A pragmatic regulatory approach for complex generics through the U.S. FDA 505(j) or 505(b)(2) approval pathways-Reference-Cited by-同舟云学术

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A pragmatic regulatory approach for complex generics through the U.S. FDA 505(j) or 505(b)(2) approval pathways

Published:2021-07-22 Issue:1 Volume:1502 Page:5-13
ISSN:0077-8923
Container-title:Annals of the New York Academy of Sciences
language:en
Short-container-title:Ann. N.Y. Acad. Sci.

Author:

Klein Kevin¹,Borchard Gerrit²,Shah Vinod P.³,Flühmann Beat⁴,McNeil Scott E.⁵,Vlieger Jon S. B.¹

Affiliation:

1. Foundation Lygature Utrecht the Netherlands

2. Institute of Pharmaceutical Sciences of Western Switzerland (ISPSO) University of Geneva Geneva Switzerland

3. VPS Consulting LLC North Potomac Maryland

4. Vifor Pharma Ltd. Glattbrugg Switzerland

5. Department of Pharmaceutical Sciences University of Basel Basel Switzerland

Publisher

Wiley

Subject

History and Philosophy of Science,General Biochemistry, Genetics and Molecular Biology,General Neuroscience

Link

https://onlinelibrary.wiley.com/doi/pdf/10.1111/nyas.14662

Reference37 articles.

1. Nanomedicine: Principles, Properties, and Regulatory Issues

2. Delivering the power of nanomedicine to patients today

3. Sizing up the Next Generation of Nanomedicines

4. Characterization of nanomedicines: A reflection on a field under construction needed for clinical translation success

5. Advances in oligonucleotide drug delivery

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4. Nanosimilars: A Scientific or A Regulatory Debate?;The AAPS Journal;2024-07-02

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