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.’
Sarepta's rAAVrh74 vector, used in the marketed Duchenne muscular dystrophy gene therapy Elevidys and across the company's limb girdle muscular dystrophy pipeline, earned a platform designation as the lead LGMD candidate prepares for BLA filing.
Pink Sheet reporter and editors discuss the potential impact of the Most-Favored Nation drug pricing proposal on Europe, the United States, as well as the pharmaceutical industry.
Recent and upcoming US FDA advisory committee meetings and a summary of the topics covered.
