An Overview of FDA Regulated Products (notice n° 15548)
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| 000 -LEADER | |
|---|---|
| fixed length control field | 02618cam a2200277zu 4500 |
| 003 - CONTROL NUMBER IDENTIFIER | |
| control field | FRCYB88864392 |
| 005 - DATE AND TIME OF LATEST TRANSACTION | |
| control field | 20250107104954.0 |
| 008 - FIXED-LENGTH DATA ELEMENTS--GENERAL INFORMATION | |
| fixed length control field | 250107s2018 fr | o|||||0|0|||eng d |
| 020 ## - INTERNATIONAL STANDARD BOOK NUMBER | |
| International Standard Book Number | 9780128111550 |
| 035 ## - SYSTEM CONTROL NUMBER | |
| System control number | FRCYB88864392 |
| 040 ## - CATALOGING SOURCE | |
| Original cataloging agency | FR-PaCSA |
| Language of cataloging | en |
| Transcribing agency | |
| Description conventions | rda |
| 100 1# - MAIN ENTRY--PERSONAL NAME | |
| Personal name | Pacifici, Eunjoo |
| 245 01 - TITLE STATEMENT | |
| Title | An Overview of FDA Regulated Products |
| Remainder of title | From Drugs and Cosmetics to Food and Tobacco |
| Statement of responsibility, etc. | ['Pacifici, Eunjoo'] |
| 264 #1 - PRODUCTION, PUBLICATION, DISTRIBUTION, MANUFACTURE, AND COPYRIGHT NOTICE | |
| Name of producer, publisher, distributor, manufacturer | Elsevier Science |
| Date of production, publication, distribution, manufacture, or copyright notice | 2018 |
| 300 ## - PHYSICAL DESCRIPTION | |
| Extent | p. |
| 336 ## - CONTENT TYPE | |
| Content type code | txt |
| Source | rdacontent |
| 337 ## - MEDIA TYPE | |
| Media type code | c |
| Source | rdamdedia |
| 338 ## - CARRIER TYPE | |
| Carrier type code | c |
| Source | rdacarrier |
| 520 ## - SUMMARY, ETC. | |
| Summary, etc. | Today's challenge, especially for many newcomers to the regulated industry, is not necessarily to gather regulatory information, but to know how to interpret and apply it. The ability to discern what is important from what is not, and to interpret regulatory documents correctly, provides a valuable competitive advantage to any newcomer or established professional in this field. An Overview of FDA Regulated Products: From Drugs and Medical Devices to Food and Tobacco provides a valuable summary of the key information to unveil the meaning of critical, and often complex, regulatory concepts. Concise and easy to read with practical explanations, key points, summaries and case studies, this book highlights the regulatory processes involved in bringing an FDA regulated product from research and development to approval and market. Although the primary focus will be on the US system, this book also features global perspectives where appropriate. A valuable resource for students, professors and professionals, An Overview of FDA Regulated Products illustrates the most important elements and concepts so that the reader can focus on the critical issues and make the necessary connections to be successful. Provides an overview of key regulatory requirements using a practical approach that features detailed discussions of hypothetical and real-world case studies in order to highlight the concepts and applications of regulations Covers all FDA regulated products, including drugs, biologics, medical devices, cosmetics, foods, dietary supplements, cosmetics, veterinary products, tobacco and more in one single reference Illustrates complex topics in a clear, succinct and engaging manner by breaking down technical terms and offering straightforward and easy to understand explanations |
| 650 #0 - SUBJECT ADDED ENTRY--TOPICAL TERM | |
| Topical term or geographic name entry element | |
| 700 0# - ADDED ENTRY--PERSONAL NAME | |
| Personal name | Pacifici, Eunjoo |
| 856 40 - ELECTRONIC LOCATION AND ACCESS | |
| Access method | Cyberlibris |
| Uniform Resource Identifier | <a href="https://international.scholarvox.com/netsen/book/88864392">https://international.scholarvox.com/netsen/book/88864392</a> |
| Electronic format type | text/html |
| Host name | |
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