THE European Medicines Agency
has announced a six month public
consultation on a revised guideline
covering the “non-clinical and
clinical development of similar
biological medicinal products
containing low-molecular-weight
heparins (LMWHs)”.
The guideline describes a range of
requirements for biosimilar
LMWH’s such as efficacy and safety
studies, and has been updated to
reflect the possibility that a “riskbased”
approach can be followed,
with in vivo studies not required.The above article was sent to subscribers in Pharmacy Daily's issue from 01 Feb 13 To see the full newsletter, see the embedded issue below or CLICK HERE to download Pharmacy Daily from 01 Feb 13
IN WESTERN Australia, Michael’s Chemist Group has started stocking therapeutic Nicotine Vaping Products (NVPs), pursuant to the Federal Government’s new vaping laws (PD 25 Mar).
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