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Author

f.nichetti

42 Articles

Articles by f.nichetti

EMA Stability Guideline Rev.3: Why It Changes the Way We Manage Post-Approval Variations in 2026
September 23, 2026
English
EMA Stability Guideline Rev.3: Why It Changes the Way We Manage Post-Approval Variations in 2026 next-arrow
Responding to TGA GMP Non-Compliance Notifications: What Sponsors Need to Know
September 16, 2026
English
Responding to TGA GMP Non-Compliance Notifications: What Sponsors Need to Know next-arrow
What makes clinical evidence trustworthy?
September 16, 2026
English
What makes clinical evidence trustworthy? next-arrow
Your EU Dossier Is Not GCC-Ready: What Sponsors Need to Know in 2026
September 15, 2026
English
Your EU Dossier Is Not GCC-Ready: What Sponsors Need to Know in 2026 next-arrow
Ancient History vs. Modern Market Strategy: Botanical shift: Ashwagandha
September 11, 2026
English
Ancient History vs. Modern Market Strategy: Botanical shift: Ashwagandha next-arrow
FDA Proposes Mandatory GRAS Notifications for the Food Industry
September 10, 2026
English
FDA Proposes Mandatory GRAS Notifications for the Food Industry next-arrow
Ten Papers, One Commitment: Five Years of Regulatory Science
September 08, 2026
English
Ten Papers, One Commitment: Five Years of Regulatory Science next-arrow
Can Asian-Dominant Evidence Support an EU Marketing Authorisation?
September 02, 2026
English
Can Asian-Dominant Evidence Support an EU Marketing Authorisation? next-arrow
Move for Health Access: 8,950 kilometres for global health preparedness
August 27, 2026
English
Move for Health Access: 8,950 kilometres for global health preparedness next-arrow
Medsafe's Verification Pathway ("Rule of Two"): A New Opportunity for Faster Market Access in New Zealand
August 03, 2026
English
Medsafe's Verification Pathway ("Rule of Two"): A New Opportunity for Faster Market Access in New Zealand next-arrow
Emerging risks in food supplements: which ingredients could be considered for future Article 8 assessments?
July 27, 2026
English
Emerging risks in food supplements: which ingredients could be considered for future Article 8 assessments? next-arrow
Registering Medicines from Europe or Reference Countries in Latin America
July 24, 2026
English
Registering Medicines from Europe or Reference Countries in Latin America next-arrow
Decision-Making Coherence in Market Access: Six Chapters Connecting Evidence, Value and Access
July 22, 2026
English
Decision-Making Coherence in Market Access: Six Chapters Connecting Evidence, Value and Access next-arrow
When One Trial Does the Work of Two: Why Evidentiary Architecture is Critical
July 13, 2026
English
When One Trial Does the Work of Two: Why Evidentiary Architecture is Critical next-arrow
BIO International 2026: Five Industry Themes That Will Shape the Next Chapter of Biotechnology
July 10, 2026
English
BIO International 2026: Five Industry Themes That Will Shape the Next Chapter of Biotechnology next-arrow
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