Profile

MR Andre Pearson

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United States

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1 to 2 of 2 total

CMC requirements

Posted By Andre Pearson 28-Nov-2012 07:30
Found In Egroup: Regulatory Open Forum \ view thread
How are the CMC requirements different for phase I, phase II, and phase III? Thanks. Andre ------------------------------------------- Andre Pearson BIOTECH GENERICS LLC Brooklyn NY United States -------------------------------------------

CMC Meetings

Posted By Andre Pearson 28-Nov-2012 07:27
Found In Egroup: Regulatory Open Forum \ view thread
What are some CMC clinical hold issues for an antibiotic (solid dosage form) IND? How are these issues addressed during an FDA meeting? Thanks. ------------------------------------------- Andre Pearson BIOTECH GENERICS LLC Brooklyn NY United States --------------------------------- ...