The Regulatory Navigator series explores the evolving regulatory landscape with actionable insight from Parexel's experts, sharing their experience to maximize success for clinical development and patient access.
Read our clinical, non-clinical, CMC, regulatory affairs, and APAC updates.
Clinical
CAR-T product development: an assessment of FDA’s final guidance for industry
New guideline for the management of Systemic Lupus Erythematosus (SLE): Considerations for clinical development
Non-clinical
Pursuing alternative approaches to animal models in drug development: EMA innovation task force and scientific advice opportunities
CMC
Potency assurance for CGT products: an assessment of FDA’s new draft guidance
Hello again! ICH Q5A revision 2 updates guidance for developers of biotechnological products and ATMPs
CMC flexibilities in biological medicinal product development: The current EU perspective
Regulatory Affairs
BIOSECURE Act: Implications for US-based drug developers
Real-world evidence methods for regulatory decision making: An HMA/EMA update
The clock is ticking on EU-CTR transitions: To meet the deadline, act now
Regulatory acceptability of AI: Current perspectives
CAR-T boxed warnings: regulatory precedents and opportunities
The EU-CTR transition: Four key ways to prepare now
APAC
New China CDE guidance on platform validation of viral clearance aligns with FDA and EMA