Vision DMD: Vamorolone drug development program for Duchenne muscular dystrophy

2016 ◽  
Vol 26 ◽  
pp. S156
Author(s):  
M. Guglieri ◽  
P. Clemens ◽  
A. Cnaan ◽  
J. Damsker ◽  
H. Gordish-Dressman ◽  
...  
Keyword(s):  
Duchenne Muscular Dystrophy ◽  
Muscular Dystrophy ◽  
Drug Development ◽  
Development Program ◽  
Drug Development Program

Vision DMD: A drug development program for vamorolone in Duchenne muscular dystrophy

2017 ◽  
Vol 27 ◽  
pp. S17
Author(s):  
M. Guglieri ◽  
P. Clemens ◽  
A. Cnaan ◽  
J. Damsker ◽  
H. Gordish-Dressman ◽  
...  
Keyword(s):  
Duchenne Muscular Dystrophy ◽  
Muscular Dystrophy ◽  
Drug Development ◽  
Development Program ◽  
Drug Development Program

Vision DMD: Vamorolone (VBP15) drug development program for Duchenne muscular dystrophy

2017 ◽  
Vol 21 ◽  
pp. e238
Author(s):  
M. Guglieri ◽  
P. Clemens ◽  
A. Cnaan ◽  
J. Damsker ◽  
A. Arrieta ◽  
...  
Keyword(s):  
Duchenne Muscular Dystrophy ◽  
Muscular Dystrophy ◽  
Drug Development ◽  
Development Program ◽  
Drug Development Program

Duchenne muscular dystrophy: Drug development and regulatory considerations

2010 ◽  
Vol 41 (6) ◽  
pp. 740-745 ◽  
Author(s):  
D. Elizabeth McNeil ◽  
Carole Davis ◽  
Devanand Jillapalli ◽  
Shari Targum ◽  
Anthony Durmowicz ◽  
...  
Keyword(s):  
Duchenne Muscular Dystrophy ◽  
Muscular Dystrophy ◽  
Drug Development

scholarly journals FDA relations during drug development

2000 ◽  
Vol 2 (3) ◽  
pp. 213-217
Keyword(s):  
Drug Development ◽  
Drug Application ◽  
Development Program ◽  
The United States ◽  
Legal Aspects ◽  
Development Programs ◽  
New Drug ◽  
Regulatory Affairs ◽  
New Drug Application ◽  
Drug Development Program

Working closely and cooperatively with regulatory authorities during drug development is vital to successful drug development programs. In the United States, the drug development team includes not only members of the key disciplines of drug discovery, clinical research, regulatory affairs, marketing, chemistry, toxicology, and legal aspects, but also the Food and Drug Administration (FDA). New regulations encourage meetings at the pre-investigational new drug (pre-IND), end-of-phase-2, and pre-new drug application (pre-NDA) submission phases. Appropriate informal discussions via fax and telephone are also encouraged. By proactively interacting with the FDA, the pharmaceutical industry increases the probability of a successful drug development program.

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