Vibha Sharma
Senior Writer

Latest From Vibha Sharma
Global Medtech Guidance Tracker: January 2023
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.
EU Regulators May Check Redactions In CTIS Documents To Boost Trial Transparency
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.
EMA Says Yes To BMS’ Sotyktu But Turns Down Ipsen’s Sohonos
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.
Sponsors Split Over Benefits Of EU Clinical Trials Regulation
A survey undertaken last year on the implementation of the EU Clinical Trials Regulation drew some positive feedback from study sponsors but also threw light on well-known concerns with the legislation. Some of the highlighted issues are being addressed on a priority basis.
EMA Takes Steps To Improve Predictability Of Drug Submissions
The European Medicines Agency says it will become more systematic in seeking explanations from companies who delay or withdraw their planned marketing submissions and in chasing “no-shows.”
BMS’ Plaque Psoriasis Drug Deucravacitinib Among Six Hopefuls Awaiting EMA Verdict
A novel TYK2 inhibitor and a drug to treat an ultra-rare genetic disorder are among products up for a marketing authorization opinion this week from the European Medicines Agency’s human medicines committee, the CHMP.