On January 6, 2025, the FDA released draft guidance on using artificial intelligence (AI) in regulatory decision-making for drugs and biological products. The draft guidance – the first of its kind from the agency – aims to...more
2/13/2025
/ Artificial Intelligence ,
Compliance ,
Corporate Counsel ,
Data Integrity ,
Digital Health ,
Food and Drug Administration (FDA) ,
Life Sciences ,
Pharmaceutical Industry ,
Regulatory Oversight ,
Regulatory Requirements ,
Risk Management
As a firm responsible for managing global portfolios for pharmaceutical companies, we closely follow and seek to stay abreast of developments regarding patentability in various jurisdictions. We recently reviewed the Unified...more
8/22/2024
/ Amgen v Sanofi ,
Corporate Counsel ,
Disclosure ,
Enablement Inquiries ,
Inventions ,
Patent Invalidity ,
Pharmaceutical Patents ,
Prior Art ,
Priority Patent Claims ,
Sanofi-Aventis ,
SCOTUS ,
Unified Patent Court