What the First FDA AI Warning Letter Means for Pharma
The FDA’s first AI warning letter shows Purolea Cosmetics Lab used AI to draft CGMP documents unchecked. Here’s what pharma manufacturers must learn now.
Regulatory & Commercialisation
Navigate the intersection of compliance, market access, and strategic launch planning to bring approved therapies successfully to patients.
FDA Expedited IND Pilot Targets Faster First-In-Human Trials
The FDA’s Expedited IND Pilot introduces rolling review and sponsor-QRI partnerships to accelerate Phase I first-in-human trials while retaining regulatory oversight.
CDRH Rare Disease Impact Initiative Sets New FDA Focus
The CDRH Rare Disease Impact Initiative puts greater focus on rare disease devices, patient engagement, evidence strategy, and closer FDA coordination.
Libre Duo FDA Authorisation Through De Novo Pathway
Abbott’s Libre Duo FDA authorisation creates a new Class II device category, combining glucose and ketone monitoring while setting a regulatory path for future devices.
FDA 10 Guiding Principles of Good AI Practice in Drug Development
Get to know the FDA 10 Guiding Principles of Good AI Practice in Drug Development and what they mean for AI governance, validation, and regulatory risk.
Co-ordinated EU GMP Inspection Guidelines: What You Need to Know
New EU GMP inspection guidelines take effect in September 2026. Here is what you need to know about joint inspections, planning, and reporting.
FDA Clinical Trial Oversight Tightens Globally
FDA clinical trial oversight is intensifying globally as the agency raises expectations for GCP, foreign site inspections, data integrity, and patient protection.
What Sponsors Need to Know About UK Combined Review 2026
UK Combined Review unifies MHRA and ethics review for CTIMPs, reshaping approval timelines, submissions, and sponsor planning under UK trial reform.
MHRA Clarifies Licensing for Microbiome-Based Medicines
The MHRA has set out its position on microbiome-based medicinal products, confirming that a clear UK licensing route already exists for these therapies.
FDA Oncology Trial Guidance Targets Eligibility Barriers
FDA oncology clinical trial guidance targets restrictive eligibility criteria, covering performance status, washout periods, medications, and laboratory values.
FDA Generic Peptides Guidance Sets New Expectations
Revised FDA draft guidance for generic peptide products updates expectations for ANDAs, impurities, structure, immune response, and biological activity.
AI in GMP Manufacturing: Are Regulators Ready for Digital Factories?
Learn how AI in pharmaceutical GMP manufacturing is improving quality, data integrity, predictive maintenance, and regulatory compliance in modern drug production.
