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US Food and Drug Administration has proactively added Janssen Pharmaceuticals’ combination therapy of teclistamab ...
The International Council for Harmonisation (ICH) is signaling a significant shift in how global regulatory ...
Regulatory requirements continue to evolve independently across regions, particularly for advanced therapies, ...
Global Capability Centers (GCCs) are becoming essential for life-sciences organizations navigating increasingly ...
A newly proposed draft guidance on the development of regenerative medicine therapies has prompted significant ...
The approval pathway for CAR T-cell therapies is entering a new phase as regulators signal a shift toward more ...
At the 2025 Food and Drug Law Institute (FDLI) Enforcement, Litigation, and Compliance Conference, senior ...
In 2026, regulators across major markets are signaling a shift toward risk-based supplier management—and companies ...
Industry groups are calling for the withdrawal of multiple draft guidances related to 510(k) submissions and the ...
The US Food and Drug Administration has issued its final guidance outlining expectations for promotional labeling ...
European lawmakers have reached a provisional agreement on the most comprehensive overhaul of the European Union’s ...
A newly proposed draft guidance on the development of regenerative medicine therapies has prompted significant ...
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