Pre-ANDA strategy and human factors activities to de-risk pharmaceutical companies ANDA submission of drug-device combination products: case study of a …
L Brunet-Manquat, A Combedazou… - Expert Opinion on …, 2024 - Taylor & Francis
Background This article presents a strategy that a Drug Delivery Device Developer (DDDD)
has adopted to support Abbreviated New Drug Application (ANDA) submissions of drug …
has adopted to support Abbreviated New Drug Application (ANDA) submissions of drug …