Day: August 1, 2019

The general quality expectations for clinical trials are described in a new ICH guidance adopted by the FDA this week. The concept of Quality-by-Design (QbD) has been the gold standard for defining quality expectations in manufacturing operations but similar standards lack for the conduct of clinical trials. It is generally accepted that the quality of … Read more

Manufacturers of breakthrough therapy (BTD) products often face challenges meeting all the CMC requirements for the NDA/BLA for their product. Similar issues are faced by those developing new products under the PRIME program in EU. This week the regulators published a detailed discussion using case studies on how manufacturers can satisfy regulatory requirements in the … Read more