The European Medicines Agency
has released a new draft scientific
guideline outlining how “postauthorisation
efficacy studies”
should be designed by companies
to support regulatory decision
making in the European Union.
The studies are conducted within
the authorised indication after
a medicine has been granted a
marketing authorisation, to collect
data on aspects of its benefits that
can only be explored once the
medicine is marketed.
See www.ema.europa.eu.The above article was sent to subscribers in Pharmacy Daily's issue from 10 Nov 15 To see the full newsletter, see the embedded issue below or CLICK HERE to download Pharmacy Daily from 10 Nov 15
RESPONDING to the findings from the Royal Commission into Aged Care Quality and Safety, a recent government initiative aims to improve medication management in residential aged care facilities by introducing on-site pharmacists.
RESEARCHERS at Charles Darwin University (CDU) are advancing a novel drug delivery system that could potentially eliminate the need for injections to treat various chronic diseases.
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