Ramsey Baghdadi
When it rains, it pours.
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.
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.’
In its latest attempt to curtail generic versions of Hetlioz, Vanda Pharmaceuticals asked FDA Commissioner Martin Makary to reverse a previous agency decision upholding two ANDA approvals, claiming an “unacceptable culture of bias toward approving generic drugs” at the agency.
Pink Sheet reporter and editors discuss the US FDA’s changes to the COVID-19 vaccine indication and its revocation of the vaccine emergency use authorizations, as well as new vaccine coverage and reimbursement questions.
Health Canada has approved four new drugs and 12 label variations so far this year via Project Orbis, a combined figure that already exceeds the annual approval figures for the two previous years. The agency explains the factors that impact annual approvals and highlights the pathway’s benefits.