Welcome to the Goodwin’s Life Sciences Perspectives Blog, a resource specifically aimed at addressing your most frequent and pressing issues and providing insights on current developments.

The challenges across the life sciences industry are as abundant as the opportunities. From tightening federal regulations and market forces to revolutionary innovations, the headwinds are stiff and shifting but they are navigable. We will be tracking emerging issues and developments on private and public company matters, licensing deals and collaborations, patent and IP matters, FDA and healthcare regulatory compliance, and European and Asian developments for life sciences companies. Sign up to receive postings from Goodwin’s Life Sciences Perspectives blog by clicking here.

 

Modernizing the FDA’s 510(k) Program for Medical Devices: Selection of Predicate Devices and Use of Clinical Data in 510(k) Submissions

On September 6, 2023, the US Food and Drug Administration (FDA) released a trio of draft guidances in its efforts to “strengthen and modernize” the 510(k) Program and provide for more “predictability, consistency, and transparency” for the 510(k) premarket review process. In this post, we discuss the two new draft…

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UK’s Medicines Regulator Announces Guidance on the New International Recognition Procedure for the Approval of New Medicines from 1 January 2024

Background Earlier this year, the UK’s medicines regulator, the Medicines and Healthcare products Regulatory Agency (MHRA), announced that a new International Recognition Procedure (IRP) will be put in place for the approval of new medicines from 1 January 2024. On 4 September 2023, the MHRA announced the publication of detailed…

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PropSci Perspectives: Breakthrough Properties

The Goodwin Propsci team has partnered with several well-known companies for a short video series that explores what’s happening in the real estate life sciences industry. In our latest installment, Susie Harborth, Chief Business Officer at Breakthrough Properties, joins Nicole Riley for a thought-provoking discussion. Breakthrough Properties is a life sciences real estate development…

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LDT Proposed Rule Remains Under OIRA Review

Throughout August 2023, the Office of Information and Regulatory Affairs, Office of Management and Budget, Executive Office of the President (“OIRA”) has held stakeholder meetings regarding a proposed rule which, if enacted, would amend the U.S. Food and Drug Administration’s  (“FDA’s”) regulations to make explicit that laboratory developed tests (“LDTs”)…

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Spotlight on Life Sciences Collaboration and License Agreements

Goodwin’s Intellectual Property team regularly works on the most important deals in the life sciences and biotech sector. Our close relationship with clients ensures that the best intellectual property strategies are in place to foster company and product growth and minimize risk. We take pride in structuring, negotiating, and executing…

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Common FDA Bioresearch Monitoring Violations: Updates from FY 2022 to Now

The Bioresearch Monitoring (BIMO) Program, operated by the U.S. Food and Drug Administration (FDA), conducts on-site inspections and data audits in order to effectively monitor the compliance of all FDA-regulated research. As a follow up to our June 2022 post, we highlight the most common violations identified in Fiscal Year…

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A Look Ahead in Life Sciences: What We Are Tracking in Q3 2023 and Beyond

As the life sciences industry continues to expand and grow increasingly complex, so does its legal, regulatory, and compliance landscape. To help companies and investors navigate the many evolving and emerging laws and regulations across pharmaceuticals, biologics, medical devices, diagnostics, and laboratory testing, our Life Sciences Regulatory & Compliance team…

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The European Commission Proposes First Major Overhaul of the EU Medicines Regulatory Framework in 20 Years: Orphan Medicines

We recently published an alert in relation to the European Commission’s legislative proposals to replace the current EU regulatory framework for all medicines (including those for rare diseases and for children). One of the major elements of the proposals is a change to the legislation governing orphan medicines for rare diseases,…

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