Regulations and Procedures for New Drug Evaluation and Approval in China

2006 ◽  
Vol 17 (10) ◽  
pp. 970-974 ◽  
Author(s):  
Hongzhang Yin
Keyword(s):  
Drug Evaluation ◽  
New Drug

scholarly journals Guidelines on New Drug Evaluation

1999 ◽  
Vol 4 (9) ◽  
pp. 68-70
Author(s):  
Shigeru Kageyama
Keyword(s):  
Drug Evaluation ◽  
New Drug

Etablishing rhesus model of pulmonary fibrosis (PF) for the new drug evaluation

2015 ◽  
Author(s):  
Lian Liu ◽  
Hao Wang ◽  
Hao Wang ◽  
Xiaoou Li ◽  
Fuqiang Wen
Keyword(s):  
Pulmonary Fibrosis ◽  
Drug Evaluation ◽  
New Drug

Investigational New Drug applications: a 1-year pilot study on rates and reasons for clinical hold

2016 ◽  
Vol 64 (2) ◽  
pp. 376-382 ◽  
Author(s):  
Larissa Lapteva ◽  
Anne R Pariser
Keyword(s):  
Retrospective Study ◽  
Pilot Study ◽  
Drug Product ◽  
Drug Evaluation ◽  
Fiscal Year ◽  
First Year ◽  
Common Disease ◽  
Investigational Product ◽  
New Drug ◽  
Clinical Hold

BackgroundThe Food and Drug Administration (FDA)'s Center for Drug Evaluation and Research (CDER) receives about 1500 initial Investigational New Drug applications (INDs) per year. In the first 30 days after initial IND submission, FDA conducts a review to determine whether the proposed investigation is safe to proceed, and if not, the IND may be placed on clinical hold.MethodsA retrospective study of rates and reasons for clinical hold for all initial INDs submitted to CDER in fiscal year (FY) 2013 was performed. INDs were assessed for reasons that led to clinical hold, included chemistry, manufacturing and controls (CMC), animal toxicology or clinical issues. INDs were further categorized by commercial versus research sponsorship, and rare versus common disease indications. All INDs placed on hold were reassessed by whether they remained on hold within the first year following hold imposition.ResultsCDER received 1410 initial INDs in FY 2013, of which 125 (8.9%) were placed on hold during the first 30 days after initial submission. Of the INDs placed on hold, more than half became active within the first year after first imposition of hold. CMC reasons were most commonly cited, followed by clinical, then toxicology reasons. There were no substantive differences in rates and reasons for hold between INDs for rare or common disease indications, or between commercial or research INDs.ConclusionsThe vast majority of initial INDs moved forward within 30 days after submission, and for those applications placed on hold, most became active within 1 year. The findings also suggest that many holds for new drug product programs can be avoided by following the available guidelines for investigational product development.

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