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Drugmakers should implement and maintain security procedures for electronic safety-and-acknowledgement messages over the internet, according to a European draft guidance that provides technical requirements around online data protection. Read More
Manufacturers should include effective evaluation and verification studies in their process validation documentation when obtaining biotechnology-derived proteins in the EU, according to a new guidance from the European Medicines Agency (EMA). Read More
The FDA on Monday approved UK-based NOVA Laboratories’ oral suspension drug for the treatment of patients with acute lymphoblastic leukemia (ALL) as part of a combination regimen. Read More
The European Medicines Agency (EMA) says the EU’s EudraVigilance database received more than 1 million post-marketing expedited adverse-drug-reaction (ADR) reports in 2013. Read More
A European Medicines Agency committee on Friday recommended approval of GlaxoSmithKline’s melanoma drug Mekinist, the first of its kind treatment that selectively targets the MEK protein kinase. Read More
The European Medicines Agency (EMA) is considering new trial designs using pathologic complete response (pCR) as an endpoint in neoadjuvant breast cancer studies for patients with aggressive, early stage breast cancer. Read More
Drugmakers providing postmarket benefit-risk assessments to Health Canada will soon need to follow rigid, standardized guidelines that provide both preapproval and postapproval data about a drug product’s efficacy. Read More
The European Commission is moving toward putting new restrictions on drugs that contain domperidone, removing the EC’s approval of the drugs for treatment of bloating and heartburn due to increased heart risks. Read More