Introduce New GMP Rules Step-By-Step To Reduce Burden On Companies
This article was originally published in PharmAsia News
Executive SummaryCSPC Pharma Chairman Cai Dong-Cheng submitted suggestions regarding the step-by-step implementation of new GMP regulations Mar. 7
You may also be interested in...
The amyloid-targeting drug is years behind Biogen/Eisai’s aducanumab, but its subcutaneous administration and the GRADUATE studies’ design could give Roche’s gantenerumab an advantage.
Correvio's atrial fibrillation drug Brinavess will return to a US FDA advisory committee more than a decade after the agency first declined to approve the drug; FDA still has a series of cardiovascular safety concerns related to the drug and is not convinced by data from the European experience.
FerGene bladder cancer therapy achieved a complete response in more than half of patients in its pivotal trial. The joint venture now looks to commercialization and potential expansion of indications.