Refuse-to-file letters used to be extremely rare events, but as FDA data show, that's not necessarily the case anymore. In fiscal years 2003 through 2005, FDA issued no more than four refuse-to-file letters, with three such actions taken in 2004. But in 2006 and 2007, the numbers rise sharply; FDA sent seven letters in 2006 and 11 letters, including one for a biologic application, last year.
Ramsey Baghdadi
When it rains, it pours.
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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.’
HHS and its agencies violated the law by swiftly implementing “sweeping and poorly thought-through directives that ordered the bulk removal of healthcare resources,” including FDA draft guidances on diversity action plans and sex differences in clinical trials, a federal court said.
The legislation expected to be signed by President Trump is a mixed bag for pharmaceutical manufacturers depending on their product mix and manufacturing situation.
Industry associations EFPIA, EUCOPE and EURORDIS have praised the European Commission’s newly launched life sciences strategy, which will see investment funnelled into improving the clinical trial ecosystem and supporting advanced therapy development.
