scholarly journals Aggregation and analysis of secondary pharmacology data from investigational new drug submissions at the US Food and Drug Administration

Author(s):  
Andrew Dodson ◽  
Kevin Mi ◽  
Daniel P. Russo ◽  
Christina Scott ◽  
Muriel Saulnier ◽  
...  
2021 ◽  
Vol 14 (2) ◽  
pp. 145
Author(s):  
Othman Al Musaimi ◽  
Danah Al Shaer ◽  
Fernando Albericio ◽  
Beatriz de la Torre

2020 has been an extremely difficult and challenging year as a result of the coronavirus disease 2019 (COVID-19) pandemic and one in which most efforts have been channeled into tackling the global health crisis. The US Food and Drug Administration (FDA) has approved 53 new drug entities, six of which fall in the peptides and oligonucleotides (TIDES) category. The number of authorizations for these kinds of drugs has been similar to that of previous years, thereby reflecting the consolidation of the TIDES market. Here, the TIDES approved in 2020 are analyzed in terms of chemical structure, medical target, mode of action, and adverse effects.


2006 ◽  
Vol 2 (1) ◽  
pp. 173-186 ◽  
Author(s):  
Robert S. Kern ◽  
Michael F. Green ◽  
Stephen R. Marder

ABSTRACTA key obstacle to the development of new drugs to treat the cognitive deficits of schizophrenia was the absence of a standard by which to measure their efficacy. Before granting approval for any new drug for this condition, the US Food and Drug Administration wanted a standard cognitive endpoint based on a broad consensus-based method. To address this obstacle, the Measurement and Treatment Research to Improve Cognition in Schizophrenia (MATRICS) intiative oversaw a process to develop a consensus neurocognitive battery. Its development included a ten-step process that is described in this article.


2019 ◽  
Vol 179 (8) ◽  
pp. 1144
Author(s):  
Harinder Singh Chahal ◽  
David Szeto ◽  
Anam H. Chaudhry ◽  
Daniel W. Sigelman ◽  
Stella Kim ◽  
...  

2013 ◽  
Vol 18 (1) ◽  
pp. 14-38 ◽  
Author(s):  
Rebecca F. Chhim ◽  
Chasity M. Shelton ◽  
Michael L. Christensen

The objective of this 2-part review is to provide information about drugs that have been recently approved by the US Food and Drug Administration. Part 1 reviewed recently approved drugs with pediatric indications. Part 2 reviews drugs recently approved only in adults and have published or ongoing studies in children.


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