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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Tác giả chính: | |
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Tác giả khác: | |
Định dạng: | Sách |
Ngôn ngữ: | Tiếng Anh |
Được phát hành: |
New York
Informa Healthcare USA Inc.
2021
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Phiên bản: | 2nd ed. |
Loạt: | Drugs and The Pharmaceutical Sciences Series
Vol. 185 |
Những chủ đề: | |
Các nhãn: |
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250 | |a 2nd ed. | ||
260 | |a New York |b Informa Healthcare USA Inc. |c 2021 | ||
300 | |a x, 469 p. | ||
490 | |a Drugs and The Pharmaceutical Sciences Series |v Vol. 185 | ||
520 | |a 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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650 | |a Drugs - Law and Legislation | ||
700 | |a Berry, Ira R. |9 8386 | ||
700 | |a Martin, Robert P. |9 9253 | ||
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