The Regulatory Navigator

 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.


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


Pursuing alternative approaches to animal models in drug development: EMA innovation task force and scientific advice opportunities

Key implications for nonclinical development: FDA guidance on human gene therapy products incorporating human genome editing


Potency assurance for CGT products: an assessment of FDA’s new draft guidance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


New China CDE guidance on platform validation of viral clearance aligns with FDA and EMA

Exploring China’s new pilot regulatory program for rare disease drug development