Italy jumps the gun and 'approves' Clinuvel's photoprotective, afamelanotide, while it's still undergoing the regulatory process worldwide.
Italy's National Health System has bucked the European regulatory system and approved the use and reimbursement of Clinuvel's photoprotective drug, afamelanotide, prior to it gaining regulatory approval in Europe or the US.
In vitro diagnostics legislation has passed into law although the industry still has reservations about compliance costs.
In vitro diagnostics legislation has passed into law although the industry still has reservations about compliance costs.
APVMA registers Erimophilone Oil as an active ingredient, end-user product could be available within two years.
APVMA registers Erimophilone Oil as an active ingredient, end-user product could be available within two years.
The long delayed regulation of in vitro diagnostics is on its way, possibly as early as this year. Manufacturers should prepare themselves to face the TGA.
The long delayed regulation of in vitro diagnostics is on its way, possibly as early as this year. Manufacturers should prepare themselves to face the TGA.
