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Overview of FDA Expedited Development and Approval Programs for Serious Conditions

Impact Pharmaceutical Services

MAY 4, 2022

In May of 2014 and February of 2019 , the FDA released final Guidance for Industry outlining the Agency’s policies and procedures regarding expedited development and review programs for new drugs and biologics intended to treat serious or life-threatening conditions. Image courtesy of qimono at pixabay.com.

FDA

FDA Documentation Communication

Prominent Reasons Behind The Failure Of NAMPT inhibitors And Key Strategies Adopted By Developers To Overcome Such Challenges

Roots Analysis

NOVEMBER 3, 2023

As a starting point, the information on terminated, suspended and withdrawn trials was collated from clinicaltrials.gov and PubMed using relevant search keywords. Further, we identified the key parameters / strategies that, we believe, are likely to have a significant impact on the FDA approval of NAMPT inhibitors.

FDA

Overview of FDA Expedited Development and Approval Programs for Serious Conditions

Prominent Reasons Behind The Failure Of NAMPT inhibitors And Key Strategies Adopted By Developers To Overcome Such Challenges

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