FDA regulatory affairs:
Saved in:
| Format: | Electronic eBook |
|---|---|
| Language: | English |
| Published: |
Boca Raton
Taylor & Francis
2014
|
| Subjects: | |
| Online Access: | TUM01 Volltext |
| Item Description: | Includes bibliographical references and index Overview of FDA and drug development / Josephine C. Babiarz and Douglas Pisano -- What is an IND? / Michael R. Hamrell -- The new drug application / Charles Monahan and Josephine C. Babiarz -- Meetings with the FDA / Alberto Grignolo and Sally Choe -- FDA medical device regulation / Barry Sall -- A primer of drug/device law : what is the law and how do I find it? / Josephine C. Babiarz -- The development of orphan drugs / Scott N. Freeman -- CMC sections of regulatory filings and CMC regulatory -- Compliance during investigational and postapproval stages / Prabu Nambiar, Steven R. Koepke, and Kevin Swiss -- Overview of the gxps for the regulatory professional / Bob Buckley, Robert Blanks, Kimberly J. White, and Tonya White-Salters -- FDA regulation of the advertising and promotion of prescription drugs, biologics, and medical devices / Karen L. Drake -- The practice of regulatory affairs / David S. Mantus -- FDA advisory / Christina A. McCarthy and David S. Mantus -- Biologics / Florence Kaltovich -- Regulation of combination products in the United States / John Barlow Weiner |
| Physical Description: | 1 Online-Ressource |
| ISBN: | 1841849197 1841849200 9781841849195 9781841849201 |
Staff View
MARC
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| dewey-ones | 615 - Pharmacology and therapeutics |
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| geographic | USA |
| geographic_facet | USA |
| id | DE-604.BV041989814 |
| illustrated | Not Illustrated |
| indexdate | 2024-07-10T01:10:01Z |
| institution | BVB |
| isbn | 1841849197 1841849200 9781841849195 9781841849201 |
| language | English |
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| publishDate | 2014 |
| publishDateSearch | 2014 |
| publishDateSort | 2014 |
| publisher | Taylor & Francis |
| record_format | marc |
| spelling | FDA regulatory affairs editors, Douglas J. Pisano, David Mantus Boca Raton Taylor & Francis 2014 1 Online-Ressource txt rdacontent c rdamedia cr rdacarrier Includes bibliographical references and index Overview of FDA and drug development / Josephine C. Babiarz and Douglas Pisano -- What is an IND? / Michael R. Hamrell -- The new drug application / Charles Monahan and Josephine C. Babiarz -- Meetings with the FDA / Alberto Grignolo and Sally Choe -- FDA medical device regulation / Barry Sall -- A primer of drug/device law : what is the law and how do I find it? / Josephine C. Babiarz -- The development of orphan drugs / Scott N. Freeman -- CMC sections of regulatory filings and CMC regulatory -- Compliance during investigational and postapproval stages / Prabu Nambiar, Steven R. Koepke, and Kevin Swiss -- Overview of the gxps for the regulatory professional / Bob Buckley, Robert Blanks, Kimberly J. White, and Tonya White-Salters -- FDA regulation of the advertising and promotion of prescription drugs, biologics, and medical devices / Karen L. Drake -- The practice of regulatory affairs / David S. Mantus -- FDA advisory / Christina A. McCarthy and David S. Mantus -- Biologics / Florence Kaltovich -- Regulation of combination products in the United States / John Barlow Weiner United States / Food and Drug Administration Drug Approval / United States United States Government Agencies / United States Biological Products / standards / United States Equipment and Supplies / standards / United States Government Regulation / United States MEDICAL / Pharmacology bisacsh Medizin Drug development USA Pisano, Douglas J. Sonstige oth Mantus, David Sonstige oth http://search.ebscohost.com/login.aspx?direct=true&scope=site&db=nlebk&db=nlabk&AN=686544 Aggregator Volltext |
| spellingShingle | FDA regulatory affairs United States / Food and Drug Administration Drug Approval / United States United States Government Agencies / United States Biological Products / standards / United States Equipment and Supplies / standards / United States Government Regulation / United States MEDICAL / Pharmacology bisacsh Medizin Drug development |
| title | FDA regulatory affairs |
| title_auth | FDA regulatory affairs |
| title_exact_search | FDA regulatory affairs |
| title_full | FDA regulatory affairs editors, Douglas J. Pisano, David Mantus |
| title_fullStr | FDA regulatory affairs editors, Douglas J. Pisano, David Mantus |
| title_full_unstemmed | FDA regulatory affairs editors, Douglas J. Pisano, David Mantus |
| title_short | FDA regulatory affairs |
| title_sort | fda regulatory affairs |
| topic | United States / Food and Drug Administration Drug Approval / United States United States Government Agencies / United States Biological Products / standards / United States Equipment and Supplies / standards / United States Government Regulation / United States MEDICAL / Pharmacology bisacsh Medizin Drug development |
| topic_facet | United States / Food and Drug Administration Drug Approval / United States United States Government Agencies / United States Biological Products / standards / United States Equipment and Supplies / standards / United States Government Regulation / United States MEDICAL / Pharmacology Medizin Drug development USA |
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