Pfizer’s Xalkori sailed through FDA without an advisory committee review. But FDA did consult with two outside advisors--including the Oncology Committee Chair--along the way.
Michael McCaughan
The Office of Oncology & Hematology Products in FDA has been moving products through the NDA review stage at a record pace in 2011
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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.’
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Decision in AstraZeneca’s lawsuit against the Health and Human Services Department is a precedent-setting victory for the government and a blow to manufacturer efforts to block the price negotiation program.
Advisory committee for Capricor’s deriamocel planned, regenerative medicine advanced therapy designations proliferate for osteoarthritis, and the ranks of dual RMAT/breakthrough therapy designation holders grow.
