Increased use of the ‘immediate implementation’ provision in the agency’s Good Guidance Practices could help reduce stakeholder uncertainty.
Sponsors and stakeholders soon could see more new US Food and Drug Administration guidances that skip the public comment process prior to their finalization in an effort to speed publication of agency thinking.
Many guidances are issued in draft form at first. After a public comment period, the agency reviews the responses and...
Roche’s filing for Elevidys in the EU followed applications in Middle Eastern countries because those markets accept applications based on approval by the US Food and Drugs Administration.
An ongoing proof-of-concept study by the European Medicines Agency testing the use of US-style standards for submitting non-clinical raw data in marketing applications has received positive feedback from both industry and regulatory assessors so far.
The Pink Sheet's list of EU centralized approvals of new active substances has been updated to include two new products, one of which is Tepezza, Amgen's treatment for moderate to severe thyroid eye disease.
