NME approvals on the rise?

NME approvals on the rise?

The US Food and Drug Administration (FDA) approved 15 New Molecular
Entities in the current year to 30 September, 2003, setting the
stage to outpace last year's registrations by nearly 20 per cent,
says a report from Cutting...

GMP on the agenda

GMP on the agenda

Mixed news on GMP compliance, as Australia's API has its
manufacturing license renewed after a six-week suspension and GSK
unveils a US FDA probe.


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