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fda’s drug review process and the package label: strategies for writing successful fda submissions
The book reproduces comments and complaints from FDA reviewers regarding data that are fragmentary, ambiguous, or that detract from the drug’s approvability, and the book reveals how sponsors overcame FDA’s concerns and how sponsors succeeded in persuading FDA to grant approval of the drug.
Tom Brody
2019
fda’s drug review process and the package label: strategies for writing successful fda submissions
The book reproduces comments and complaints from FDA reviewers regarding data that are fragmentary, ambiguous, or that detract from the drug’s approvability, and the book reveals how sponsors overcame FDA’s concerns and how sponsors succeeded in persuading FDA to grant approval of the drug.
Tom Brody
2019
| Weight | 2.11 kg |
|---|---|
| Dimensions | 7.75 × 1.25 × 10 cm |
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