FDA is designing a five-item grid as a management tool to explain its risk-benefit decisions in a new more concise format. The model that it has created as a working template confirms a truism about its drug approval tendencies that industry has suspected for years: the baseline for FDA approval is a high-rating of the severity of the disease being treated and the medical need for the product.
By Cole Werble
The severity of a medical condition and the need for a new treatment lead the list of factors the Food...
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Advanz Pharma would have had to show that the European Commission’s decision to revoke Ocaliva’s conditional marketing approval risked causing serious and irreparable harm, according to lawyers from Van Bael & Bellis.
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A new pilot aims to take Brazil closer to ‘digital transformation.’
There is a place for using external reference pricing to set prices of advanced therapies, but any such mechanism must take into account the specificities of the Brazilian market and health system.
Lerodalcibep and palbociclib are among the latest new drugs that the European Medicines Agency has started to review for potential EU marketing authorization.
Country recommends eights new drugs for approval, including six for rare diseases, and also announces macroeconomic policy the pharma industry says would enable some reimbursement prices to be raised.
