Biosimilar Regulatory solution center

1. EMA Issues Revised Annex 11, New Annex 22, And Associated Documents On Data Governance 8/6/2025

   The EMA issued three new draft documents in July, all related to the advancement of the use of electronic technology in GMP: AI, computerized systems, and documentation. The public comment period ends Oct. 7.

2. Overcoming Gene Therapy Cost Roadblocks On The Path To Patients 7/23/2025

   Viral vector-based gene therapies are expanding beyond rare diseases to treat larger populations. Discover how innovations in manufacturing are making these life-changing treatments more accessible.

3. Viral Gene Therapy: Reducing Costs To Improve Patient Access 7/23/2025

   Gene therapy is revolutionizing medicine with its potential to cure genetic disorders. As approvals rise, so do concerns about accessibility, with million-dollar price tags limiting patient access.

4. 3 Key Considerations In Gene Therapy Manufacturing 7/15/2025

   Viral vector-based gene therapies are redefining medicine. As developers navigate uncharted territory, Sybil Danby of Cytiva highlights three critical areas shaping the journey from discovery to patient access.

5. Preparing For FDA's Expanded Use Of Unannounced Inspections At Foreign Manufacturing Facilities 7/10/2025

   The FDA announced on May 6, 2025, that it intends to expand its use of unannounced inspections at foreign manufacturing facilities. Here are key considerations and actions to take in order to be prepared.

6. Managing Extractables And Leachables In HPAPI Manufacturing 7/10/2025

   These contaminants can compromise the quality, stability, and safety of a drug product, and regulatory bodies mandate assessment to protect patients.

7. Audit Trail Compliance And What To Look For In Mitigation Software 7/9/2025

   In the pharma/biotech and medical device industries, the audit trail is important to have for accountability, data integrity, repeatability to create an event for investigation, and regulatory compliance.

8. Navigating FDA Regulatory Changes: Policy Shifts, Deregulation, Restructuring, And Future Oversight 6/23/2025

   Recent shifts within the U.S. FDA reflect an increasingly complex tension between scientific rigor and accelerating political and economic pressures. Here are the newest developments and emerging focal points.

9. How Is RIM Software Transforming Regulatory Compliance? 6/20/2025

   Regulatory information management (RIM) software tools streamline global regulatory processes on a single cloud-based platform throughout the entire product life cycle.

10. A Look At Elsa, The FDA's New AI Digital Assistant 6/12/2025

    The U.S. FDA recently launched its very own generative AI tool called Elsa. It's designed to assist FDA employees across various functions, from scientific reviewers to investigators.