2010•Chinese Journal of New Drugs and Clinical RemediesRequires access

Close meeting with U. S. Food and Drug Administration for new drug development

Mao Yuan-sheng

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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.

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What this paper is about

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.

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Available 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.

Key concepts: Food and drug administration, Drug, Drug approval, New drug application, Medicine, Drug administration, Administration (probate law), Clinical trial

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