Loading…

Development of FDA-regulated medical products : a translational approach /

Show other versions (1)

Bibliographic Details
Call Number:	Libro Electrónico
Main Author:	Whitmore, Elaine (Author)
Format:	Electronic eBook
Language:	Inglés
Published:	Milwaukee, Wisconsin : ASQ Quality Press, 2012.
Edition:	Second edition.
Subjects:	United States. > Food and Drug Administration. United States. > Food and Drug Administration Drug approval > United States. Biological products > Standards > United States. Medical instruments and apparatus > Standards > United States. Biologicals. Biological products. Biological Products Biological Factors United States Government Agencies > United States. Translational Medical Research > United States. Government Regulation > United States. Drug and Narcotic Control > legislation & jurisprudence > United States. Biological Products > United States. Device Approval > legislation & jurisprudence > United States. Drug Approval > legislation & jurisprudence > United States. Drug and Narcotic Control > legislation & jurisprudence Device Approval > legislation & jurisprudence Drug Approval > legislation & jurisprudence Government Regulation Translational Research, Biomedical United States Government Agencies Médicaments > Autorisation de mise sur le marché > États-Unis. Produits biologiques > Normes > États-Unis. Produits biologiques. Médicaments biologiques. MEDICAL > Pharmacology. Biological products > Standards Drug approval Medical instruments and apparatus > Standards United States
Online Access:	Texto completo

Similar Items

Development of FDA-regulated medical products : a translational approach /
by: Whitmore, Elaine
Published: (2012)

Development and approval of combination products : a regulatory perspective /
Published: (2008)

Medical devices and the public's health : the FDA 510(k) clearance process at 35 years /
Published: (2011)

Development and approval of combination products a regulatory perspective /
Published: (2008)

Public health effectiveness of the FDA 510(k) clearance process : measuring postmarket performance and other select topics : workshop report /
Published: (2011)

Public health effectiveness of the FDA 510(k) clearance process : measuring postmarket performance and other select topics : workshop report /
Published: (2011)

To America's health : a proposal to reform the Food and Drug Administration /
by: Miller, Henry I.
Published: (2000)

Public health effectiveness of the FDA 510(k) clearance process : balancing patient safety and innovation : workshop report /
Published: (2010)

The FDA and worldwide quality system requirements guidebook for medical devices /
by: Daniel, Amiram
Published: (2008)

Safe and effective medicines for children : studies conducted under the Best Pharmaceuticals for Children Act and the Pediatric Research Equity Act /
Published: (2012)

Considerations for ensuring safety and efficacy of vaccines and therapeutic proteins manufactured by using platform approaches : summary of a workshop /
Published: (2010)

Considerations for ensuring safety and efficacy of vaccines and therapeutic proteins manufactured by using platform approaches : summary of a workshop /
Published: (2010)

The FDA and worldwide quality system requirements guidebook for medical devices /
by: Daniel, Amiram
Published: (2008)

Compassionate use and emergency use authorization for unapproved drugs : FDA policies and background /
Published: (2016)

FDA's drug review process and the package label : strategies for writing successful FDA submissions /
by: Brody, Tom
Published: (2017)

International regulatory harmonization amid globalization of drug development : workshop summary /
by: Weisfeld, Victoria D., et al.
Published: (2013)

Challenges for the FDA : the Future of Drug Safety : Workshop Summary /
Published: (2007)

Ethical and scientific issues in studying the safety of approved drugs /
Published: (2012)

Drugs : from discovery to approval /
by: Ng, Rick
Published: (2015)

Medical device design and regulation /
by: DeMarco, Carl T.
Published: (2011)

Medical device design and regulation /
by: DeMarco, Carl T.
Published: (2011)

Medical device regulations : global overview and guiding principles.
by: Cheng, Michael
Published: (2003)

Making better drugs for children with cancer /
Published: (2005)

Making better drugs for children with cancer /
Published: (2005)

Pharmaceutical lifecycle management : making the most of each and every brand /
by: Ellery, Tony
Published: (2012)

The textbook of pharmaceutical medicine /
Published: (2013)

Building a national framework for the establishment of regulatory science for drug development : workshop summary /
Published: (2011)

WHO Expert Committee on Biological Standardization.
by: Organization, World Health
Published: (2013)

The future of drug safety : promoting and protecting the health of the public /
Published: (2007)

WHO Expert Committee on Biological Standardization.
by: Organization, World Health
Published: (2007)

WHO Expert Committee on Biological Standardization : fifty-fourth report.
by: Organization, World Health
Published: (2005)

WHO Expert Committee on Biological Standardization : fifty-second report.
Published: (2004)

WHO Expert Committee on Biological Standardization : sixtieth report /
Published: (2013)

Intelligent drug development : trials and errors in clinical research /
by: Tansey, Michael
Published: (2014)

Intelligent drug development : trials and errors in clinical research /
by: Tansey, Michael
Published: (2014)

Who Expert Committee on Biological Standardization : sixty-second report.
Published: (2013)

Nonclinical Safety Assessment : a Guide to International Pharmaceutical Regulations.
by: Brock, William
Published: (2013)

Drug and device product liability litigation strategy /
by: Herrmann, Mark
Published: (2012)

Strategy and science at the FDA : plans, goals and challenges for the future /
Published: (2012)

How to develop and implement a national drug policy.
Published: (2001)

Cannot write session to /tmp/vufind_sessions/sess_rfh3ncbe22d8agen8h00g50mil