CRO Quanticate invests in India, boosts workforce
Data-focused Quanticate has opened a 15,500 sq. ft. office in Bangalore, India.
Archives for September 26, 2017
US FDA says excessive Ocaliva poses risk to people with decreased liver function
The US FDA has warned that people with decreased liver function who taker higher than recommended doses of Intercept Pharma’s drug Ocaliva are at increased risk of liver injury and death.
Though willing, minorities still face barriers to clinical trial participation
Lack of trust has become less of a barrier to clinical trial participation, though more work needs to be done as information access and service levels receive low marks in a recent survey.
Divi's Labs gets US FDA Form 483 for Vizag API plant
The US FDA has found more problems at a Divi’s Laboratories Limited API facility that was banned from shipping to the US earlier this year.
The track & trace big question: Can we get around aggregation? Or should we get ready?
Implementing ‘aggregation’ – the term used to describe pharmaceutical product unit-to-case hierarchy – is not mandatory in Europe, however industry delegates say there is incentive to push its adoption.
Aurobindo hit with US FDA Form 483 for cephalosporin plant
Aurobindo Pharma Limited has received a Form 483 detailing two problems identified by US FDA inspectors who visited its Unit VI facility in in Chitkul Village, Andhra Pradesh, India.