med Mohammed Shami's return date announced as Gautam Gambhir, Rohit Sharma heave huge sigh of relief ahead of BGT - Hindustan Times By news.google.com Published On :: Wed, 13 Nov 2024 00:41:00 GMT Mohammed Shami's return date announced as Gautam Gambhir, Rohit Sharma heave huge sigh of relief ahead of BGT Hindustan Times"360 Days Is A...": Mohammed Shami Posts Picture From Airport. Ex-India Star Says "Brother..." NDTV SportsLive Cricket Update - GOA vs ARP Plate Group - Ranji Trophy blog: Round 5, day 1: Shami set for return in Indore ESPNcricinfoMohammed Shami makes Ranji Trophy comeback, plays first match with brother Kaif for Bengal The Indian ExpressRanji Trophy: Double delight for Mohammed Shami on comeback as brother Kaif named in Bengal playing XI ag The Times of India Full Article
med ‘Vijay 69’ movie review: Anupam Kher takes a dip in the channel of mediocrity By www.thehindu.com Published On :: Fri, 08 Nov 2024 16:19:36 +0530 Promising to be inspiring, ‘Vijay 69’ turns out like a mildly entertaining episode in Anupam Kher’s popular play, ‘Kucch Bhi Ho Sakta Hai’ Full Article Movies
med Mohanlal - Shobana’s film helmed by Tharun Moorthy titled ‘Thudarum’ By www.thehindu.com Published On :: Sat, 09 Nov 2024 16:08:20 +0530 The supporting cast ‘Thudarum’ includes Binu Pappu, Maniyanpilla Raju, Farhaan Faasil, and Thomas Mathew Full Article Movies
med Neil Simon’s vintage comedy ‘The Odd Couple’ returns to Bengaluru’s theatre By www.thehindu.com Published On :: Mon, 11 Nov 2024 12:29:28 +0530 Ajai Kesavan’s The Odd Couple attempts to bring laughter and nostalgia to Bengaluru with a fresh take on Neil Simon’s beloved comedy about unlikely roommates Full Article Theatre
med Kleinman Says 'Open Your Eyes,' Not Tamed... By www.msn.com Published On :: 2024-11-13T06:19:36Z Kleinman Says 'Open Your Eyes,' Not Tamed... (First column, 13th story, link) Related stories:Summers sounds alarm bell on inflation... Full Article
med Former Salesforce president named Amperity CEO By www.bizjournals.com Published On :: Tue, 12 Nov 2024 22:25:31 +0000 He replaces interim CEO Chris Jones, who had been filling in since the previous CEO stepped down in June. Full Article
med LabX Media Group Acquires Discover Magazine, Expanding its Reach in Science Media By www.discovermagazine.com Published On :: Fri, 08 Nov 2024 15:00:00 GMT The addition of Discover to LabX’s portfolio strengthens its position as a leading voice in science and research media, bringing one of the most recognized science publications into its family. Full Article The Sciences
med Netflix announces new Japanese family drama ‘Asura’ helmed by Palme d’Or-winner By www.independent.co.uk Published On :: 2024-11-12T09:20:21+00:00 The show will premiere in January 2025 Full Article News TV & Radio Culture
med Israeli strikes kill dozens in the Gaza Strip and Lebanon, medics say By www.npr.org Published On :: Wed, 13 Nov 2024 01:26:41 -0500 Israeli airstrikes killed at least 46 people in the Gaza Strip in the past day, medics said. In Lebanon, warplanes struck Beirut's southern suburbs and killed 33 people in the country on Tuesday. Full Article
med Fujifilm is developing a 102MP medium format cinema camera By www.engadget.com Published On :: Tue, 12 Nov 2024 13:00:27 +0000 Fujifilm is developing a medium-format, 102-megapixel cinema camera, the company said in a surprise announcement. Due next year, the GFX Eterna will carry a boxy, modular design reminiscent of Sony's FX6 or the new Blackmagic Pyxis and will likely be launched with a top handle, electronic viewfinder and other optional accessories. The new camera will have a medium format GFX 102-megapixel (MP) CMOS II HS sensor, the same one used on the GFX100 II. That sensor is 43.8mm x 32.9 mm in size, or 1.7 times larger than the full-frame sensor found on the aforementioned FX or Pyxis. That will be one of the largest cinema camera sensors available, even bigger than RED's V-Raptor XL sensor. The benefits will be extra dynamic range, potentially high resolution and a very shallow depth of field that should allow for cinematic shots when paired with the right lens. That does bring up the fact that Fujifilm currently has no GFX glass designed specifically for film production. However, the company said it's developing a 32-90mm power zoom lens (24-70mm full-frame equivalent) and will have a mount adapter for GFX to PL lenses, which are widely used in cinema. One other concern might be rolling shutter distortion. RED's V-Raptor XL uses a global shutter that has zero distortion, but the sensor Fujifilm will employ has a fair bit of it . In addition, the GFX100 II captures 8K with a 1.53x crop, negating many of the benefits of a medium format sensor — so, hopefully Fujifilm will resolve those issues with its cinema camera. Fujifilm will show off the GFX Eterna starting tomorrow at the InterBEE 2024 media exhibition in Chiba City, Japan. It's set to be released sometime in 2025, with an exact date and pricing yet to be announced.This article originally appeared on Engadget at https://www.engadget.com/cameras/fujifilm-is-developing-a-102mp-medium-format-cinema-camera-130027537.html?src=rss Full Article Cameras & Photography site|engadget provider_name|Engadget region|US language|en-US author_name|Steve Dent
med Spread of dengue fever in Bangladesh worries medics By www.terradaily.com Published On :: Wed, 13 Nov 2024 05:57:03 GMT Dhaka (AFP) Nov 7, 2024 Bangladesh is struggling to tamp down a surge in dengue cases as climate change turns the disease into a year-round crisis, leaving some paediatric wards packed with children squeezed two to a bed. The Aedes mosquito that spreads dengue - identifiable by its black and white striped legs - breeds in stagnant pools, and cases once slowed after the monsoon rains faded. "Normally, around t Full Article
med Border agency clears employee after Indian media reports link him with terrorism By www.cbc.ca Published On :: Tue, 12 Nov 2024 17:00:00 EST A Canada Border Services Agency superintendent is speaking out after being targeted by the Indian government with allegations of murder and terrorism — allegations Canadian authorities say are not backed by any evidence. Full Article News/Politics
med Le film «Monsieur Aznavour» présenté à Montréal samedi: une première «symbolique» pour le réalisateur Grand Corps Malade By www.journaldemontreal.com Published On :: Fri, 08 Nov 2024 19:00:00 EST Gros succès en France, le drame biographique est présenté samedi au Festival Cinemania. Full Article
med AIOCD urges DCGI to immediately stop partnership between Swiggy & PharmEasy for rapid drug delivery By www.pharmabiz.com Published On :: Friday, November 8, 2024 08:00 IST Raising deep concern over the partnership between Swiggy Instamart and PharmEasy for a rapid drug delivery model, the All India Organization of Chemists and Druggists (AIOCD) has apprised the Drug Controller Full Article
med Indian health, pharma companies invited to participate in Iraq's 'Medico Expo' from Feb 5─8, 2025 By www.pharmabiz.com Published On :: Friday, November 8, 2024 08:00 IST The Embassy of India in Iraq has extended an invitation to Indian businesses to participate in the "Medico Expo," officially known as the Erbil International Health Exhibition. This prestigious event, set to be the Full Article
med 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
med DoP releases operational guidelines for Strengthening of Medical Device Industry scheme By www.pharmabiz.com Published On :: Tuesday, November 12, 2024 08:00 IST The Department of Pharmaceuticals (DoP) has released the operational guidelines for the newly announced central sector scheme for Strengthening of Medical Device Industry (SMDI), aiming at providing Full Article
med Industry hails DoP's new scheme for strengthening of medical devices industry By www.pharmabiz.com Published On :: Wednesday, November 13, 2024 08:00 IST The centrally sponsored scheme for strengthening of medical devices industry (SMDI), launched by the Central government last week, was widely welcomed by the medical devices industry in the country. Full Article
med NABL announces joint technical training programme with MANTRA on medical textiles testing By www.pharmabiz.com Published On :: Wednesday, November 13, 2024 08:00 IST The National Accreditation Board for Testing and Calibration Laboratories (NABL), under the Quality Council of India (QCI), has announced a collaborative effort with Man─Made Textile Research Association (MANTRA) in Surat to deliver a specialized technical training programme on medical textiles testing. Full Article
med Asahi Kasei Medical launches Planova FG1 next-generation virus removal filter By www.medicalplasticsnews.com Published On :: Wed, 30 Oct 2024 15:30:00 -0000 Asahi Kasei Medical has launched the Planova FG1, a next-generation virus removal filter featuring higher flux for the manufacture of biotherapeutics, in October 2024. Full Article
med Nvision Biomedical 3D-printed PEEK Interbody System receives FDA clearance By www.medicalplasticsnews.com Published On :: Thu, 31 Oct 2024 12:00:00 -0000 Nvision Biomedical Technologies and Invibio Biomaterial Solutions have announced that the FDA has granted clearance of the first 3D-Printed PEEK Interbody System made from PEEK-OPTIMA. Full Article
med Placon announces new stock medical line of pouches and tip protectors By www.medicalplasticsnews.com Published On :: Thu, 31 Oct 2024 13:30:00 -0000 Placon, an innovator in the medical packaging market, announced the release of a new stock line of BargerGard TPU pouches and tip protectors. Full Article
med TekniPlex Healthcare to debut strong paper for medical packaging at Pack Expo By www.medicalplasticsnews.com Published On :: Fri, 01 Nov 2024 10:00:00 -0000 TekniPlex Healthcare is set to unveil its strongest-ever reinforced paper for medical device packaging applications at Pack Expo 2024, 3-6 November in Chicago. Full Article
med WITTMANN BATTENFELD presents latest technology at Compamed By www.medicalplasticsnews.com Published On :: Fri, 01 Nov 2024 12:00:00 -0000 WITTMANN BATTENFELD will present the latest solutions for time and cost optimisation in the production of parts with nano structures at Compamed, booth No. F03-1 in hall 8b. Full Article
med PolyNovo to exhibit at MEDICA 2024 with Medilink UK By www.medicalplasticsnews.com Published On :: Fri, 01 Nov 2024 14:30:00 -0000 PolyNovo UK – a UK medical devices company specialising in the development of surgical solutions using the patented polymer technology NovoSorb will be exhibiting at MEDICA 2024. Full Article
med Schultz Medical to exhibit at MEDICA 2024 with Medilink UK By www.medicalplasticsnews.com Published On :: Tue, 05 Nov 2024 12:00:00 -0000 Schultz Medical, a single use instrument company based in Southport, Merseyside have announced they will be exhibiting at MEDICA 2024 in Germany and on the UK Pavilion in Hall 15 hosted by Medilink UK. Full Article
med UK HealthTech on full display at ABHI UK pavilion For MEDICA 2024 By www.medicalplasticsnews.com Published On :: Tue, 05 Nov 2024 14:30:00 -0000 The Association of British HealthTech Industries (ABHI) is excited to unveil a diverse delegation of UK HealthTech innovators at MEDICA 2024, one of the world's largest and most influential medical trade fairs. Full Article
med Q&A: Bringing sustainability into the medical industry By www.medicalplasticsnews.com Published On :: Tue, 05 Nov 2024 16:00:00 -0000 Brightmark CEO Bob Powell discusses Plastics Renewal technology and how to bring sustainability into the medical industry. Full Article
med Ampacet ProVital+ Gamma-Protect preserves polypropylene-based medical plastics during sterilisation process By www.medicalplasticsnews.com Published On :: Tue, 05 Nov 2024 16:19:16 -0000 Ampacet has introduced ProVital+ Gamma-Protect, a medical-grade additive designed to preserve mechanical and optical properties of polypropylene-based medical and pharmaceutical articles during gamma and e-beam sterilisation processes. Full Article
med Accumold showcases micromoulding innovation at Compamed By www.medicalplasticsnews.com Published On :: Wed, 06 Nov 2024 12:00:00 -0000 Accumold, with over 40 years of experience in micromoulding technology, is set to participate at Compamed, taking place in Düsseldorf, Germany, from 11-14 November. The company will highlight its small and complex parts for medical device OEMs. Full Article
med LFH Regulatory to attend MEDICA to provide guidance on navigating markets By www.medicalplasticsnews.com Published On :: Wed, 06 Nov 2024 15:30:00 -0000 Regulatory experts LFH Regulatory have announced their attendance at MEDICA 2024 to provide insights and support to healthcare innovators facing the complexities of the UK and EU markets. Full Article
med Protecting vital medical implants with epoxies By www.medicalplasticsnews.com Published On :: Wed, 06 Nov 2024 17:00:00 -0000 Mike Hodgin, director of strategic applications, Meridian Electronics Division discusses enabling and protecting vital medical implants with epoxies. Full Article
med Surgical Holdings attends MEDICA 2024 By www.medicalplasticsnews.com Published On :: Thu, 07 Nov 2024 11:00:00 -0000 Surgical Holdings, a British manufacturer and repairer of medical devices, will return to MEDICA 2024 for the third consecutive year, focused on strengthening its partnerships across Europe and expanding its reach in key markets. Full Article
med Syensqo to showcase portfolio of medical-grade polymers at Compamed By www.medicalplasticsnews.com Published On :: Thu, 07 Nov 2024 13:30:00 -0000 Syensqo, previously part of Solvay Group and a global provider of advanced performance materials and chemical solutions, is making its debut at Compamed 2024. Full Article
med 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
med Trelleborg Medical Solutions showcases polymer-based solutions at Compamed By www.medicalplasticsnews.com Published On :: Mon, 11 Nov 2024 10:00:00 -0000 Trelleborg Medical Solutions showcases its comprehensive polymer-based solutions and capabilities for the medical technology and biopharmaceutical industries at Compamed 2024 in Dusseldorf from November 11 to 14, at stand F02 in hall 8A. Full Article
med Astrology Was an Important Science for Medieval People By www.scientificamerican.com Published On :: Wed, 06 Nov 2024 11:00:00 +0000 In medieval times, astrology was considered a serious science, a branch of astronomy. Curator Larisa Grollemond of the Getty Museum, walks us through the medieval zodiac and how someone’s sign decided their day-to-day life. Full Article
med Plant-Based Soft Medical Robots By www.medgadget.com Published On :: Mon, 11 Dec 2023 16:00:29 +0000 Researchers at the University of Waterloo in Canada have developed plant-based microrobots that are intended to pave the way for medical robots that can enter the body and perform tasks, such as obtaining a biopsy or performing a surgical procedure. The robots consist of a hydrogel material that is biocompatible and the composite contains cellulose […] Full Article Materials Medicine Surgery UWaterloo WaterlooENG
med ¿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
med ¿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
med 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
med ¿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
med ¿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
med ¿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
med ¿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
med Former CHC Board Chairs Sharon Callahan and Nick Colucci Named as 2025 MAHF Inductees By cohealthcom.org Published On :: Fri, 25 Oct 2024 20:39:55 +0000 Two former board chairs of the Coalition for Healthcare Communication (CHC) were named as the Medical Advertising Hall of Fame (MAHF) 2025 inductees – Sharon Callahan, former Chief Client Officer at Omnicom Health Group (OHG), and Nick Colucci, former Chairman and CEO of Publicis Health/COO of Publicis Groupe North America. The inductees will be honored […] Full Article CHC News chc MAHF Nick Colucci Sharon Callahan
med Don’t Confuse the Art and Science of Medicine: PCI vs CABG for Left Main Disease By www.cardiobrief.org Published On :: Thu, 20 Aug 2020 15:56:47 +0000 It is often said that medicine is both an art and a science. In an imperfect world this is both inevitable and desirable. But it is extremely important that the two should not be confused with each other. In particular, because the “science” side of the equation has achieved overwhelming prestige and authority, it is...Click here to continue reading... Full Article Interventional Cardiology & Surgery People Places & Events Policy & Ethics CABG guidelines left main disease LMCA PCI
med Medicines for Europe 23rd Regulatory Affairs Conference 2025 By www.gabionline.net Published On :: Tue, 05 Nov 2024 09:04:58 +0000 <p> <b>23rd Regulatory Affairs Conference 202</b><b>5</b><br /> <b>27</b><b>‒</b><b>28 February 2025</b><br /> Hilton Amsterdam Airport Schiphol<br />Amsterdam, The Netherlands</p> Full Article
med Medicinal Chemistry In The Age Of Artificial Intelligence By lifescivc.com Published On :: Mon, 05 Aug 2024 11:00:53 +0000 By Peter Tummino, CSO of Nimbus Therapeutics, as part of the From The Trenches feature of LifeSciVC “Over the next five to 10 years, our goal is to become a company that’s leading the world in personalized medicines, a company The post Medicinal Chemistry In The Age Of Artificial Intelligence appeared first on LifeSciVC. Full Article Drug discovery From The Trenches R&D Productivity
med Waiver of Informed Consent - proposed changes in the 21st Century Cures Act By www.placebocontrol.com Published On :: Tue, 14 Jul 2015 20:21:00 +0000 Adam Feuerstein points out - and expresses considerable alarm over - an overlooked clause in the 21st Century Cures Act: Waive informed consent requirement for clinical trials?!?! Unbelievable but true if #Path2Cures becomes law. pic.twitter.com/dqmWPpxPdE — Adam Feuerstein (@adamfeuerstein) July 14, 2015 In another tweet, he suggests that the act will "decimate" informed consent in drug trials. Subsequent responses and retweets did nothing to clarify the situation, and if anything tended to spread, rather than address, Feuerstein's confusion. Below is a quick recap of the current regulatory context and a real-life example of where the new wording may be helpful. In short, though, I think it's safe to say: Waiving informed consent is not new; it's already permitted under current regs The standards for obtaining a waiver of consent are stringent They may, in fact, be too stringent in a small number of situations The act may, in fact, be helpful in those situations Feuerstein may, in fact, need to chill out a little bit (For the purposes of this discussion, I’m talking about drug trials, but I believe the device trial situation is parallel.) Section 505(i) - the section this act proposes to amend - instructs the Secretary of Health and Human Services to propagate rules regarding clinical research. Subsection 4 addresses informed consent: …the manufacturer, or the sponsor of the investigation, require[e] that experts using such drugs for investigational purposes certify to such manufacturer or sponsor that they will inform any human beings to whom such drugs, or any controls used in connection therewith, are being administered, or their representatives, that such drugs are being used for investigational purposes and will obtain the consent of such human beings or their representatives, except where it is not feasible or it is contrary to the best interests of such human beings. [emphasis mine] Note that this section already recognizes situations where informed consent may be waived for practical or ethical reasons. These rules were in fact promulgated under 45 CFR part 46, section 116. The relevant bit – as far as this conversation goes – regards circumstances under which informed consent might be fully or partially waived. Specifically, there are 4 criteria, all of which need to be met: (1) The research involves no more than minimal risk to the subjects; (2) The waiver or alteration will not adversely affect the rights and welfare of the subjects; (3) The research could not practicably be carried out without the waiver or alteration; and (4) Whenever appropriate, the subjects will be provided with additional pertinent information after participation. In practice, this is an especially difficult set of criteria to meet for most studies. Criterion (1) rules out most “conventional” clinical trials, because the hallmarks of those trials (use of an investigational medicine, randomization of treatment, blinding of treatment allocation) are all deemed to be more than “minimal risk”. That leaves observational studies – but even many of these cannot clear the bar of criterion (3). That word “practicably” is a doozy. Here’s an all-too-real example from recent personal experience. A drug manufacturer wants to understand physicians’ rationales for performing a certain procedure. It seems – but there is little hard data – that a lot of physicians do not strictly follow guidelines on when to perform the procedure. So we devise a study: whenever the procedure is performed, we ask the physician to complete a quick form categorizing why they made their decision. We also ask him or her to transcribe a few pieces of data from the patient chart. Even though the patients aren’t personally identifiable, the collection of medical data qualifies this as a clinical trial. It’s a minimal risk trial, definitely: the trial doesn’t dictate at all what the doctor should do, it just asks him or her to record what they did and why, and supply a bit of medical context for the decision. All told, we estimated 15 minutes of physician time to complete the form. The IRB monitoring the trial, however, denied our request for a waiver of informed consent, since it was “practicable” (not easy, but possible) to obtain informed consent from the patient. Informed consent – even with a slimmed-down form – was going to take a minimum of 30 minutes, so the length of the physician’s involvement tripled. In addition, many physicians opted out of the trial because they felt that the informed consent process added unnecessary anxiety and alarm for their patients, and provided no corresponding benefit. The end result was not surprising: the budget for the trial more than doubled, and enrollment was far below expectations. Which leads to two questions: 1. Did the informed consent appreciably help a single patient in the trial? Very arguably, no. Consenting to being “in” the trial made zero difference in the patients’ care, added time to their stay in the clinic, and possibly added to their anxiety. 2. Was less knowledge collected as a result? Absolutely, yes. The sponsor could have run two studies for the same cost. Instead, they ultimately reduced the power of the trial in order to cut losses. Bottom line, it appears that the modifications proposed in the 21st Century Cures Act really only targets trials like the one in the example. The language clearly retains criteria 1 and 2 of the current HHS regs, which are the most important from a patient safety perspective, but cuts down the “practicability” requirement, potentially permitting high quality studies to be run with less time and cost. Ultimately, it looks like a very small, but positive, change to the current rules. The rest of the act appears to be a mash-up of some very good and some very bad (or at least not fully thought out) ideas. However, this clause should not be cause for alarm. Full Article 21st Century Cures Act Adam Feuerstein informed consent