Marketing of drugs, medical devices, and other FDA-regulated products is uniquely complex. Get clear explanations from FDA Advertising and Promotion Manual on Lexis+. https://bit.ly/4eHhsnr
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𝐂𝐞𝐧𝐭𝐫𝐞 𝐞𝐱𝐩𝐥𝐨𝐫𝐢𝐧𝐠 𝐧𝐞𝐰 𝐩𝐫𝐢𝐜𝐢𝐧𝐠 𝐬𝐭𝐫𝐚𝐭𝐞𝐠𝐢𝐞𝐬 𝐟𝐨𝐫 𝐦𝐞𝐝𝐢𝐜𝐚𝐥 𝐝𝐞𝐯𝐢𝐜𝐞 𝐢𝐧𝐝𝐮𝐬𝐭𝐫𝐲 The Centre is exploring new pricing strategies for the MedTech industry. The government is also looking at specific regulations to streamline the licensing, trading, and exporting processes for manufacturers. Medical device licences are currently categorized under the Drugs and Cosmetics Act, and the industry has advocated for specific regulations, arguing that the criteria for drug licensing are not suitable for medical devices. #pricing #strategies #MedTech #industry #regulations #licensing #streamline #medical #device #drugs #manufacturers
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The #FDA has released its revised draft guidance, "Addressing Misinformation About Medical Devices and Prescription Drugs," which updates the 2014 guidance. This new document outlines how firms can effectively address third-party misinformation about their products #online. The FDA’s stance on tailored responsive communications marks a significant step in combating misinformation in the medical field. Explore the key takeaways and what they mean for your organization. #LifeSciences #MedicalDevices
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Group Company Secretary, Head of Compliance, Acting Chief Financial officer & Group HRM at FNE Group, Director Corporate Affairs at AR Associates Lahore, Executive Member of Hijab Foundation and CFO at Deejhon’s Pharma
Update by Board of Investment - Prime Minister Office Reducing Business Compliance Burden for the Pharma Industry!! Simplification of Registration Process for Low-Risk Medical Devices. #PRMI #RegulatoryReforsms #regulatorycompliance #investinpakistan #pharmaceuticalindustry #promotingdomesticindustry #localmanufacturers #genericdrugs #PakistanPharmaGrowth #HealthcareInnovation #DomesticIndustryRising #RisingDomesticPharma #InnovationInMedicine
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For companies developing new drugs or seeking approval for medical devices, the importance of a well-crafted regulatory strategy cannot be overstated. In our latest blog, we delve into the significance of a regulatory strategy for FDA approval, exploring how it shapes the success and efficiency of the regulatory process. Read more here: https://lnkd.in/gZsnct5b
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Are you up to date on the latest trends in medical device testing and FDA approval? Leverage our expertise in regulatory, testing, and project management to facilitate your medical device development from the initial design concept to market launch. Get started here: https://lnkd.in/eFEqC9WC #medicaldevicedevelopment #medicaldevice #commercialization #regulatory #biotechnology #medtech #FDAapproval #regulatorycompliance
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FDA Raises Alarm on Growing Data Integrity Issues in Medical Device Premarket Submissions The FDA is increasingly concerned about data integrity issues in premarket submissions for medical devices, such as fraudulent or unreliable laboratory testing data. They are urging manufacturers to independently verify all testing results before submission. These integrity lapses not only impede the regulatory approval process but also erode trust in the medical device industry and impact patient safety. The FDA is calling for rigorous data integrity measures, collaboration, and transparency within the industry to address these challenges. The MHRA in the UK is also working to align regulations with international standards. Both regulatory bodies emphasize the importance of data integrity to safeguard the quality and safety of medical devices. For more details please click the link! https://lnkd.in/dbpqHNHu #marketaccess #reimbursement #pricing #hta #heor #healtheconomics #medicaldevices #pharmaceutical
FDA Raises Alarm on Growing Data Integrity Issues in Medical Device Premarket Submissions
https://marketaccesstoday.com
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Navigating the intricate landscape of medical device development and compliance can be daunting. Under EU regulations, medical devices undergo rigorous testing akin to pharmaceuticals. Our Product Pathway Partnership is designed to enhance this journey. Our team collaborates closely with customers, addressing every facet from application optimisation to regulatory compliance. We guide you through biocompatibility testing, fixture design, and even offer coating services as your commercial manufacturing partner. Our strategic approach ensures flexibility and efficiency, helping you navigate regulatory demands seamlessly. Explore our Product Pathway Partnership for a smoother path to market: https://lnkd.in/dp9dsZjp #BioInteractions #MedicalDevices #BiocompatibleCoatings #MedicalDeviceDevelopment #RegulatoryCompliance #MedicalInnovation #MedTech #PPP
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November 2023 Rev. 3 Questions & Answers for applicants, marketing authorisation holders of medicinal products and notified bodies with respect to the implementation of the Medical Devices and In Vitro Diagnostic Medical Devices Regulations ((EU) 2017/745 and (EU) 2017/746) This revision rev.3 concerns an update of question 2.10 regarding MRP/RUP. A further, more comprehensive update of the Q&As is currently ongoing and will be published in the near future. #medicinalproducts #medicaldevices #produktylecznicze #wyrobymedyczne #drugdevice #notifiedbody #nbopinion #article117
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The #FDA has released its revised draft guidance, "Addressing Misinformation About Medical Devices and Prescription Drugs," which updates the 2014 guidance. This new document outlines how firms can effectively address third-party misinformation about their products #online. The FDA’s stance on tailored responsive communications marks a significant step in combating misinformation in the medical field. Explore the key takeaways and what they mean for your organization. 📰 Check it out today: https://lnkd.in/enwmEE5y #LifeSciences #MedicalDevices Authors: Suzanne Levy Friedman, Komal Karnik Nigam, Jodi Scott, Randy Prebula, Wil Henderson
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