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Pharmacovigilance Considerations in the Era of Patient Centricity: …

WebOn World Patient Safety Day, Torrey Cope in Washington, D.C., Chen Yang in Beijing, and Olivier Goarnisson in Geneva consider one big pharmacovigilance …

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URL: https://goodlifesci.sidley.com/2021/09/17/pharmacovigilance-considerations-in-the-era-of-patient-centricity-data-collected-by-apps/

HHS-OIG Rejects Calls for New Safe Harbors for Financial Support …

WebEarlier this month, the U.S. Department of Health and Human Services Office of the Inspector General (HHS-OIG) declined to establish new safe harbors that …

Category:  Health Go Health

What Do the FDA’s Expanded ‘Intended Use

WebPrior to their webinar on Thursday, October 7, Coleen Klasmeier and Jaime Jones consider some of the effects of the final rule.. FDA’s final rule to amend its medical …

Category:  Medical Go Health

Home Page GoodLifeSci

WebSidley Healthcare Investment Conference 2024. With deal and investment activity remaining critical for the success of the life sciences and healthcare industry, …

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How to Create a More Enabling Environment for Digital

WebAt our recent Digital Health App’ero, Zina Chatzidimitriadou led a discussion with key industry players Aleksandra Appelfeld of Philips and Megan Coder of the Digital …

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It Is Now More Difficult For International Pharma To

WebChina’s new Measures for the Security Assessment of Outbound Data Transfers (the “Measures”) came into force on September 1, 2022. Pharma companies …

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Five Tips for Bringing a Complex Digital Health Product to Market

WebThese types of complex digital health products require FDA approval, clearance, or authorization through the de novo pathway, as well as a reimbursement …

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7 Key Trends for the Global Life Sciences Industry in 2023

WebSidley’s 2023 Global Life Sciences Trendspotting Report maps out seven key trends in the life sciences industry globally, and identifies some regional trends in the …

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Forthcoming HHS Regulatory Actions and Opportunities Relevant …

WebPharmaceutical manufacturers need to note some key forthcoming regulatory actions and opportunities which the Department of Health and Human …

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Sidley Digital Health East

WebPlease save the date for a digital health-focused roundtable hosted by Sidley and The Digital Therapeutics Alliance on Wednesday, May 10. Across two panels, …

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Seven Things Life Sciences Buyers and Sellers Should Know About …

WebHere are seven things life sciences buyers and sellers should know about CVRs: CVRs have been gaining popularity in recent in years, particularly in the life …

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Boston Life Sciences Roundtable GoodLifeSci

WebPlease join us for Sidley’s first in-person Boston Life Sciences Roundtable program, an afternoon of provocative discussions addressing cutting-edge trends and …

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New Guidance on Appeals Against UK Health Tech Appraisals

WebThe UK’s National Institute for Health and Care Excellence (NICE) has clarified its guidelines on the process of appealing against its guidance for technology …

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Six Surprises In The Leaked European Pharmaceutical Review

WebOn 31 January 2023, the internally circulated version of the European Commission’s far-reaching overhaul of the EU’s pharma legislation was leaked, and published by Politico. …

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FDA Offers New Clinical Trial Guidance for Oncology Accelerated

WebFDA has now announced the availability of draft guidance on “Clinical Trial Considerations to Support Accelerated Approval of Oncology Therapeutics” pointing out …

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Sidley Healthcare Investment Conference 2023

WebWith deal and investment activity remaining critical for the success of the life sciences and healthcare industry, Sidley is bringing together senior pharma, biotech, healthcare, …

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CMS Now Needs to Approve Medicare Ads That Mention Plan …

WebThe U.S. government has expressed concern over misleading marketing by some Medicare Advantage and Part D plans. Now, a much wider range of marketing …

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Four Ways New Legal Proposals Could Boost the Animal

WebFour Ways New Legal Proposals Could Boost the Animal Health Industry in Great Britain. March 17, 2023. Animal Health, Veterinary Medicines. The UK veterinary …

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Why Venture Capital Investors Are Focused on Femtech

WebThe second is the realization that Femtech has massive growth potential as a market. A report this year by non-profit FemTech Focus estimated the size of the …

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