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The European Medicines Agency March 11 published the first risk-management plan summary for Piramal Imaging’s molecular imaging agent NeuraCeq (florbetaben (18F)), used to detect ? amyloid plaques in the brain, a protein associated with Alzheimer’s disease. Read More
Manufacturers of influenza vaccine in the EU must file strain variation applications for next year’s flu season by June 16, the European Medicines Agency says. Read More
Massachusetts doctors who want to prescribe the painkiller Zohydro will need to complete a risk-assessment and pain management treatment agreement with their patients, under sweeping restrictions announced Tuesday by Gov. Deval Patrick (D). Read More
The European Medicines Agency is tightening stability testing requirements for drugmakers submitting applications for significant post-approval manufacturing changes that involve active substances. Read More
Hospira’s quality struggles continue as the injectable giant voluntarily recalled seven lots of generic anesthetic propofol due a defect that led to metal particles in certain vials. Read More
The European Medicines Agency is looking into potential heart risks linked to testosterone-containing drugs after an EU member state regulator raised safety concerns. Read More
Drugmakers and distributors are asking the FDA to delay strict enforcement of federal track-and-trace requirements, since most companies won’t be able to meet the first deadlines for exchanging transaction data. Read More
Drugmakers should include information for all uses of a product — including off-label uses — when preparing periodic benefit-risk evaluation reports, the International Council on Harmonisation says in new Q&A guidance. Read More
The drug industry isn’t happy with the FDA’s decision to use actual direct-to-consumer (DTC) ads as part of a study looking at whether companies present too much risk information in prescription drug ads. Read More
The European Medicines Agency said late last week that additional drugs have been diverted in a still unfolding case of product tampering that began with stolen vials of the cancer drug Herceptin (trastuzumab). Read More
Hospira’s quality struggles continue as the injectable giant voluntarily recalled seven lots of generic anesthetic propofol due a defect that led to metal particles in certain vials. Read More