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.

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


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


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Potency assurance for CGT products: an assessment of FDA’s new draft guidance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


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