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Submit Your Investigational New Drug (IND) Application and Clinical Holds (9/14) REdI 2017 

U.S. Food and Drug Administration
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Judit Milstein describes practical aspects of the IND submission and the sponsor’s and agency’s expectations during the first 30days after the initial IND submission. She also describes the grounds and procedures for imposition of a clinical hold, including practical aspects of this notification and subsequent steps to provide for the lifting of the clinical hold.
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FDA CDER’s Small Business and Industry Assistance (SBIA) educates and provides assistance in understanding the regulatory aspects of human drug products & clinical research.
Upcoming training and free continuing education credits: www.fda.gov/cd...
CDER SBIA 2017 Playlist: • 2017 CDER Small Busine...
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Training resources: www.fda.gov/cd...
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CDER small business e-mail update subscription: updates.fda.go...
Email: CDERSBIA@fda.hhs.gov
Phone: (301) 796-6707 I (866) 405-5367

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5 авг 2020

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