Society for Cardiovascular Angiography & Interventions’ Post

An interesting deficiency case where how indications statement is written affected the required clinical evidence. Read the document below for the insight! #mdr #indications #clinicalevidence

"Accelerated approval allows the FDA to rely on surrogate or intermediate clinical endpoints to approve therapies in a shorter time frame than would be possible with traditional endpoints, but it has come under scrutiny by some policymakers and researchers in recent years." Rachel Dolan of PhRMA and Tiernan Meyer of Avalere explain in their article featured in the latest issue of Med Ad News. https://lnkd.in/eGE2cjP2 #FDA #payers #acceleratedapproval #patientaccess #regulatorypathway

Which are valid adverse event reports? 💡 ✏️ The minimum dataset required to consider information as a reportable AE is indeed minimal, namely (1) an identifiable patient, (2) an identifiable reporter, (3) product exposure, and (4) an event. However, in addition to direct data collection, AEs can be detected through retrospective analysis of a population database, where direct patient or health care provider contact does not occur. Patient interactions include clinical interactions and data collection by phone, Internet, or other means; perusal of electronic medical records or insurance claims data would not be considered direct patient interaction. Reporting is rarely required for individual AEs observed in aggregate population data, since there is no direct patient interaction where an association might be suggested or inferred. Nevertheless, if aggregate or epidemiologic analyses suggest that an AE is associated with exposure to a drug or medical product, it is desirable that the minimum dataset information be forwarded to the manufacturer of the product, who will determine any need for, and timing of, reporting of study results to the relevant regulatory authorities.

Does your pharmacy struggle with denial management? Don't have the time to wade through spreadsheets looking for underlying root causes that have broad impact? The DetectRx Pre and Post Edit solution includes our Denial Management Insights reporting, which provides a meaningful visual analysis of your rejection data so that you can easily identify core issues. #veridikal #denialmanagement #pharmacydata

Pain doctors, ready to save more and increase revenue? Join INJX for exclusive pricing tailored to your practice. Maximize efficiency and elevate patient care with zero fees and no long-term commitments. Take control of your practice’s growth— visit injxgpo.com to apply today! #INJX #GPO #PainManagement

The progress towards precision medicine continues to show promise as more states approve universal coverage or pharmacogenomics (PGx) testing! As of July 1, California joins 13 other states aligning with Medicare coverage in place since 2020. Along with dosing mistakes that cause toxicity and fatalities, this will help curb the annual loss of 33,000 lives and 62 billion dollar spend due to non-optimized medications in the state. DoseMe shares the mission to help patients access personalized care, but the work is not over until similar efforts move forward in every state and nationally. Please see where your state stands in moving biomarker legislation forward and join the efforts if needed - https://lnkd.in/gwgcHA8Q. And support national efforts to reduce adverse drug events by asking your Congressional representatives to support the Right Drug Dose Now Act of 2024 - https://lnkd.in/dAf--N7p. #pharmacogenomics #PGX #medicare #insurance #precisiondosing

Plan sponsors may consider a data-driven approach to predict and manage conditions that lead to the most expensive claims. Predictive models that use advanced machine learning algorithms have shown promise in reducing risk in the health care system and may be useful in identifying and managing such conditions via workplace benefit plans. #innovation #management #creativity #future #futurism #motivation #personaldevelopment #sustainability #leadership #careers #insurance #insured #sales #business #rates #renewals #Q4 #fourthquarter #businessowner #advice #consulting #savings #cost #flexibility #ACA #reporting #reports #salary #disease #program #prevention

MAIA reporting automates and simplifies mandatory #lifesciencesreporting functions - including CSR, DSUR, TLF, and more – using a powerful combination of #genAI and human-in-the-loop presence. It’s past time to reclaim lost time and focus on what matters most: serving patients. Visit https://lnkd.in/eAXbX6hG #lifesciencesAI #lifesciences compliance #healthcarecompliance

CASE STUDY—We helped a client determine the human abuse potential of their novel neuropathic pain medication with a multi-study program, delivering robust data for their regulatory submissions. We review this study on our blog. Read it here: https://lnkd.in/dsjgbsQy #DrugDevelopment #ClinicalTrials #Analgesic

Nine months ago, I embarked on a mission to create an app aimed at combating overdose fatalities. 📱 Despite increased access to naloxone, fatal overdoses persist, especially when users are alone and unable to self-administer the life-saving medication. The idea was simple: users set a timer, and if left unanswered, an SOS would be triggered automatically. ⏰ However, I've hit the pause button on further development. Why? 🤔 In the fast-paced world of tech, it's all about 'learn fast and learn cheap.' Two game-changing developments caught my eye: 1. Google Pixel's SMS app, Google Messages, now offers scheduled text messages, providing a nifty workaround to our app's core function. 2. Celero Systems is revolutionizing healthcare with RESCUE-Rx, a weekly digital pill that detects distress and administers medication automatically. 🩺 I'm excited to witness the development of Celero's RESCUE-Rx. It's not just about overdose prevention—it's a glimpse into the future of healthcare technology. 🚀 As we embrace these advancements, we pave the way for a healthier, safer tomorrow. #OverdosePrevention #DigitalHealth #HealthcareRevolution