alexa Stem Cells To The Market Place
ISSN: 2157-7552

Journal of Tissue Science & Engineering
Open Access

Like us on:
OMICS International organises 3000+ Global Conferenceseries Events every year across USA, Europe & Asia with support from 1000 more scientific Societies and Publishes 700+ Open Access Journals which contains over 50000 eminent personalities, reputed scientists as editorial board members.

Open Access Journals gaining more Readers and Citations

700 Journals and 15,000,000 Readers Each Journal is getting 25,000+ Readers

This Readership is 10 times more when compared to other Subscription Journals (Source: Google Analytics)

Share This Page

Additional Info

Loading
Loading Please wait..
 

2nd International Conference on Tissue Science & Regenerative Medicine
August 26-28, 2013 DoubleTree by Hilton, Raleigh, NC, USA

Karl M. Nobert
ScientificTracks Abstracts: J Tissue Sci Eng
DOI: 10.4172/2157-7552.S1.010
Abstract
S tem Cells intended for use in humans are regulated under the U.S. Food and Drug Administration?s regulations governing human cells, tissues, cellular and tissue based products (HCT/Ps). Depending upon such use and their functional impact within the body however, they may also be subject to FDA?s drug, biologic or medical devices rules. This presentation will provide an overview of FDA?s legal authority and regulation governing stem cells products, the criteria that the FDA uses to determine a product?s regulatory status, and offer strategies for mitigating the potential risks associated with the marketing and selling a stem cell product in the U.S. Relying on recent FDA warning letters and court cases, the presenter will identify specific regulatory risks relevant to cellular products and therapies; and discuss methods for controlling such risks
Biography
Karl M. Nobert is a Food and Drug Regulatory Attorney with Squire Sanders (U.S.) LLP in Washington, DC. His legal practice focuses on the U.S. Food and Drug Administration?s regulation of prescription and over-the-counter drug products, biologics including cellular and tissue products; medical devices and veterinary products. He has considerable experience working with clients on the design and adoption of FDA regulatory strategies covering the manufacturing, marketing and sale of both human and veterinary regenerative products. He frequently writes and presents on these topics.
image PDF   |   image HTML
 

Relevant Topics

Peer Reviewed Journals
 
Make the best use of Scientific Research and information from our 700 + peer reviewed, Open Access Journals
International Conferences 2017-18
 
Meet Inspiring Speakers and Experts at our 3000+ Global Annual Meetings

Contact Us

Agri & Aquaculture Journals

Dr. Krish

[email protected]

1-702-714-7001Extn: 9040

Biochemistry Journals

Datta A

[email protected]

1-702-714-7001Extn: 9037

Business & Management Journals

Ronald

[email protected]

1-702-714-7001Extn: 9042

Chemistry Journals

Gabriel Shaw

[email protected]

1-702-714-7001Extn: 9040

Clinical Journals

Datta A

[email protected]

1-702-714-7001Extn: 9037

Engineering Journals

James Franklin

[email protected]

1-702-714-7001Extn: 9042

Food & Nutrition Journals

Katie Wilson

[email protected]

1-702-714-7001Extn: 9042

General Science

Andrea Jason

[email protected]

1-702-714-7001Extn: 9043

Genetics & Molecular Biology Journals

Anna Melissa

[email protected]

1-702-714-7001Extn: 9006

Immunology & Microbiology Journals

David Gorantl

[email protected]

1-702-714-7001Extn: 9014

Materials Science Journals

Rachle Green

[email protected]

1-702-714-7001Extn: 9039

Nursing & Health Care Journals

Stephanie Skinner

[email protected]

1-702-714-7001Extn: 9039

Medical Journals

Nimmi Anna

[email protected]

1-702-714-7001Extn: 9038

Neuroscience & Psychology Journals

Nathan T

[email protected]

1-702-714-7001Extn: 9041

Pharmaceutical Sciences Journals

Ann Jose

[email protected]

1-702-714-7001Extn: 9007

Social & Political Science Journals

Steve Harry

[email protected]

1-702-714-7001Extn: 9042

 
© 2008- 2017 OMICS International - Open Access Publisher. Best viewed in Mozilla Firefox | Google Chrome | Above IE 7.0 version
adwords