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Reckitt Benckiser is voluntarily recalling 1.5 million units of four varieties of its Mucinex liquid cold medicines nationwide because the back labels may not show they contain acetaminophen and other active ingredients. Read More
The FDA slapped warning letters on two more drug outsourcing facilities for sloppy sterile processing, bringing to seven the number of compounders cited for sterile manufacturing deviations in the past six months. Read More
The FDA’s Office of Pharmaceutical Quality is developing a new inspection protocol that will focus on expert investigator-developed questions and assessment practices. Read More
Canadian biotech company Tekmira is set to restart a Phase I trial of its TKM-Ebola RNA interference therapy in the coming weeks, after the FDA downgraded a partial clinical hold that allows the company to administer repeat doses not greater than 0.24 mg/kg/day. Read More
Drugmakers can reduce the time it takes to obtain marketing authorization from EU regulators by about two months if they seek scientific advice and make suggested changes to their clinical development plans, a new analysis shows. Read More
The FDA is advising devicemakers that plan to support a premarket submission with data from clinical studies conducted outside the U.S. to meet with the agency before finalizing their trial designs. Read More
The FDA saw an 11 percent increase in inspections carried out as part of a sweeping program to improve inspectors’ understanding of clinical practices during fiscal year 2014. Read More