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Tag Archives: Regulatory Pathway

What is Happening with the Provisional Approval Pathway?

We’ve come a long way When the independent review of medicines and medical devices regulation was announced in October 2014, the pharmaceutical sector immediately saw the opportunity for an expediated approval pathway for certain prescription medicines. A provisional approval pathway would allow … Continue reading

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Is our product a medicine, a device, a cosmetic, an OTG or a food… and what could it be?

An increasing number of traditionally pharma/device companies are crossing boundaries to offer their patients a product portfolio spanning several product categories. Examples include medical devices that support delivery and tracking of patient medication as well as cosmetic and sunscreen line … Continue reading

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