Yesterday, March 13, 2024, the European Parliament approved the EU Artificial Intelligence Act (“AI Act”), a sweeping AI governance framework which presents the first comprehensive law in the world aimed at ensuring AI...more
3/15/2024
/ Artificial Intelligence ,
Compliance ,
Compliance Dates ,
Digital Services ,
EU ,
European Commission ,
European Parliament ,
Exceptions ,
General Data Protection Regulation (GDPR) ,
Machine Learning ,
Member State ,
Multinationals ,
Penalties ,
Regulatory Authority ,
Risk-Based Approaches ,
Technology
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
1/4/2024
/ Advertising ,
Biosimilars ,
Center for Biologics Evaluation and Research (CBER) ,
Clinical Trials ,
Compliance ,
Draft Guidance ,
EU ,
European Commission ,
European Medicines Agency (EMA) ,
Federal Food Drug and Cosmetic Act (FFDCA) ,
Food and Drug Administration (FDA) ,
Inflation Reduction Act (IRA) ,
Life Sciences ,
Manufacturers ,
Marketing ,
Medical Devices ,
Medicare ,
Medicines and Healthcare Products Regulatory Agency (MHRA) ,
Pharmaceutical Industry ,
Popular ,
Prescription Drugs ,
Proposed Legislation ,
Regulatory Standards ,
Research and Development ,
UK
On 25 March 2022, President Biden and the President of the European Commission (“EC”) von der Leyen announced that the U.S. and EU reached an agreement in principle on a new Trans-Atlantic Data Privacy framework for...more
3/30/2022
/ Court of Justice of the European Union (CJEU) ,
Data Protection ,
EU ,
EU-US Privacy Shield ,
European Commission ,
European Court of Justice (ECJ) ,
European Data Protection Board (EDPB) ,
International Data Transfers ,
Personal Data ,
Schrems I & Schrems II ,
Standard Contractual Clauses