Vice President of Biopharma Commercial Solutions at CoverMyMeds Kimberley highlghts the crucial roles of field reimbursement managers in removing access and reimbursement barriers. She then identifies the keys to successful implementation of field reimbursement services. To learn more, register for CoverMyMeds' November 13, 2024, webinar: Specialty Therapies & Field Reimbursement Services: Driving Better Outcomes for Brands and Patients. Read on for Kimberley’s insights. Read more » Full Article Guest Post Sponsored Post
men ¿Cómo aprueba la FDA los medicamentos nuevos? By www.flickr.com Published On :: Mon, 12 Aug 2024 11:55:27 -0700 The U.S. Food and Drug Administration posted a video: Los medicamentos de receta pasan por muchos pasos y fases importantes antes de que los aprobemos. Las investigaciones, los datos y la evidencia deben demostrar que el medicamento es seguro y eficaz para el uso previsto. Aprenda más sobre el proceso de aprobación de la FDA de principio a fin. Para obtener más información sobre el papel de la FDA en la regulación y la aprobación de medicamentos, visite nuestro sitio web en www.fda.gov/drugs/information-consumers-and-patients-drug... Vea esta serie de tres partes: www.youtube.com/playlist?list=PL0AE2C851E6968546 Full Article
men ¿Cuál es el papel de la FDA en la regulación de los medicamentos? By www.flickr.com Published On :: Mon, 12 Aug 2024 11:55:27 -0700 The U.S. Food and Drug Administration posted a video: Quizás sepa que la FDA es responsable de aprobar los medicamentos nuevos, como medicamentos de receta, genéricos, biosimilares y de venta libre, y de garantizar que esos medicamentos sean seguros, de alta calidad y funcionen como se supone que deben hacerlo. Pero nuestro trabajo no termina ahí. Continuamos monitoreando la seguridad y calidad de los medicamentos aprobados en los años venideros. Aprenda más sobre nuestro papel en la regulación de estos medicamentos. Para obtener más información sobre el papel de la FDA en la regulación y la aprobación de medicamentos, visite nuestro sitio web en www.fda.gov/drugs/information-consumers-and-patients-drug... Vea esta serie de tres partes: www.youtube.com/playlist?list=PL0AE2C851E6968546 Full Article
men Medicamentos biosimilares: Lo que los pacientes deben saber By www.flickr.com Published On :: Mon, 12 Aug 2024 11:55:28 -0700 The U.S. Food and Drug Administration posted a video: ¿Qué son los biosimilares? Los biosimilares son un tipo de medicamento que se usa para tratar una variedad de afecciones, como enfermedades crónicas de la piel y los intestinos, artritis, diabetes, afecciones renales, degeneración macular y algunos tipos de cáncer. Un biosimilar es un tipo de medicamento biológico. La mayoría de los medicamentos biológicos se elaboran usando fuentes vivas, como células animales, bacterias o levaduras. Debido a que en su mayoría provienen de fuentes vivas, todos los tipos de productos biológicos tienen diferencias menores que ocurren naturalmente entre los lotes de producción. Así como los medicamentos de marca tienen versiones genéricas, los biológicos originales pueden tener biosimilares. La cuidadosa revisión de datos, estudios y pruebas por parte de la FDA ayuda a garantizar que los productos biosimilares brinden los mismos beneficios de tratamiento que el producto biológico original aprobado por la FDA. Los biosimilares pueden brindarle más acceso a tratamientos importantes y también pueden ahorrarle dinero, dependiendo de su cobertura de seguro. Se han aprobado muchos biosimilares diferentes y se esperan aún más. Para obtener más información, visite www.fda.gov/biosimilars Full Article
men ¿Qué hace la FDA después de que aprueba los medicamentos? By www.flickr.com Published On :: Mon, 12 Aug 2024 11:55:28 -0700 The U.S. Food and Drug Administration posted a video: La FDA monitorea continuamente datos en tiempo real de pacientes, fabricantes de medicamentos y profesionales de la salud, incluyendo informes de reacciones adversas a los medicamentos de receta. Según estos datos, podemos actualizar las etiquetas de los medicamentos o, en casos excepcionales, solicitar la retirada del mercado. Aprenda más sobre el proceso de la FDA para el monitoreo continuo de los medicamentos aprobados. Para obtener más información sobre el papel de la FDA en la regulación y la aprobación de medicamentos, visite nuestro sitio web en www.fda.gov/drugs/information-consumers-and-patients-drug... Vea esta serie de tres partes: www.youtube.com/playlist?list=PL0AE2C851E6968546 Full Article
men ¿Cuál es el papel de la FDA en la regulación de los medicamentos? (30 segundos) By www.flickr.com Published On :: Tue, 13 Aug 2024 12:15:55 -0700 The U.S. Food and Drug Administration posted a video: Quizás sepa que la FDA es responsable de aprobar los medicamentos nuevos, como medicamentos de receta, genéricos, biosimilares y de venta libre, y de garantizar que esos medicamentos sean seguros, de alta calidad y funcionen como se supone que deben hacerlo. Pero nuestro trabajo no termina ahí. Continuamos monitoreando la seguridad y calidad de los medicamentos aprobados en los años venideros. Aprenda más sobre nuestro papel en la regulación de estos medicamentos. Para obtener más información sobre el papel de la FDA en la regulación y la aprobación de medicamentos, visite nuestro sitio web en www.fda.gov/drugs/information-consumers-and-patients-drug... Full Article
men ¿Cómo aprueba la FDA los medicamentos nuevos? (30 segundos) By www.flickr.com Published On :: Tue, 13 Aug 2024 12:19:23 -0700 The U.S. Food and Drug Administration posted a video: Los medicamentos de receta pasan por muchos pasos y fases importantes antes de que los aprobemos. Las investigaciones, los datos y la evidencia deben demostrar que el medicamento es seguro y eficaz para el uso previsto. Aprenda más sobre el proceso de aprobación de la FDA de principio a fin. Para obtener más información sobre el papel de la FDA en la regulación y la aprobación de medicamentos, visite nuestro sitio web en www.fda.gov/drugs/information-consumers-and-patients-drug... Full Article
men ¿Qué hace la FDA después de que aprueba los medicamentos? (30 segundos) By www.flickr.com Published On :: Tue, 13 Aug 2024 12:23:26 -0700 The U.S. Food and Drug Administration posted a video: La FDA monitorea continuamente datos en tiempo real de pacientes, fabricantes de medicamentos y profesionales de la salud, incluyendo informes de reacciones adversas a los medicamentos de receta. Según estos datos, podemos actualizar las etiquetas de los medicamentos o, en casos excepcionales, solicitar la retirada del mercado. Aprenda más sobre el proceso de la FDA para el monitoreo continuo de los medicamentos aprobados. Para obtener más información sobre el papel de la FDA en la regulación y la aprobación de medicamentos, visite nuestro sitio web en www.fda.gov/drugs/information-consumers-and-patients-drug... Full Article
men FDA’s Indifferent Attitude Towards the First Amendment By www.fdamatters.com Published On :: Mon, 01 Apr 2013 17:09:04 +0000 The FDA doesn’t care about the First Amendment rights of the companies it regulates. It cares even less about the “free speech” rights of those companies’ sales and marketing representatives. And why should the agency care? One of FDA’s primary missions is to protect the public health and safety of the American people from illegal, adulterated and misbranded products. Doing so involves restraining food, drug, device and cosmetics companies from committing fraudulent and deceptive acts that are not protected by companies’ commercial free speech rights. Nonetheless, FDA Matters envisions opportunities for FDA and industry to broaden permissible product communications. The key is understanding history, not constitutional law. Full Article Drug Approval and Access FDA Accountability and Transparency FDA and Industry FDA Leadership Insight on FDA-regulated Industries
men EMA recommends approval of aflibercept biosimilars Afqlir and Opuviz By www.gabionline.net Published On :: Wed, 23 Oct 2024 08:39:24 +0000 <p>On 19 September 2024, the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion, recommending the granting of marketing authorization for two aflibercept biosimilars: Sandoz’s Afqlir and Samsung Bioepis’s Opuviz. These products are biosimilars of the reference product Eylea, developed by Regeneron and Bayer.</p> Full Article