Botanical Drug Development in the US and Beyond

• August 27, 2025
• Regulatory

FDA Expands Surprise Inspections at Overseas Manufacturing Sites

• August 20, 2025
• CMC | Regulatory

Precision Neuroscience Secures FDA Approval: Layer 7-T Device Redefines Clinical-Ready Brain–Computer Interfaces

• August 13, 2025
• Clinical | Innovation | Regulatory

FDA Inspection Observations & Form 483: Practical Insights for Industry, Clinical & Regulatory Professionals

• August 6, 2025
• Regulation

Smarter, Cleaner, Greener: The Future of Pharmaceutical Manufacturing

• July 23, 2025
• Sustainability

Combination Products at the Neurological Frontier: Aligning Drug and Device Pathways for Innovation and Patient Impact

• June 24, 2025
• Current Trend

Global Clinical Trial Disclosure in the U.S. – What Every Clinical Team Needs to Know

• June 18, 2025
• Regulation

Project Orbis Expands: A New Era for Global Oncology Drug Approvals

• June 12, 2025
• Regulation

Unlocking the FEI Number: Why Every FDA-Regulated Facility Needs One

• June 4, 2025
• Regulation

Fast-Tracking Cures for Rare Diseases: Inside the FDA’s START Pilot Program

• May 28, 2025
• Regulation

Psychedelic Medicine on the Rise: How Regulators Are Shaping Mental Health Treatment

• May 21, 2025
• Regulation

Japan’s Legacy in Orphan Drug Development

• May 14, 2025
• Events | Regulation

From Animal Models to NAMs-driven AI Tools

• April 30, 2025
• Healthcare Policy

FDA’s QIDP Designation: The Game-Changer in Antimicrobial Drug Innovation

• April 23, 2025
• Regulation

RMAT-The Regulatory Catalyst for Accelerating Regenerative Medicine Therapies

• April 16, 2025
• Regulation

What is an INTERACT Meeting

• April 2, 2025
• Regulation

Understanding Protocol Deviations for Clinical Investigations in the US

• March 19, 2025
• Regulation

Trump’s Drug Tariff Shockwave: Disruption and Reshaping of Global Pharmaceutical Supply Chains

• March 12, 2025
• Politics

Navigating the Future: AI in the Drug Product Life Cycle and Regulatory Landscape

• February 26, 2025
• Regulation

FDA Accelerated Programs in Drug Development

• February 13, 2025
• Regulation

PMDA Phase1 Waiver Guidelines for Japanese Participation in Global MRCTs

• February 7, 2025
• Events

Leadership and Policy Shifts in U.S. Healthcare: Potential Impacts on the Biopharma Industry

• January 31, 2025
• Healthcare Policy

US Agent for FDA Regulated Product Applications

• January 23, 2025
• Regulation