Close meeting with U. S. Food and Drug Administration for new drug development
Mao Yuan-sheng
Abstract
Mao Yuan-sheng
Abstract
When a new drug goes into clinical trials stage,the U.S.Food and Drug Administration(FDA) starts its oversight.Sponsor is able to request meeting with FDA for comments in order to comply with related regulations.According to an authoritative survey,the more meeting with FDA is requested by sponsor,the higher rate of first-round approval achieves.This article introduces the close meetings between FDA and sponsor.
A significance statement is not available in the OpenAlex record.
A contribution statement is not available in the OpenAlex record.
Method details are not available in the OpenAlex metadata.
Findings are not separately available in the OpenAlex metadata.
Limitations are not available in the OpenAlex metadata.
Application details are not available in the OpenAlex metadata.
When a new drug goes into clinical trials stage,the U.S.Food and Drug Administration(FDA) starts its oversight.Sponsor is able to request meeting with FDA for comments in order to comply with related regulations.According to an authoritative survey,the more meeting with FDA is requested by sponsor,the higher rate of first-round approval achieves.This article introduces the close meetings between FDA and sponsor.
Key concepts: Food and drug administration, Drug, Drug approval, New drug application, Medicine, Drug administration, Administration (probate law), Clinical trial