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42ND COMPREHENSIVE R E V I E W C O U R S E I N PM R MARCH 29 APRIL 6, 2008, Marriott Medical Center Hotel 6580 Fannie Street Houston, TX 77030 Presented by Physical Medicine & Rehabilitation Alliance
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What is nd c r eview?
nd c r eview stands for new drug application and biologic licensing review.
Who is required to file nd c r eview?
Any pharmaceutical company submitting a new drug application or biologic licensing review is required to file nd c r eview.
How to fill out nd c r eview?
nd c r eview must be filled out electronically through the appropriate regulatory agency's online portal.
What is the purpose of nd c r eview?
The purpose of nd c r eview is to evaluate the safety, efficacy, and quality of a new drug or biologic product before it can be approved for marketing and sale.
What information must be reported on nd c r eview?
nd c r eview requires detailed information on the manufacturing process, clinical trial results, safety data, and labeling of the drug or biologic product.
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