Connaught Labs' Feb. 23 withdrawal of its diptheria-tetanus-pertussis vaccine adsorbed lot number 8M91039 was initiated after a routine quality assurance inspection. Connaught said it "determined that four vials of Inflogen, an inactivated equine influenza vaccine, in storage at the plant were incorrectly labeled as DTP." The company is coordinating withdrawal activities with FDA. The lot contained 45,909 vials, approximately 19,083 of which were shipped to 1,865 doctors, pharmacists and distributors. Each is being contacted by telephone and telegram, Connaught said. The firm added that there is no evidence that any vials containing Inflogen left the plant.
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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.’
Sponsors can expect faster evaluation processes for key medicines and greater support in mitigating medicines supply shortages this year as part of the European Medicines Agency’s digital transformation overhaul.
This is an update of recommendations from the European Medicines Agency's Committee for Medicinal Products for Human Use on the authorization of new medicines in the EU, and updates on EU marketing authorization changes recommended by the CHMP.
By stepping into the role of the Centers for Disease Control and Advisory Committee on Immunization Practices, HHS Secretary Robert F. Kennedy Jr. is causing further confusion and uncertainty about vaccine policy, experts say.
