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FDA Launches Pilot To Gain Practical Experience With 'Established Conditions' In Quality Assessments

 
• By Joanne S. Eglovitch

FDA is accepting applications from the pharmaceutical industry to pilot the use of established conditions proposed by sponsors in NDAs, ANDAS, BLAs and supplements. The purpose of the pilot is for FDA to gain practical experience in assessing proposed established conditions and to ensure that assessment decisions do not negatively impact user fee time frames.

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FDA has announced a new pilot program to test the concept of "established conditions" in quality assessments of drug applications.

The agency intends to gain experience from the pilot in assessing established conditions and to ensure that reviews do not affect user fee time frames. These established conditions must also...

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