New Drug Development: A Regulatory Overview |
Contents
The New Drug Approval Process A Primer A | 1 |
Nonclinical Drug Testing | 15 |
FDA Standards for Nonclinical Testing Good Laboratory Practice GLP | 35 |
Copyright | |
17 other sections not shown
Common terms and phrases
According action active addition adequate administration adverse advisory committee agency amendment analysis animal application appropriate approval assessment authority CDER changes clinical investigation clinical studies clinical trials completed conduct considered contain Content copy decision described designed determine discussion disease division document dosage dose drug product drug review drug's early effects ensure establishment Evaluation experience facility FDA's federal fees final Guideline human identify important indication initial inspections intended involved issues labeling laboratory letter manufacturing marketing meeting methods monitoring needed nonclinical obtain Office orphan patients period Phase present procedures proposed protocol receive records regulations regulatory relevant reports request requirements responsibilities risks safety serious significant specific sponsor standards statement subjects submission submitted summary supplements testing therapies tion toxicity treatment types United