"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
Med Ad News’ Post
More Relevant Posts
-
This Week in Drug Pricing: Patient advocate introduces POTUS, P4AD launches new tool to defend Medicare negotiations, and how the Inflation Reduction Act is lowering drug costs for women. Learn more in our Week In Review: https://lnkd.in/eq8cUece
To view or add a comment, sign in
-
Biden's Healthcare Wins vs AI Fear-Mongering Join us as we delve into current healthcare developments under the Biden-Harris administration. From lowering prescription drug costs to the expansion of the Affordable Care Act, discover the real impacts of these policies. We also tackle the controversial use of AI-generated fear-mongering in political campaigns. #HealthcareReform #BidenHarris #AffordableCareAct #Medicare #PrescriptionDrugCosts #PoliticalDiscussion #AIMisuse #FearMongering #SocialPolicy #VeteransCare
To view or add a comment, sign in
-
Several of our public health customers have been sharing success stories with us about how drug checking helped prevent harm or provided insight on a few serious overdose situations. Here are just a couple instances that were shared with us earlier this year including identifying counterfeit hydromorphone: https://lnkd.in/egm2cvPc Drug checking is most impactful when you identify the unexpected in a sample, and in today's landscape, the unexpected is a wide sea of variables. #drugchecking #drugidentification #xylazinetesting #publichealth #harmreduction
To view or add a comment, sign in
-
While cost-sharing can be expressed as a well-intended benefit design, it can negatively affect long-term drug adherence by patients. AMCP supports efforts to reduce out-of-pocket costs where appropriate, including provisions of the Inflation Reduction Act. However, there could be long-term and unintended consequences in reducing premiums, so it is crucial to develop comprehensive and patient-centric solutions to address these issues over time. AMCP, along with our partners, look forward to our continued efforts to address these complex solutions. https://bit.ly/3T6LSFH #drugpricing #healthequity #patientaccess
AMCP CEO Discusses Adherence, Out-of-Pocket Costs, and Concerns over the Inflation Reduction Act
To view or add a comment, sign in
-
Please take a moment to listen to Mary speak about a very important topic #GLP1s have become the #drugclass of choice in the weight loss category. In this MedTalks Minute, hear MedImpact Healthcare Systems, Inc.'s VP of #Clinical Services discuss the current landscape of these popular drugs. Stay tuned for Part Two to hear what #payers need to know! #wearemedimpact #atruepartner #weightmanagement #drugtrends #medtalksminute
To view or add a comment, sign in
-
TCET Timing, EU Reforms, Opioid Devices, and More In this week's Pathways Picks: • CMS signals its final Transitional Coverage for Emerging Technologies pathway could be published this month • EU makes official several #IVDR and #MDR reforms • CMS issues its outpatient payment proposed rule, where a device qualifies for a new opioid-alternative payment • FDA addresses opioid disorder treatment devices and misinformation in #guidance docs • More news from Europe, Japan, and China Get your picks here: https://bit.ly/3Lo84aM #medtech
To view or add a comment, sign in
-
The US election will have a wide-ranging impact on healthcare, specifically as it relates to the fair price of drugs. Get the facts from our expert panel and learn what this means for you and your family. Register for our webinar today. #USElection #HealthPolicy
The next US President will play a pivotal role in setting the maximum fair price for drugs. Don’t wait until November 5 to learn what this will mean for therapies and patients. Get the facts. Register for our 2024 US Election webinar today: https://bit.ly/3SyaLLf #USElection #HealthPolicy
To view or add a comment, sign in
-
How can we change the standard of care? How does neurostimulation become an earlier treatment option for chronic pain? It is an ambitious idea to think a DEVICE could replace repeat drug injections to manage chronic pain. For that to be a reality, the device would have to be fast and easy like a drug, "invisible" like a drug, and needs to be cost effective for providers, patients, and insurers. These are all foundational ideas for how we are developing the Injectrode. Featured here are images from our first-in-human study: A) Fluoroscopic AP view showing bilateral Injectrode placement in the lower back. B) Placement site on day 25, demonstrating virtually invisible placement site after healing. This is what we mean when we say “invisible like a drug.” Patient privacy is important. Note: Investigational device | Limited by federal (United States) law to investigational use only #Injectrode #PainManagement #ChronicPain #PNS #Neuromodulation
To view or add a comment, sign in
-
Vizient participated in a recent U.S. News panel on drug shortages and how health care systems and providers might navigate solutions. It's a great discussion on: - Drug shortage history - Drivers of a drug supply shortage - Solutions - How patients and providers can help - Policy changes
5 Takeaways From U.S. News’ ‘Solving the Crisis of Critical Drug Shortages’ Event
To view or add a comment, sign in
-
Vizient participated in a recent U.S. News panel on drug shortages and how health care systems and providers might navigate solutions. It's a great discussion on: - Drug shortage history - Drivers of a drug supply shortage - Solutions - How patients and providers can help - Policy changes
5 Takeaways From U.S. News’ ‘Solving the Crisis of Critical Drug Shortages’ Event
To view or add a comment, sign in
4,088 followers