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PATIENT PRIVACY IN AN ERA OF SOCIAL MEDIA
The European Union Batteries Regulation 2023/1542 started applying in August 2024 and represents a major change for anyone who manufactures, imports, or sells stand-alone batteries, or products containing batteries....more
The Modernization of Cosmetics Regulation Act of 2022 (“MOCRA”) was signed into law alongside other reforms to the Federal Food, Drug, and Cosmetic Act (“FD&C Act”) on December 29, 2022, as part of a broader consolidated...more
On November 17, 2022, the Court of Justice of the European Union (CJEU) found in its latest principal judgment (Novartis v. Abacus, case file C-147/20) that the reboxing of parallel imported medicines in the European Union...more
US and EU Life Sciences Law firms Fieldfisher & Gardner Law recently held a CLE event in Silicon Valley covering Healthcare Compliance, Data Privacy and Regulatory hot topics for MedTech and Pharma companies. Discussion...more
On 10 April 2020, the European Commission, the EMA and the European medicines regulatory network published a notice providing guidance to stakeholders regarding regulatory expectations for medicinal products for human use...more
Newly issued EU Regulation 2019/933 provides supplementary protection certificate exemptions for exporting and stockpiling active pharmaceutical ingredients and medicinal products if certain anti-abuse requirements are met....more