FDA has issued regulations governing IND products to protect human subjects enrolled in clinical trials. For example, in 21 CFR part 312, sponsors must submit chemistry, manufacturing and control (CMC) information on a drug or biological product as part of an IND application (§ 312.23(a)(7)).
cGMP: Strategies for Implementation and Compliance for Phase I Investigational Drug and Biologic Products - Webinar by GlobalCompliancePanel
9 January 2014, Fremont, United States
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Online Training, 161 Mission Falls Lane, Suite 216, Fremont, 94539, United States
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