Home » Draft Guidance Issued on BiMo PMA Applications, Inspections
Draft Guidance Issued on BiMo PMA Applications, Inspections
July 18, 2006
The FDA published draft guidance June 20 to help devicemakers understand the process for the review of clinical and nonclinical information in premarket approval (PMA) applications and related inspections under the bioresearch monitoring (BiMo) program.
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