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.
Latest blogs
Blog
Accelerate UK market entry: Leverage the MHRA's new International Recognition Procedure
Aug 11, 2025
Blog
RNA-based therapies: Aligning CMC strategies with “borrowed” FDA regulatory guidance
Jun 30, 2025
Blog
FDA’s new priority voucher review program: Potential implications and next steps for sponsors
Jun 20, 2025
Blog
Manufacturing and control strategies for Cell and Gene Therapy products: Navigating EU and US regulatory requirements
Jun 12, 2025
Blog
Optimize your CMC strategy: Five steps to avoid regulatory setbacks
May 15, 2025
Blog
FDA guidances for development of oligonucleotide therapeutics: Key takeaways for sponsors
May 5, 2025
Latest blogs
Blog
Accelerate UK market entry: Leverage the MHRA's new International Recognition Procedure
Aug 11, 2025
Blog
RNA-based therapies: Aligning CMC strategies with “borrowed” FDA regulatory guidance
Jun 30, 2025
Blog
FDA’s new priority voucher review program: Potential implications and next steps for sponsors
Jun 20, 2025
Blog
Manufacturing and control strategies for Cell and Gene Therapy products: Navigating EU and US regulatory requirements
Jun 12, 2025
Blog
Optimize your CMC strategy: Five steps to avoid regulatory setbacks
May 15, 2025
Blog
FDA guidances for development of oligonucleotide therapeutics: Key takeaways for sponsors
May 5, 2025
Clinical
Blog
Streamlining orally inhaled product (OIP) development with EMA’s new guideline – the clinical perspective
Mar 17, 2025
Blog
Updated European Society of Cardiology guidelines: opportunities and risks for clinical trials
Jan 21, 2025
Blog
How can ECAs be used to accelerate the development of better medicines?
Nov 25, 2024
Blog
FDA’s final guidance on renal impairment: Assessment of the regulatory approach to inform clinical development planning
Oct 23, 2024
Blog
Single-arm trials as pivotal evidence: Key considerations and implications for drug developers
Oct 11, 2024
Blog
PD-1 inhibitors face scrutiny in esophageal cancer: Key takeaways for drug developers
Oct 4, 2024
Blog
FDA releases draft guidance on oncology multiregional clinical trials (MRCTs): Key considerations for global drug development
Sep 20, 2024
Blog
CAR-T product development: an assessment of FDA’s final guidance for industry
Feb 27, 2024
Blog
New guideline for the management of Systemic Lupus Erythematosus (SLE): Considerations for clinical development
Jan 12, 2024
Blog
New FDA draft guidance: Implications for simplifying interchangeability for biosimilars in the US
Jul 16, 2024
Clinical
Blog
Streamlining orally inhaled product (OIP) development with EMA’s new guideline – the clinical perspective
Mar 17, 2025
Blog
Updated European Society of Cardiology guidelines: opportunities and risks for clinical trials
Jan 21, 2025
Blog
How can ECAs be used to accelerate the development of better medicines?
Nov 25, 2024
Blog
FDA’s final guidance on renal impairment: Assessment of the regulatory approach to inform clinical development planning
Oct 23, 2024
Blog
Single-arm trials as pivotal evidence: Key considerations and implications for drug developers
Oct 11, 2024
Blog
PD-1 inhibitors face scrutiny in esophageal cancer: Key takeaways for drug developers
Oct 4, 2024
Blog
FDA releases draft guidance on oncology multiregional clinical trials (MRCTs): Key considerations for global drug development
Sep 20, 2024
Blog
CAR-T product development: an assessment of FDA’s final guidance for industry
Feb 27, 2024
Blog
New guideline for the management of Systemic Lupus Erythematosus (SLE): Considerations for clinical development
Jan 12, 2024
Blog
New FDA draft guidance: Implications for simplifying interchangeability for biosimilars in the US
Jul 16, 2024
Non-clinical
Blog
FDA guidances for development of oligonucleotide therapeutics: Key takeaways for sponsors
May 5, 2025
Blog
Advancing the transition from animal models to alternative methods: FDA's initiative and sponsors' opportunities
May 1, 2025
Blog
The future of drug development: Leveraging EMA support for use of alternative nonclinical approaches
Jun 6, 2024
Blog
Key implications for nonclinical development: FDA guidance on human gene therapy products incorporating human genome editing
Jul 1, 2024
CMC
Blog
RNA-based therapies: Aligning CMC strategies with “borrowed” FDA regulatory guidance
Jun 30, 2025
Blog
Manufacturing and control strategies for Cell and Gene Therapy products: Navigating EU and US regulatory requirements
Jun 12, 2025
Blog
Optimize your CMC strategy: Five steps to avoid regulatory setbacks
May 15, 2025
Blog
Biosimilar reference medicinal product (RMP) regulatory requirements: China, US and EU comparison
Dec 20, 2024
Blog
Oral phenylephrine removal from OTC nasal decongestants: next steps for sponsors
Dec 13, 2024
Blog
Gene therapy: are high costs and manufacturing complexities impeding progress?
Jul 31, 2024
Blog
Potency assurance for CGT products: an assessment of FDA’s new draft guidance
Mar 21, 2024
Blog
Hello again! ICH Q5A revision 2 updates guidance for developers of biotechnological products and ATMPs
Mar 21, 2024
Blog
CMC flexibilities in biological medicinal product development: The current EU perspective
Jan 12, 2024
CMC
Blog
RNA-based therapies: Aligning CMC strategies with “borrowed” FDA regulatory guidance
Jun 30, 2025
Blog
Manufacturing and control strategies for Cell and Gene Therapy products: Navigating EU and US regulatory requirements
Jun 12, 2025
Blog
Optimize your CMC strategy: Five steps to avoid regulatory setbacks
May 15, 2025
Blog
Biosimilar reference medicinal product (RMP) regulatory requirements: China, US and EU comparison
Dec 20, 2024
Blog
Oral phenylephrine removal from OTC nasal decongestants: next steps for sponsors
Dec 13, 2024
Blog
Gene therapy: are high costs and manufacturing complexities impeding progress?
Jul 31, 2024
Blog
Potency assurance for CGT products: an assessment of FDA’s new draft guidance
Mar 21, 2024
Blog
Hello again! ICH Q5A revision 2 updates guidance for developers of biotechnological products and ATMPs
Mar 21, 2024
Blog
CMC flexibilities in biological medicinal product development: The current EU perspective
Jan 12, 2024
Regulatory Affairs
Blog
Accelerate UK market entry: Leverage the MHRA's new International Recognition Procedure
Aug 11, 2025
Blog
FDA’s new priority voucher review program: Potential implications and next steps for sponsors
Jun 20, 2025
Webinar
Challenges and best practices for developing Antibody-Drug Conjugates (ADCs)
Nov 12, 2024
Blog
Accelerated approval: Navigating FDA’s recent guidance and confirmatory trial considerations
Mar 6, 2025
Blog
Navigating the path to conditional approval: avoiding pitfalls in oncology drug applications
Feb 4, 2025
Blog
How to maintain EU-CTR compliance for studies after slim transition
Dec 10, 2024
Blog
BIOSECURE Act: Implications for US-based drug developers
Apr 10, 2024
Blog
Real-world evidence methods for regulatory decision making: An HMA/EMA update
Jun 21, 2024
Blog
The clock is ticking on EU-CTR transitions: To meet the deadline, act now
May 20, 2024
Blog
Regulatory acceptability of AI: Current perspectives
Mar 7, 2024
Blog
CAR-T boxed warnings: regulatory precedents and opportunities
Feb 9, 2024
Blog
The EU-CTR transition: Four key ways to prepare now
Jan 12, 2024
Regulatory Affairs
Blog
Accelerate UK market entry: Leverage the MHRA's new International Recognition Procedure
Aug 11, 2025
Blog
FDA’s new priority voucher review program: Potential implications and next steps for sponsors
Jun 20, 2025
Webinar
Challenges and best practices for developing Antibody-Drug Conjugates (ADCs)
Nov 12, 2024
Blog
Accelerated approval: Navigating FDA’s recent guidance and confirmatory trial considerations
Mar 6, 2025
Blog
Navigating the path to conditional approval: avoiding pitfalls in oncology drug applications
Feb 4, 2025
Blog
How to maintain EU-CTR compliance for studies after slim transition
Dec 10, 2024
Blog
BIOSECURE Act: Implications for US-based drug developers
Apr 10, 2024
Blog
Real-world evidence methods for regulatory decision making: An HMA/EMA update
Jun 21, 2024
Blog
The clock is ticking on EU-CTR transitions: To meet the deadline, act now
May 20, 2024
Blog
Regulatory acceptability of AI: Current perspectives
Mar 7, 2024
Blog
CAR-T boxed warnings: regulatory precedents and opportunities
Feb 9, 2024
Blog
The EU-CTR transition: Four key ways to prepare now
Jan 12, 2024
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