Global Pharma Guidance Tracker – October 2022
Stay up to date on regulatory guidelines from around the world with the Pink Sheet's Guidance Tracker. The complete Global Pharma Guidance Tracker, with sortable and searchable listings going back to 2014, is available online.
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Stay current on regulatory guidelines from around the world with Medtech Insight's Guidance Tracker. Forty-eight documents have been posted on the tracker since its last update.
A new EU guideline addresses numerous questions raised by study sponsors on processes for protecting commercial and personal data while using the Clinical Trials Information System.
The European Medicines Agency has recommended pan-EU marketing approval for four medicines but turned down Ipsen’s treatment for an ultra-rare bone disorder. It has also OK’d new uses of seven already-approved drugs and is reviewing efficacy concerns regarding Novartis’ sickle cell medicine.