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Compliance Tip of the Day: COSO Objective 3 – Control Activities
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Healthcare Enterprise Risk Management
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State AGs Unite: New Privacy Task Force Signals Shift in Regulatory Power Dynamics — Regulatory Oversight Podcast
The fatal flaws in the 2023 CRA rule
Evolving AI Legislation: Federal Policies, Task Forces, and Proposed Laws — The Good Bot Podcast
State AGs Unite: New Privacy Task Force Signals Shift in Regulatory Power Dynamics — The Consumer Finance Podcast
From Cell Phones to Tractors: The Right to Repair Movement Drives On — Regulatory Oversight Podcast
AI Legislation: The Statewide Spotlight - Regulatory Oversight Podcast
The boundary between medicinal products and medical devices remains a recurring issue for companies developing or marketing borderline products and courts, which has already been the subject of numerous decisions. Recently,...more
As the life sciences, medtech, and diagnostic industries continue to expand and grow increasingly complex, so does the legal, regulatory, and compliance landscape. To help companies and investors navigate the many evolving...more
The European Commission has published its long awaited and leaked proposals for a once-in-a-generation revision of the EU general pharmaceutical legislation (GPL)....more
On 23 March 2023 the new Spanish Medical Devices Regulation (Spanish MDR) came into force. After a lengthy wait, the medical devices industry (and any other interested sector) finally has access to the final text and knows...more
STADA and Xbrane Announce Approval of Ranibizumab Biosimilar in UK - On January 16, 2023, STADA Arzneimittel AG (STADA) and Xbrane Biopharyma AB (Xbrane) announced that the UK’s Medicines and Healthcare product Regulatory...more
In August 2022, the European Commission published a revision to Annex 1 “Manufacture of Sterile Medicinal Products” in EudraLex - Volume 4 - Good Manufacturing Practice (GMP) guidelines that will significantly impact...more
In recent years we have seen more and more gene and cell therapies coming successfully to market – but many more such candidates have not made it to market, or been unable to obtain sufficient reimbursement. Gene and cell...more
Amy Dow and Brad Thompson, Members of the Firm, speak on “Shaping the Future of Artificial Intelligence (AI) Within Life Sciences,” a virtual program co-hosted by Simmons & Simmons and Epstein Becker Green. On both sides of...more
The Spanish Ministry of Health has initiated the hearing and public information process for the new regulation on medical devices. The draft text will be available for contributions by 10 July 2021. The direct application of...more
On 25 November 2020, the European Commission published a proposal for a new Pharmaceutical Strategy for Europe (“the Strategy”). The Strategy is built around four main objectives, each with an assigned work strand....more
On 17 November 2020, the European Commission published an inception impact assessment for a revision of the Tissue Directive and the Blood Directive. With this proposal, the European Commission aims to tackle existing...more
On 10 June 2020, the MDCG issued guidance MDCG 2020-12 on the transitional provisions concerning the consultation of authorities regarding devices incorporating a substance.....more
The European Commission today announced that it is preparing a proposal to postpone the entry into application of the new Medical Devices Regulation (MDR). The proposed postponement would be for one year....more
The Daily Report is a compilation of COVID-19 (coronavirus) news briefs from around the world to help life sciences and health care companies stay current in this challenging time. ...more
Spain’s Ministry of Health initiated proceedings for approval of the new regulation on medical devices with a call for a prior public consultation to receive contributions from interested parties....more
The White House will again slap tariffs on steel and aluminum imports from Argentina and Brazil in an apparent reaction to “massive devaluation” of currencies in both South American nations....more
On 26 September 2019, the European Commission published a new Guidance of the Medical Device Coordination Group (MDCG) concerning the Summary of Safety and Clinical Performance (SSCP). This document is aimed at manufacturers...more
The Paris office of Hogan Lovells is pleased to provide this English language edition of our monthly e - newsletter, which offers a legal and regulatory update covering France and Europe for April 2018. ...more
In the process of getting ready for the implementation of the forthcoming medical devices Regulations the European Commission published on 10 September 2019 the Commission Implementing Decision (EU) 2019/1396 (Decision)...more
On 23 July 2019, the European Commission published the draft Commission Implementing Regulation (hereafter “Draft”) regarding Common Specifications for the reprocessing of single-use medical devices....more
The MDR and other recent developments in the health care regulatory landscape pose new opportunities and challenges for medical software companies and investors in digital health in the United Kingdom. Although the regulatory...more
A decade ago, the European Commission conducted a thorough sectoral inquiry into the European pharmaceutical sector that identified antitrust shortcomings impeding access to more affordable and innovative medicines and...more
Do you hold a CE certificate of conformity issued by a UK notified body? Are your manufacturing activities, authorised representative, suppliers, customers or contracting parties located in the UK? ...more
On 1 February 2019, the European Commission published a new Q&A document to give further guidance on the Notice to stakeholders-withdrawal of the United Kingdom and EU rules in the field of industrial products (“the Notice”)....more