Topics Date Clear Filters Registration & Listing of Cosmetic Facilities and Products in the US September 17, 2025 CMC | Regulatory Navigating FDA Regulations for Nanomedicines and Devices September 10, 2025 Regulatory Fast Track vs. Breakthrough Therapy: Key Clinical Strategy Differences September 3, 2025 Clinical | Regulatory 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 Regulatory Psychedelic Medicine on the Rise: How Regulators Are Shaping Mental Health Treatment May 21, 2025 Regulatory Japan’s Legacy in Orphan Drug Development May 14, 2025 Regulatory From Animal Models to NAMs-driven AI Tools April 30, 2025 Innovation | Nonclinical FDA’s QIDP Designation: The Game-Changer in Antimicrobial Drug Innovation April 23, 2025 Regulatory RMAT-The Regulatory Catalyst for Accelerating Regenerative Medicine Therapies April 16, 2025 Regulatory What is an INTERACT Meeting April 2, 2025 Regulation Understanding Protocol Deviations for Clinical Investigations in the US March 19, 2025 Clinical 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 Innovation | Regulation FDA Accelerated Programs in Drug Development February 13, 2025 Regulatory 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 Politics US Agent for FDA Regulated Product Applications January 23, 2025 Regulatory
Registration & Listing of Cosmetic Facilities and Products in the US September 17, 2025 CMC | Regulatory
Fast Track vs. Breakthrough Therapy: Key Clinical Strategy Differences September 3, 2025 Clinical | 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
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
Psychedelic Medicine on the Rise: How Regulators Are Shaping Mental Health Treatment May 21, 2025 Regulatory
RMAT-The Regulatory Catalyst for Accelerating Regenerative Medicine Therapies April 16, 2025 Regulatory
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 Innovation | Regulation
Leadership and Policy Shifts in U.S. Healthcare: Potential Impacts on the Biopharma Industry January 31, 2025 Politics
