US ‘Lags Behind’ EU & Canada On Clinical Data Transparency
Health Canada Found To Offer The Most Efficient Source Of Regulatory Data
The US Food and Drug Administration has proactively released data for just one drug, compared with data released for over 100 drugs by the European Medicines Agency and just over 70 drugs by Health Canada, according to a study that compared the accessibility and comprehensiveness of the data that the three regulators proactively or reactively disclose.
You may also be interested in...
Discussions are ongoing at Health Canada on the feasibility of adopting the UK model of easing clinical study requirements for biosimilars, said director general Celia Lourenco at a recent event. Meanwhile, the US FDA’s stance is unchanged for now.
Eli Lilly has asked the European Medicines Agency to grant accelerated assessment to its planned EU marketing application for pirtobrutinib. Meanwhile, the agency has rejected requests to fast-track SIFI’s Akantior and Janssen’s Zejula plus Zytiga combination therapy.
Health technology assessment body NICE has now rejected Spravato for the third time, saying it has concerns over the clinical evidence and economic model for the drug, for treating adults with major depression that is resistant to treatment.