Pharmaceutical quality assessment - The new chemistry, manufacturing, and controls (CMC) review paradigm in the 21st century

• In: S4 - Chemistry and Good Manufacturing Practice on Wednesday, 7 September 2005, 9:00-12:00
• At: Cairo (Egypt) (2005)
• Type: Presentation
• By: NASR, Moheb (US FDA, Office of New Drug Chemistry (ONDC), Rockville, MD, United States of America)
• Abstract:

  The U.S. Food and Drug Administration (FDA), Center for Drug Evaluation and Research, Office of New Drug Chemistry (ONDC) is responsible for reviewing the chemistry, manufacturing, and controls (CMC) section of new drug applications. Consistent with the FDA’s initiative concerning modernization of the regulation of pharmaceutical manufacturing

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