The coming months will be crucial for the so-called “Pharma Package”, the largest revision of EU pharmaceutical law since 1965. So-called “trilogue” negotiations are being held between the European Commission (“Commission”), the European Parliament (“Parliament”) and the Council of the
GoodLifeSci
GoodLifeSci, published by Sidley Austin LLP, focuses on legal developments and regulatory issues affecting the life sciences sector. The blog covers topics such as pharmaceutical and biotech company compliance, drug pricing policies in the U.S. and internationally, securities and disclosure regulations impacting life sciences firms, and corporate governance matters relevant to the industry. It also addresses emerging regulatory frameworks like the European Health Data Space Regulation and provides insights on litigation trends, market challenges, and strategic considerations for life sciences companies navigating complex legal and financial environments.
Latest from GoodLifeSci - Page 3
Key Steps Toward Using Artificial Intelligence in Pharmacovigilance – Sidley Insights on the Recent CIOMS Draft Report
The Council for International Organizations of Medical Sciences Working Group XIV (CIOMS) has produced a draft report (the Draft Report) on the use of artificial intelligence (AI) in pharmacovigilance (PV). Torrey Cope, Anna Melin, and Andrew James provide insights on…
FDA Launches “PreCheck” Program to Support U.S. Pharmaceutical Manufacturing: What Industry Stakeholders Should Know
On August 7, 2025, the U.S. Food and Drug Administration (FDA) announced FDA PreCheck, a new two-phase framework aimed at bolstering the domestic pharmaceutical supply chain by streamlining the regulatory process for U.S.-based drug manufacturing facilities. Notably, the announcement also included…
UK proposes to extend transitional chemical registration deadlines under UK REACH
GB based Chemical manufacturers or importers that relied on EU REACH registrations to continue marketing their products in Great Britain following Brexit have until 8 September 2025 to respond to a UK Government consultation on proposed revised transitional registration deadlines…