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A drug that receives___________ designation is eligible for early and more frequent meetings with FDA to discuss the drug's development plan, and is also eligible
A drug that receives___________ designation is eligible for early and more frequent meetings with FDA to discuss the drug's development plan, and is also eligible for submitting completed sections of NDA for review by FDA, rather than submitting the completed NDA at one time (rolling submissions)
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Management Fundamentals
Authors: Robert N. Lussier
10th Edition
1071891375, 978-1071891377
