Final designs for UK Gov-backed facility 'weeks away' says Cell Therapy Catapult CEO
The CEO of Cell Therapy Catapult says technical designs for the new UK biomanufacturing centre will be completed in the next few weeks.
Archives for October 12, 2015
Dispatches from CPhI 2015
Ex-FDA inspector: How to avoid 483 observations during your next facility audit
Want to pass an FDA inspection? Do not answer back, do not volunteer information and do not sign anything, says an ex-auditor and regulatory consultant.
Dispatches from CPhI
INN guidance leaves FDA in catch-22 over awaited interchangeability rules, experts
Eagerly awaited interchangeability guidance will be at odds with the US FDA’s recent guidance on naming biological products using a four-letter suffix according to a panel of biosimilar experts.