America’s early-stage clinical trials have increasingly moved overseas, raising concerns about the nation’s long-term competitiveness in biomedical innovation.
Pharma
The update aims to clarify how manufacturers should approach similarity assessments, indication extrapolation, and post-market safety monitoring.
Just in time for midterm elections, a new RFI seeks public input on Medicare drug pricing negotiations, inflation-based rebates, and supply-chain oversight.
The drug maker says data about individual transactions, including patient, provider, service, and payment details, is needed to meet obligations under the Inflation Reduction Act.
A demand to turn over a clinical-level data mandate in less than a week has roiled the sector, raising alarms about access to 340B discounts and the future of the safety net program.
GRIP will partner with Informa Connect’s Pharmaceutical Compliance Congress: Canada to capture how compliance leaders are helping the industry innovate responsibly amid regulatory complexity.
Key takeaways from the draft 2026 Merger Guidelines and practical advice.
The partnership will introduce Anthropic’s Claude’s agentic AI capabilities into research, clinical development, manufacturing, commercial operations, and corporate functions.