📣 ATTN HCPs: Do your patients have questions about generic drugs? FDA has patient education materials for you to share on social media or download and print to share in your office: https://lnkd.in/gZ-KSRvi
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Today, the U.S. Food and Drug Administration (FDA) issued a draft guidance: Use of Real-World Evidence to Support Regulatory Decision-Making for Medical Devices. This draft guidance is an update to the current final guidance to propose clarification about how the FDA evaluates real-world data to be used in the FDA’s regulatory decision-making for medical devices. This draft guidance also proposes expanded recommendations to sponsors considering using real-world evidence to support regulatory submissions for medical devices. https://lnkd.in/eFM3Vey8
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The U.S. Food and Drug Administration has published new draft guidance on “Predetermined Change Control Plans for Medical Devices,” which describes the process by which device sponsors may seek FDA approval for modifications in advance by submitting a PCCP document, which would describe the anticipated changes and how they will be tested and implemented. We summarize this proposed policy in more detail here: https://lnkd.in/edNKsV2t #FDA #medicaldevices #PCCP Authors: Kelliann Payne and Suzanne Levy Friedman
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Check out Kelliann Payne and my overview of FDA's recent draft guidance on PCCPs!
The U.S. Food and Drug Administration has published new draft guidance on “Predetermined Change Control Plans for Medical Devices,” which describes the process by which device sponsors may seek FDA approval for modifications in advance by submitting a PCCP document, which would describe the anticipated changes and how they will be tested and implemented. We summarize this proposed policy in more detail here: https://lnkd.in/edNKsV2t #FDA #medicaldevices #PCCP Authors: Kelliann Payne and Suzanne Levy Friedman
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On July 8, 2024, the FDA Issued an Updated Draft Guidance on Addressing Misinformation About Medical Devices and Prescription Drugs. This guidance aims to further the FDA's mission by empowering the public with accurate, up-to-date, and science-based information about medical products. This information is essential for individuals to make informed healthcare decisions and maintain or improve their health. In addition to the FDA's ongoing efforts to address misinformation, other stakeholders can play a key role in ensuring the public has access to reliable information. This revised draft guidance outlines various strategies available to companies to address misinformation and offers recommendations for those who choose to proactively address false or misleading information about their approved medical products found online. Checkout the new guidance: https://lnkd.in/dFZCrdp6 #medicaldevice #fda
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CLOSING DATE FOR COMMENTS: 10TH SEPTEMBER 2024 You still have time to comment on the FDA updated guidance on how to respond to medical misinformation on prescription drugs and medical devices. This is your opportunity to shape the guidance to ensure that it meets the needs of consumers of medical information and avoid the further spread of misinformation. The full document is available here and comments are welcome: https://lnkd.in/d7cGAZSZ #medicalinformation #misinformation #digitalhealth #guidance
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If not already seen, FDA has provided draft guidance (revising the 2014 guidance) on addressing misinformation about approved drugs and medical devices in connection with internet-based communications by 3rd parties. Such misinformation could apply to an individual product/device or class. Within this draft guidance, it speaks to 2 types of communications: Tailored Responsive Communications (company voluntarily identifies and addresses misinformation by a 3rd party, including those by HCPs) and General Medical Product Communications (not necessarily 3rd party correction but to address specific internet misinformation which can be done through typical promotional methods). It focuses on false, inaccurate and/or misleading information. As with other Q&As, FDA describes what it intends to/not to enforce, helpful definitions, what it applies/doesn’t apply to (e.g., 3rd party opinions/experiences unless it includes misinformation) and examples related to both, and what should be included/disclosed within the company’s communications. As with other FDA guidances, pay attention to the notes/footnotes too! #stayinformed #beintheknow
Addressing Misinformation About Medical Devices and Prescription Drugs
fda.gov
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🔔 Coming June 26! If you work on prescription drug promotion, don’t miss this webinar! Learn directly from FDA experts about the different categories and types of promotion, as well as the regulatory requirements for each. The discussion will cover the clear, conspicuous, and neutral (CCN) final rule, the five standards associated with the rule, and the rule’s compliance date. Register ➡ https://lnkd.in/eyPqVMF4
Rx Drug Promotion and the Clear, Conspicuous, and Neutral Final Rule - Promotional Video
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New Blog: Navigating the FDA Submission Process for Medical Device Products: Six Helpful Reminders. #trinitymconsulting #regulatoryaffairs #medicaldevices #globalconsulting Submitting a medical device product to the U.S. Food and Drug Administration
Navigating the FDA Submission Process for Medical Device Products
trinitymconsulting.com
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Learn more about #ContentManagement with the Term of the Week. This week's choice: Premarket Notification 510(k) The Premarket Notification 510(k) is a premarket submission type used in the US that medical device manufacturers must submit to the Food and Drug Administration (FDA). This premarket submission type made to the FDA is meant to demonstrate that the device is safe and effective. Continue reading: https://hubs.ly/Q02gpGhy0 #ModularContent #MedicalDevices #TechnicalDocumentation
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INFARMED published a new regulation about the Advertisement of Medicinal Products Not Subject to Medical Prescription to the general public through the Digital Channels. Read more about this in our latest publication 👉 https://lnkd.in/dQSJeHku
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