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The FDA handed Galena Biopharma a 10-item Form 483 for lapses in adverse drug event reporting — some of them repeat observations — following a reinspection of its Portland, Ore., facility. Read More
The UK’s healthcare costs regulator Tuesday launched the Office of Market Access, providing drugmakers with a dedicated team to address queries about cost-benefit assessments. Read More
The FDA is seeking feedback on the chemistry, manufacturing and controls information that it wants drugmakers to include in INDs for gene therapies containing microbial vectors. Read More
The European Medicines Agency’s decision to redact certain personal and commercial information from clinical study reports before releasing them to a private citizen did not violate EU transparency policy, the European ombudsman says. Read More
European regulators have granted accelerated assessment for GlaxoSmithKline’s antiseptic chlorhexidine gel for the prevention of umbilical cord infections. Read More