Pharmaceutical compliance and enforcement answer book:
Gespeichert in:
| Weitere Verfasser: | |
|---|---|
| Format: | Buch |
| Sprache: | English |
| Veröffentlicht: |
New York City
Practising Law Institute
[2017]
|
| Ausgabe: | 2017 edition |
| Schlagworte: | |
| Beschreibung: | In question and answer format. - "#165574." |
| Beschreibung: | lxi, 608 Seiten 23 cm |
| ISBN: | 9781402428425 |
Internformat
MARC
| LEADER | 00000nam a2200000 c 4500 | ||
|---|---|---|---|
| 001 | BV043811132 | ||
| 003 | DE-604 | ||
| 005 | 20180220 | ||
| 007 | t | ||
| 008 | 161005s2017 |||| 00||| eng d | ||
| 020 | |a 9781402428425 |9 978-1-4024-2842-5 | ||
| 035 | |a (DE-599)BVBBV043811132 | ||
| 040 | |a DE-604 |b ger |e rda | ||
| 041 | 0 | |a eng | |
| 049 | |a DE-M382 | ||
| 245 | 1 | 0 | |a Pharmaceutical compliance and enforcement answer book |c edited by Howard L. Dorfman |
| 250 | |a 2017 edition | ||
| 264 | 1 | |a New York City |b Practising Law Institute |c [2017] | |
| 264 | 4 | |c © 2017 | |
| 300 | |a lxi, 608 Seiten |c 23 cm | ||
| 336 | |b txt |2 rdacontent | ||
| 337 | |b n |2 rdamedia | ||
| 338 | |b nc |2 rdacarrier | ||
| 500 | |a In question and answer format. - "#165574." | ||
| 505 | 8 | |a Literaturangaben und Index | |
| 505 | 8 | |a FDA enforcement pre- and post-approval -- FDA enforcement-facility inspections -- 483s and warning letters -- FDA regulations and enforcement actions relative to oversight of advertising and promotion -- Federal and state regulation and enforcement of pharmaceutical manufacturers' advertising and promotional activity -- Regulatory, compliance, and liability restrictions on off-label promotion -- Current status of the impact of the First Amendment on off-label promotion -- Food and Drug Administration Amendments Act of 2007 and the growth of FDA Enforcement Authority -- Risk Evaluation & Mitigation Strategies (REMS) & related post-market safety oversight -- Impact of FDA Regulatory & Compliance Oversight on product liability exposure of pharmaceutical manufacturers -- Specific FDA enforcement tools -- Criminal prosecution as a U.S. Food and Drug Adiminstration enforcement tool -- Pharmaceutical price reporting: the "ABCs" and "123s" of compliance -- The Foreign Corrupt Practices Act and its impact on the pharmaceutical industry | |
| 650 | 4 | |a Pharmacy / Law and legislation / United States / Miscellanea | |
| 650 | 4 | |a Drugs / Law and legislation / United States / Miscellanea | |
| 650 | 4 | |a Pharmaceutical industry / United States / Miscellanea | |
| 650 | 7 | |a Drugs / Law and legislation |2 fast | |
| 650 | 7 | |a Pharmaceutical industry |2 fast | |
| 650 | 7 | |a Pharmacy / Law and legislation |2 fast | |
| 650 | 4 | |a Recht | |
| 651 | 7 | |a United States |2 fast | |
| 651 | 4 | |a USA | |
| 700 | 1 | |a Dorfman, Howard L. |0 (DE-588)1153039419 |4 edt | |
| 999 | |a oai:aleph.bib-bvb.de:BVB01-029222384 | ||
Datensatz im Suchindex
| _version_ | 1804176659869335552 |
|---|---|
| any_adam_object | |
| author2 | Dorfman, Howard L. |
| author2_role | edt |
| author2_variant | h l d hl hld |
| author_GND | (DE-588)1153039419 |
| author_facet | Dorfman, Howard L. |
| building | Verbundindex |
| bvnumber | BV043811132 |
| contents | Literaturangaben und Index FDA enforcement pre- and post-approval -- FDA enforcement-facility inspections -- 483s and warning letters -- FDA regulations and enforcement actions relative to oversight of advertising and promotion -- Federal and state regulation and enforcement of pharmaceutical manufacturers' advertising and promotional activity -- Regulatory, compliance, and liability restrictions on off-label promotion -- Current status of the impact of the First Amendment on off-label promotion -- Food and Drug Administration Amendments Act of 2007 and the growth of FDA Enforcement Authority -- Risk Evaluation & Mitigation Strategies (REMS) & related post-market safety oversight -- Impact of FDA Regulatory & Compliance Oversight on product liability exposure of pharmaceutical manufacturers -- Specific FDA enforcement tools -- Criminal prosecution as a U.S. Food and Drug Adiminstration enforcement tool -- Pharmaceutical price reporting: the "ABCs" and "123s" of compliance -- The Foreign Corrupt Practices Act and its impact on the pharmaceutical industry |
| ctrlnum | (DE-599)BVBBV043811132 |
| edition | 2017 edition |
| format | Book |
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| geographic | United States fast USA |
| geographic_facet | United States USA |
| id | DE-604.BV043811132 |
| illustrated | Not Illustrated |
| indexdate | 2024-07-10T07:35:42Z |
| institution | BVB |
| isbn | 9781402428425 |
| language | English |
| oai_aleph_id | oai:aleph.bib-bvb.de:BVB01-029222384 |
| open_access_boolean | |
| owner | DE-M382 |
| owner_facet | DE-M382 |
| physical | lxi, 608 Seiten 23 cm |
| publishDate | 2017 |
| publishDateSearch | 2017 |
| publishDateSort | 2017 |
| publisher | Practising Law Institute |
| record_format | marc |
| spelling | Pharmaceutical compliance and enforcement answer book edited by Howard L. Dorfman 2017 edition New York City Practising Law Institute [2017] © 2017 lxi, 608 Seiten 23 cm txt rdacontent n rdamedia nc rdacarrier In question and answer format. - "#165574." Literaturangaben und Index FDA enforcement pre- and post-approval -- FDA enforcement-facility inspections -- 483s and warning letters -- FDA regulations and enforcement actions relative to oversight of advertising and promotion -- Federal and state regulation and enforcement of pharmaceutical manufacturers' advertising and promotional activity -- Regulatory, compliance, and liability restrictions on off-label promotion -- Current status of the impact of the First Amendment on off-label promotion -- Food and Drug Administration Amendments Act of 2007 and the growth of FDA Enforcement Authority -- Risk Evaluation & Mitigation Strategies (REMS) & related post-market safety oversight -- Impact of FDA Regulatory & Compliance Oversight on product liability exposure of pharmaceutical manufacturers -- Specific FDA enforcement tools -- Criminal prosecution as a U.S. Food and Drug Adiminstration enforcement tool -- Pharmaceutical price reporting: the "ABCs" and "123s" of compliance -- The Foreign Corrupt Practices Act and its impact on the pharmaceutical industry Pharmacy / Law and legislation / United States / Miscellanea Drugs / Law and legislation / United States / Miscellanea Pharmaceutical industry / United States / Miscellanea Drugs / Law and legislation fast Pharmaceutical industry fast Pharmacy / Law and legislation fast Recht United States fast USA Dorfman, Howard L. (DE-588)1153039419 edt |
| spellingShingle | Pharmaceutical compliance and enforcement answer book Literaturangaben und Index FDA enforcement pre- and post-approval -- FDA enforcement-facility inspections -- 483s and warning letters -- FDA regulations and enforcement actions relative to oversight of advertising and promotion -- Federal and state regulation and enforcement of pharmaceutical manufacturers' advertising and promotional activity -- Regulatory, compliance, and liability restrictions on off-label promotion -- Current status of the impact of the First Amendment on off-label promotion -- Food and Drug Administration Amendments Act of 2007 and the growth of FDA Enforcement Authority -- Risk Evaluation & Mitigation Strategies (REMS) & related post-market safety oversight -- Impact of FDA Regulatory & Compliance Oversight on product liability exposure of pharmaceutical manufacturers -- Specific FDA enforcement tools -- Criminal prosecution as a U.S. Food and Drug Adiminstration enforcement tool -- Pharmaceutical price reporting: the "ABCs" and "123s" of compliance -- The Foreign Corrupt Practices Act and its impact on the pharmaceutical industry Pharmacy / Law and legislation / United States / Miscellanea Drugs / Law and legislation / United States / Miscellanea Pharmaceutical industry / United States / Miscellanea Drugs / Law and legislation fast Pharmaceutical industry fast Pharmacy / Law and legislation fast Recht |
| title | Pharmaceutical compliance and enforcement answer book |
| title_auth | Pharmaceutical compliance and enforcement answer book |
| title_exact_search | Pharmaceutical compliance and enforcement answer book |
| title_full | Pharmaceutical compliance and enforcement answer book edited by Howard L. Dorfman |
| title_fullStr | Pharmaceutical compliance and enforcement answer book edited by Howard L. Dorfman |
| title_full_unstemmed | Pharmaceutical compliance and enforcement answer book edited by Howard L. Dorfman |
| title_short | Pharmaceutical compliance and enforcement answer book |
| title_sort | pharmaceutical compliance and enforcement answer book |
| topic | Pharmacy / Law and legislation / United States / Miscellanea Drugs / Law and legislation / United States / Miscellanea Pharmaceutical industry / United States / Miscellanea Drugs / Law and legislation fast Pharmaceutical industry fast Pharmacy / Law and legislation fast Recht |
| topic_facet | Pharmacy / Law and legislation / United States / Miscellanea Drugs / Law and legislation / United States / Miscellanea Pharmaceutical industry / United States / Miscellanea Drugs / Law and legislation Pharmaceutical industry Pharmacy / Law and legislation Recht United States USA |
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