Regulatory updates July 2006
Europe
- EMEA positive to transgenics.
- Alpha interferon bio-similar concept paper.
- Environmental risks.
- Faster scientific advice.
USA
- FDA approval on follow-on somatotropin.
- Withdrawal of CMC documents.
- FDA on Canadian BSE risks.
Slide Presentations
- PDA on IND and BLA processes.
- FDA on follow-on proteins
- WHO meeting. FDA tissue regulations.
For more information please download the document on Regulatory updates web page
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