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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| Autres auteurs: | , |
|---|---|
| Format: | Livre |
| Langue: | anglais |
| Publié: |
New York
Informa Healthcare USA Inc.
2021
|
| Édition: | 2nd ed. |
| Collection: | Drugs and The Pharmaceutical Sciences Series
Vol. 185 |
| Sujets: | |
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| 245 | |a The Pharmaceutical Regulatory Process | ||
| 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. | ||
| 650 | |a Pharmacy - Law and Legislation - United States |9 7524 | ||
| 650 | |a Drugs - Law and Legislation |9 8272 | ||
| 700 | |a Berry, Ira R. |9 8386 | ||
| 700 | |a Martin, Robert P. |9 7824 | ||