Newsletter - August 1, 2019
FDA Offers Practical Tips on How to Address CMC for BTD Products
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...Read More
FDA’s Quality by Design (QBD) Guidance for Clinical Trials
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...Read More
FDA Offers Practical Tips on How to Address CMC for BTD Products
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...Read More
FDA’s Quality by Design (QBD) Guidance for Clinical Trials
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...Read More
