Valuecom Evidence Based Solutions

#ICYMI: 📣Join FDA and Clinical Trials Transformation Initiative (CTTI) August 6, 2024 (10:00 AM - 5:30 PM EDT) for a free hybrid public workshop on artificial intelligence (AI) in drug and biological product development. Please join us as we explore the guiding principles being applied by innovators and regulators to ensure AI is used responsibly. AI holds great potential to transform how drugs are developed, manufactured, and used. Register today ➡️ https://lnkd.in/eP99VH_2

Today, FDA issued a draft guidance to assist medical product sponsors in submitting Diversity Action Plans to support certain clinical studies. Diversity Action Plans are intended to increase clinical study enrollment of participants of historically underrepresented populations to help improve the data the agency receives about the patients who may potentially use the medical product. https://lnkd.in/eT5AhNTP

📢 Just published - new guidance for medical devices used in combination with medicines 💉 💊 🤝 The document will guide marketing authorisation holders, applicants and notified bodies through some of the changes introduced by the medical devices and in-vitro diagnostics regulations. 🔍 What's inside: ➡ insights on integral drug-device combinations and their lifecycle management ➡ labelling requirements for medical devices co-packaged with medicinal products ➡ information on the consultation procedures for medical devices with ancillary medicinal substances and companion diagnostics Find out more: https://lnkd.in/d6wjy5KN #medicines #MedicalDevices #InVitroDiagnostics #CompanionDiagnostics

#ICYMI: View the recordings from the Integrated Safety Analyses in Drug Marketing Applications: Avoiding Common Mistakes webinar to learn how and when to work with FDA to improve your integrated safety analyses and obtain answers to questions you may have about your application. View the recordings here ➡ https://lnkd.in/eBJNg82z

FDA approved Yesafili (aflibercept-jbvf) and Opuviz (aflibercept-yszy) as interchangeable biosimilars to Eylea (aflibercept) to treat: o Neovascular (wet) age-related macular degeneration o Macular edema following retinal vein occlusion o Diabetic macular edema o Diabetic retinopathy The risks included as contraindication or under the warnings and precautions include: o Hypersensitivity o Endophthalmitis (inflammation of the vitreous humor and surrounding tissues), retinal detachments, and retinal vasculitis with or without occlusion o Increase in intraocular pressure o Thromboembolic events (blood clots)

Another initiative supporting Digital India and Female health in India under the Ayushman Bharat scheme by Government of India: Abha https://lnkd.in/gTycnMcM Happy Mother's Day to all the beautiful Mother's around the world!!

Another initiative supporting Digital India and Female health in India under the Ayushman Bharat scheme by Government of India: Abha https://lnkd.in/gTycnMcM Happy Mother's Day to all the beautiful Mother's around the world!!

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People at high risk of severe COVID-19 may benefit after final guidance recommending remdesivir was issued today. The antiviral medicine is given as an infusion through a drip, once a day for 3 days. Remdesivir is recommended as an option for treating COVID‑19 in hospitals. Learn more: https://lnkd.in/eRpKdvUQ ?utm_medium=social&utm_source=linkedin&utm_campaign=id6261_080524&utm_term=guidance&utm_content=graphic #NICENews

FACT CHECK !!!!!! The emergence of Thrombosis with Thrombocytopenia Syndrome (TTS) as a potential rare side effect associated with the Covishield vaccine, developed by AstraZeneca, has understandably raised concerns among the public. TTS is a serious condition characterized by blood clot formation coupled with low platelet count, which can lead to severe complications if not promptly treated. However, it's important to put this risk into perspective. While TTS is a serious condition, it is extremely rare, with reported cases occurring in a very small fraction of individuals who have received the Covishield vaccine. The reported incidence of TTS following Covishield vaccination is approximately 3 in 1,00,000 doses administered. Moreover, TTS tends to occur within a specific timeframe after vaccination, typically within 4 to 42 days post-vaccination. In light of these considerations, it's crucial to conduct a balanced risk-benefit analysis. The benefits of vaccination, particularly in mitigating the spread of COVID-19 and preventing severe illness and death, overwhelmingly outweigh the risks associated with rare side effects like TTS. Mass vaccination campaigns, including the administration of Covishield, have played a pivotal role in controlling the pandemic and saving lives globally. It's also important to emphasize that regulatory agencies and health authorities closely monitor vaccine safety and effectiveness. Any reports of adverse events, including TTS, are thoroughly investigated to assess causality and inform public health decisions. Additionally, healthcare providers are trained to recognize and manage potential vaccine-related complications, ensuring prompt intervention if necessary. While concerns about vaccine safety are understandable, it's essential to rely on evidence-based information and expert guidance when making decisions about vaccination. Individuals with specific health concerns or risk factors should consult with their healthcare providers to weigh the benefits and risks of vaccination in their particular circumstances. In conclusion, while the potential risk of TTS associated with the Covishield vaccine should not be dismissed, it should be considered in the broader context of the significant benefits of vaccination in combating the COVID-19 pandemic. Continued vigilance, transparency, and communication are essential to maintain public trust and confidence in vaccination efforts. #covishield #vaccine