The Pharmaceutical Regulatory Process
This Second Edition examines the mechanisms and means to establish regulatory compliance for pharmaceutical products and company practices. It focuses on major legislative revisions that impact requirements for drug safety reviews, product regulatory approvals, and marketing practices. Written by to...
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| フォーマット: | 図書 |
| 言語: | 英語 |
| 出版事項: |
New York
Informa Healthcare USA Inc.
2021
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| 版: | 2nd ed. |
| シリーズ: | Drugs and The Pharmaceutical Sciences Series
Vol. 185 |
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| 要約: | This Second Edition examines the mechanisms and means to establish regulatory compliance for pharmaceutical products and company practices. It focuses on major legislative revisions that impact requirements for drug safety reviews, product regulatory approvals, and marketing practices. Written by top industry professionals, practicing attorneys, and FDA regulators, it includes policies and procedures that pharmaceutical companies need to implement regulatory compliance post-approval. |
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| 物理的記述: | x, 469 p. |
| ISBN: | 9780367202842 |