FDA on Tuesday finalized guidance for sponsors explaining how it assesses user fees for combination products and the different programs available to sponsors for requesting user fee waivers under the Prescription Drug User Fee Act and the Medical Device User Fee Amendments programs. Joanne Eglovitch reports in Regulatory Focus ✍️ 📣 https://bit.ly/3LxhfFW
Regulatory Affairs Professionals Society (RAPS)’s Post
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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 ➡
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As a result of the changes to Medicare Part D under §11201 of the Inflation Reduction Act of 2022, on April 1, 2024, CMS released Final Redesign Program Instructions (“Final Program Instructions”) for the Medicare Part D prescription drug program which are effective starting in 2025. To learn more: https://bit.ly/3Xa3hB0
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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
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You CAN use GoodRx while on Medicare. We’ll show you how, as well as several other ways to get prescription drug pricing. https://lnkd.in/g9fYiHFt #medicaremindset #medicare #goodrx
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Why You Need to Understand Medicare Part D Prescription Tiers Understanding Medicare Part D prescription drug formulary tiers is crucial for managing your prescription drug coverage. Learn more about how these tiers work and how they can affect your out-of-pocket costs. If you're looking for information on prescription drugs and Medicare coverage, this video is a must-watch! #MedicarePartD #Medicare
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A new law in Colorado aims to make prescription labels more accessible to visually impaired people. The act requires a pharmacy, on and after July 1, 2025, to provide an individual who has difficulty seeing or reading standard printed labels on prescription drug containers with access to the prescription drug label information by: ・Including an electronic label affixed to the prescription drug container that transmits the prescription drug's label information, directions, and written instructions to an individual's external accessible device, including an individual's compatible prescription drug reader; ・Providing a prescription drug reader at no cost to the individual; ・Providing a prescription drug label in braille or large print; or ・Providing the individual with a method recommended by the United States access board. #accessiblecode #socialinclusion #packaging #accessibility #sustainability https://lnkd.in/d2B--aKF
Prescription Drug Label Accessibility
leg.colorado.gov
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The latest Medicare Musings episode is out now! This month, we're all about Medicare Advantage & Prescription Drug plans. Need a quick refresher or deeper insights? Tune in today for everything you need to know! #MedicareMusings #MedicareAdvantage Watch now at https://lnkd.in/gS9SQKTt
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Expert in Developing Products, Businesses, and People in Life Sciences | Biotech, Medtech, & Health Tech | Women in STEM and Inclusive Leadership Champion
In the Covid era, we’ve primarily been limited to remote meetings with a FDA. In 2024 FDA has said that face-to-face meetings will become more common and can again be requested by drug developers. However, remote and hybrid meetings, have some real benefits to sponsors, allowing easier attendance for remote and global employees, and making notetaking more intuitive. For both FTA and sponsors, hybrid, and remote meetings may allow for a array of times, making it easier to find meeting times. On the other side of the coin, face-to-face meetings, allow for a personal connections, and sometimes can yield insights into review team thinking on a deeper level. How will you schedule your meetings for 2024? #fda #biotechnology #drugdevelopment #regulatoryaffairs #leadership
Beginning January 22, 2024, FDA's CDER and CBER will expand in-person face-to-face industry meetings (with a hybrid component), to include all Prescription Drug User Fee Act (PDUFA), Biosimilar User Fee Act (BsUFA), and Over-The-Counter Monograph Drug User Fee Program (OMUFA) meeting types. To learn more, visit: https://lnkd.in/gRWp44kA
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Deputy Director, Office of Minority Health, Centers for Medicare & Medicaid Services
Understanding prescriptions and feeling confident in navigating drug coverage can be difficult for many. Download our newest Coverage to Care resource, “Tips for Understanding Your Drug Coverage & Prescriptions,” to help your patients feel confident in properly managing their drug coverage, including prescription costs and labels, drug restrictions, and more. Read more here 👉 https://lnkd.in/eUayzcNz #Coverage2Care #DrugCoverage #MedicationManagement
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IMC helps bring drugs to market sooner. Med-ic® is the only Smart blister ever submitted with a FDA priority review resulting in a blockbuster drug approval (Orlissa). med-ic.com
Unlock the power of Information Mediary Corp’s CertiScan solution in revolutionizing FDA drug approvals. 💊 By providing crucial insights into patient medication adherence, CertiScan ensures the fast-track approval of life-saving medications, saving billions in resources. Say goodbye to uncertainty and elevate your research from thin ice to solid ground! #MedicationAdherence #FDAApproval #Innovation #clinicaltrials #certiscan
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