Category Archives: Regulatory

GSK Submits Malaria Vaccine Candidate for EMA Approval

GSK announced that it has submitted a regulatory filing to the European Medicines Agency (EMA) for its malaria vaccine candidate, RTS,S. RTS,S is intended for use against the Plasmodium falciparum malaria parasite, which is most prevalent in sub-Saharan Africa (SSA). It is estimated that malaria accounts for approximately 90% of deaths in SSA, of which 77% occur […]
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Catching Biopharmaceutical Sponsors by Surprise

The FDA has always been concerned about the safety of patients, and they strongly believe that clinical trials are not sufficient to capture all drug related adverse effects. During an update on The Future of FDA’s Drug Safety Program, Andrew C. von Eschenbach stated, “The full magnitude of some potential risks does not always emerge […]
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Compounding Pharmacy Issues Recall, But Challenges FDA Decision

FDA has posted on www.fda.gov a July 19, 2014 press statement from Unique Pharmaceuticals, which reports a voluntary nationwide recall of all sterile drug preparations compounded by the outsourcing facility that have not reached the expiration date listed on the products.
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EFPIA’s “Integrated Strategy”: Out of the Frying Pan, Into the Fire?

It’s difficult to open an email or an envelope in Brussels these days without yet another agenda falling out of it, carrying the promise of a new start. With a new European Parliament installed, a new European Commission president appointed and a new Commission on the way, and guarded optimism that the worst of the […]
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EMA Responds Robustly to Conflict-of-Interest Claims

By Philip Ward, Applied Clinical Trials. The European Medicines Agency (EMA) has insisted that the concerns raised about its scientific advice given to pharmaceutical companies stem from a flawed understanding of the activities of the agency and its partners in this area.
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