Regulatory Rapporteur September 2010
Volume 7 Issue 9
In This Issue
- NORTH AMERICA’S REGULATORY LANDSCAPE
- FDA’s electronic submissions gateway
- Primary IND applications
- Due diligence
- Canada update
Please login to download articles. Non-members may download the Focus article.
| Title | Download | Category | Size | File |
|---|---|---|---|---|
| Regulatory Rapporteur September 2010 | Members | Full Issue | 3MB | |
| Articles | ||||
| Getting started with the FDA’s electronic submissions gateway | Public | 525KB | ||
| A closer look at the MHRA - An interview with Prof Kent Woods, Chief Executive of the Medicines and Healthcare products Regulatory Agency (MHRA) | Members | 508KB | ||
| Canada – News update | Members | 505KB | ||
| Delving into product development due diligence | Members | 493KB | ||
| International conference on VICH: Impact and future expectations | Members | 625KB | ||
| Managing primary IND applications with the FDA | Members | 627KB | ||
| Regulatory and scientific considerations for the follow-up of patients treated with gene therapy medicinal products: an EU perspective | Members | 638KB | ||
| Regulatory updates - Across the pond and around the globe | Members | 486KB | ||
| The current status of biosimilar biologics – Part 1: An international perspective | Members | 515KB | ||
| The Medical Devices Exchange | Members | 464KB |
