FDA Begins Product Approval Initiative

PsycEXTRA Dataset ◽

10.1037/e542762006-002 ◽

2003 ◽

Author(s):

Carol Lewis

Keyword(s):

Product Approval

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Inhaled Biologics: From Preclinical to Product Approval

Current Pharmaceutical Design ◽

10.2174/1381612822666160210142910 ◽

2016 ◽

Vol 22 (17) ◽

pp. 2501-2521 ◽

Author(s):

Kristin Fathe ◽

Silvia Ferrati ◽

Daniel Moraga-Espinoza ◽

Ashkan Yazdi ◽

Hugh D.C. Smyth

Keyword(s):

Product Approval

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Streamlining States’ Data Sharing for Advanced Onsite Product Approval: Using the Chesapeake Bay Watershed States as a Case Study for a Broader National Program

Proceedings of the Water Environment Federation ◽

10.2175/193864715819541701 ◽

2015 ◽

Vol 2015 (11) ◽

pp. 2954-2960

Author(s):

Maureen Pepper ◽

Joyce Hudson ◽

Mark Nelson ◽

Gemma Kite

Keyword(s):

Chesapeake Bay ◽

Data Sharing ◽

National Program ◽

Product Approval ◽

Chesapeake Bay Watershed ◽

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Product Approval and Public Health at the US Food and Drug Administration

JAMA ◽

10.1001/jama.2021.22354 ◽

2021 ◽

Author(s):

Peter Lurie ◽

Joshua M. Sharfstein

Keyword(s):

Public Health ◽

Drug Administration ◽

Food And Drug Administration ◽

Product Approval ◽

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Drug Product Approval in the United States and International Harmonization

Developing Solid Oral Dosage Forms ◽

10.1016/b978-0-12-802447-8.00038-8 ◽

2017 ◽

pp. 1049-1077

Author(s):

L. Wu ◽

H. Smith ◽

H. Zheng ◽

L.X. Yu

Keyword(s):

United States ◽

Drug Product ◽

The United States ◽

Product Approval ◽

International Harmonization

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Product Approval and Manufacturing Practices Related To Medical Devices

Journal of Biomaterials Applications ◽

10.1177/088532829100600209 ◽

1991 ◽

Vol 6 (2) ◽

pp. 184-184

Author(s):

R.J. Arnsberger ◽

D.A. Cutshall

Keyword(s):

Medical Devices ◽

Product Approval

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Regulatory Issues and Drug Product Approval for Biopharmaceuticals

Pharmaceutical Biotechnology ◽

10.3109/9781420044386-25 ◽

2007 ◽

pp. 447-453

Author(s):

Vinod Shah

Keyword(s):

Drug Product ◽

Regulatory Issues ◽

Product Approval

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Regulatory Requirements for Biological product approval process in India

Research Journal of Pharmacy and Technology ◽

10.5958/0974-360x.2020.00193.6 ◽

2020 ◽

Vol 13 (2) ◽

pp. 1050

Author(s):

C. Lokesh ◽

K. Sonia ◽

Raju Kamaraj

Keyword(s):

Approval Process ◽

Biological Product ◽

Regulatory Requirements ◽

Product Approval

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New Product Approval

Biomedical Safety & Standards ◽

10.1097/01.bmsas.0000305025.83169.78 ◽

2007 ◽

Vol 37 (22) ◽

pp. 176

Keyword(s):

New Product ◽

Product Approval

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New Biotechnology Product Approval

Biotechnology Law Report ◽

10.1089/blr.2012.9916 ◽

2012 ◽

Vol 31 (2) ◽

pp. 148-148

Keyword(s):

Product Approval ◽

Biotechnology Product

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The European Agency for the Evaluation of Medicinal Products’ Centralized Procedure for Product Approval: Current Status

Drug Information Journal ◽

10.1177/009286159903300401 ◽

1999 ◽

Vol 33 (4) ◽

pp. 969-978 ◽

Author(s):

Elaine M. Healy ◽

Kenneth I. Kaitin

Keyword(s):

Current Status ◽

Medicinal Products ◽

Product Approval ◽

European Agency

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