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Remote Regulatory Assessment Oversight Tools Piloted

WEBChris Fanelli explains what the U.S. Food and Drug Administration’s new draft guidance on remote regulatory assessments means for site inspections in the …

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URL: https://goodlifesci.sidley.com/2022/11/10/remote-regulatory-assessment-oversight-tools-piloted-during-the-covid-19-pandemic-are-here-to-stay/

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

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 …

Category:  Health Go Health

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

Category:  Health Go Health

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 …

Category:  Health Go Health

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 …

Category:  Health Go Health

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 …

Category:  Health Go Health

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 …

Category:  Health Go Health

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 …

Category:  Health Go Health

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 …

Category:  Health Go Health

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 …

Category:  Health Go Health

The U.S. Department of Justice may clamp down on life sciences

WEBThe Biden administration is conducting investigations into potential antitrust violations to which the life sciences industry may be particularly vulnerable because …

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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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How to Guard Against Biologics and Medtech Patents Litigation

WEBLife sciences companies are increasingly looking to the courtroom to resolve their disputes which were simmering during the pandemic. Ching-Lee Fukuda explains …

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Biden Administration Moves to Boost the Bioeconomy

WEBBiden Administration Moves to Boost the Bioeconomy. November 16, 2022. FDA, Regulatory. A new Executive Order in the U.S. aims to ease the path to market for …

Category:  Health Go Health

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, …

Category:  Health Go Health

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 …

Category:  Health Go Health

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 …

Category:  Health Go Health

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 …

Category:  Medicine Go Health

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