The pharmaceutical regulatory process:
Saved in:
| Format: | Book |
|---|---|
| Language: | English |
| Published: |
New York [u.a.]
Informa Healthcare
2008
|
| Edition: | 2. ed. |
| Series: | Drugs and the pharmaceutical sciences
185 |
| Subjects: | |
| Online Access: | Inhaltsverzeichnis |
| Item Description: | Includes bibliographical references and index |
| Physical Description: | X, 469 S. Ill., graph. Darst. |
| ISBN: | 9781420070422 1420070428 9781420058680 1420058681 |
Staff View
MARC
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| 245 | 1 | 0 | |a The pharmaceutical regulatory process |c ed. by Ira R. Berry ... |
| 250 | |a 2. ed. | ||
| 264 | 1 | |a New York [u.a.] |b Informa Healthcare |c 2008 | |
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Record in the Search Index
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| adam_text | Titel: The pharmaceutical regulatory process
Autor: Berry, Ira R.
Jahr: 2008
^^fl Contents
Preface Hi
Contributors ix
PART I LEGAL REQUIREMENTS FOR REGULATORY COMPLIANCE
1. Pharmaceutical Regulation Before and After the Food, Drug,
and Cosmetic Act 1
John P. Swann
2. Modernizing the Food and Drug Administration 29
Arthur Y. Tsien, Esq.
3. The New Drug-Approval Process—Before and After 1962 45
Michael P. Peskoe
4 Generic Drug-Approval Process: Hatch-Waxman Update 61
Marc S. Gross, Jay Lessler, S. Peter Ludwig, and Amanda L. Vaught
5. FDA Regulation of Biological Products 103
Michael S. Labson, Krista Hessler Carver, and Marie C. Boyd
6. FDA s Antibiotic Regulatory Scheme: Then and Now 131
Irving L. Wiesen, Esq.
7» Generic Drugs in a Changing Intellectual Property Landscape 143
Neil F. Greenblum, Esq., Michael J. Fink, Esq., Stephen M. Roylcmce, Esq.,
P. Branko Pejic, Esq., Sean Myers-Payne, Es j., and Paul A. Braier, Esq.
8. The Influence of the Prescription Drug User Fee Act on the Approval
Process 181
Marc J. Scheineson, Esq.
9 Clinical Research Requirements for New Drug Applications 199
Gary L. Yingling, Esq., and Ann M. Begley, Esq.
1O. Postapproval Marketing Practices Regarding Drug Safety and
Pharmacovigilance 217
Robert P. Martin
vii
viii Contents
XX. Drugs Marketed Without FDA Approval 229
jane Baluss and David Rosen
XX. FDA Regulation of Foreign Drug Imports: The Need for Improvement 237
Benjamin L. England
PART II REGULATORY REQUIREMENTS FOR PRODUCT APPROVALS AND
AFTER
13. Active Pharmaceutical Ingredients 255
Max S. Lazar
14. Obtaining Approval of New Drug Applications and Abbreviated New
Drug Applications from a Chemistry, Manufacturing, and Controls
Perspective 269
Dhiren N. Shah
15. Obtaining Approval of a Generic Drug, Pre-1984 to the Present 283
Loren Gelber
16. New Developments in the Approval and Marketing of Nonprescription or
OTC Drugs 313
William j. Mead
XT. Current Good Manufacturing Practice and the Drug Approval Process 325
Ira R. Berry
18. The Influence of the USP on the Drug Approval Process 335
Edward M. Cohen
19. Ways, Means, and Evolving Trends in the U.S. Registration of Drug
Products from Foreign Countries 349
Alberto Grignolo
20. Impact of Government Regulation on Prescription Drug Marketing and
Promotion 371
Daniel Classman, Gene Goldberg, and Barbara Spallitta
21. CMC Postapproval Regulatory Affairs: Constantly Managing Change ill
Leo j. Lucisano, Kevin A. Miller, and Lorien Armour
XX. Living with 21 CFR Part 11 Compliance 429
Richard L. Burcham
Index 455
|
| any_adam_object | 1 |
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| bvnumber | BV035770738 |
| ctrlnum | (OCoLC)259902129 (DE-599)BVBBV035770738 |
| dewey-full | 344.7304233 |
| dewey-hundreds | 300 - Social sciences |
| dewey-ones | 344 - Labor, social, education & cultural law |
| dewey-raw | 344.7304233 |
| dewey-search | 344.7304233 |
| dewey-sort | 3344.7304233 |
| dewey-tens | 340 - Law |
| discipline | Rechtswissenschaft |
| edition | 2. ed. |
| format | Book |
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| geographic | USA |
| geographic_facet | USA |
| id | DE-604.BV035770738 |
| illustrated | Illustrated |
| indexdate | 2024-07-09T22:04:09Z |
| institution | BVB |
| isbn | 9781420070422 1420070428 9781420058680 1420058681 |
| language | English |
| oai_aleph_id | oai:aleph.bib-bvb.de:BVB01-018630443 |
| oclc_num | 259902129 |
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| physical | X, 469 S. Ill., graph. Darst. |
| publishDate | 2008 |
| publishDateSearch | 2008 |
| publishDateSort | 2008 |
| publisher | Informa Healthcare |
| record_format | marc |
| series | Drugs and the pharmaceutical sciences |
| series2 | Drugs and the pharmaceutical sciences |
| spelling | The pharmaceutical regulatory process ed. by Ira R. Berry ... 2. ed. New York [u.a.] Informa Healthcare 2008 X, 469 S. Ill., graph. Darst. txt rdacontent n rdamedia nc rdacarrier Drugs and the pharmaceutical sciences 185 Includes bibliographical references and index Pharmacy / Law and legislation / United States Drugs / Law and legislation / United States Legislation, Drug / United States Guideline Adherence / legislation & jurisprudence / United States Pharmaceutical Preparations / standards / United States Recht USA Berry, Ira R. Sonstige oth Drugs and the pharmaceutical sciences 185 (DE-604)BV000002008 185 HBZ Datenaustausch application/pdf http://bvbr.bib-bvb.de:8991/F?func=service&doc_library=BVB01&local_base=BVB01&doc_number=018630443&sequence=000002&line_number=0001&func_code=DB_RECORDS&service_type=MEDIA Inhaltsverzeichnis |
| spellingShingle | The pharmaceutical regulatory process Drugs and the pharmaceutical sciences Pharmacy / Law and legislation / United States Drugs / Law and legislation / United States Legislation, Drug / United States Guideline Adherence / legislation & jurisprudence / United States Pharmaceutical Preparations / standards / United States Recht |
| title | The pharmaceutical regulatory process |
| title_auth | The pharmaceutical regulatory process |
| title_exact_search | The pharmaceutical regulatory process |
| title_full | The pharmaceutical regulatory process ed. by Ira R. Berry ... |
| title_fullStr | The pharmaceutical regulatory process ed. by Ira R. Berry ... |
| title_full_unstemmed | The pharmaceutical regulatory process ed. by Ira R. Berry ... |
| title_short | The pharmaceutical regulatory process |
| title_sort | the pharmaceutical regulatory process |
| topic | Pharmacy / Law and legislation / United States Drugs / Law and legislation / United States Legislation, Drug / United States Guideline Adherence / legislation & jurisprudence / United States Pharmaceutical Preparations / standards / United States Recht |
| topic_facet | Pharmacy / Law and legislation / United States Drugs / Law and legislation / United States Legislation, Drug / United States Guideline Adherence / legislation & jurisprudence / United States Pharmaceutical Preparations / standards / United States Recht USA |
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