New Drug Applications

by LandMark Publications

THIS CASEBOOK contains a selection of U. S. Court of Appeals decisions that analyze and discuss issues stemming from new drug applications filed with the U. S. Food and Drug Administration. * * * Prescription drugs in the United States must be approved by the Food and Drug Administration (FDA) before they can be sold. 21 U.S.C. 355(a). Prospective drugs can follow one of two general paths to obtain FDA approval. A new drug that has never been marketed...

• Format: Paperback
• Language: English
• ISBN: 1983339296
• ISBN13: 9781983339295
• Release Date: July 2018
• Publisher: Independently Published
• Length: 542 Pages
• Weight: 1.58 lbs.
• Dimensions: 1.1" x 6.0" x 9.0"