Literature DB >> 25713472

FDA's Expedited Approval Mechanisms for New Drug Products.

Erin E Kepplinger.   

Abstract

Year:  2015        PMID： 25713472      PMCID： PMC4326266          DOI： 10.1089/blr.2015.9999

Source DB:  PubMed          Journal:  Biotechnol Law Rep        ISSN： 0730-031X            Impact factor:   0.146


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  14 in total

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2.  The Prescription Drug User Fee Act: Much More Than User Fees.

Authors:  Aaron P Mitchell; Niti U Trivedi; Peter B Bach
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Authors:  Maya A Farha; Eric D Brown
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5.  The endless frontier? The recent increase of R&D productivity in pharmaceuticals.

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Journal:  J Transl Med       Date:  2020-04-09       Impact factor: 5.531

6.  Survival Analysis in Patients with Metastatic Merkel Cell Carcinoma Treated with Avelumab.

Authors:  Tereza Lanitis; Irina Proskorovsky; Apoorva Ambavane; Matthias Hunger; Ying Zheng; Murtuza Bharmal; Hemant Phatak
Journal:  Adv Ther       Date:  2019-07-26       Impact factor: 3.845

7.  Regulatory approval for COVID-19 across the globe.

Authors:  Vidya Mahalmani; T Pugazhenthan; Niti Mittal; Shoban Babu Varthya; Bikash Medhi
Journal:  Indian J Pharmacol       Date:  2020 Nov-Dec       Impact factor: 1.200

Review 8.  Factors that influence clinical efficacy of live biotherapeutic products.

Authors:  Bruno Pot; Yvan Vandenplas
Journal:  Eur J Med Res       Date:  2021-05-04       Impact factor: 2.175

Review 9.  Regulatory perspectives of combination products.

Authors:  Jiaxin Tian; Xu Song; Yongqing Wang; Maobo Cheng; Shuang Lu; Wei Xu; Guobiao Gao; Lei Sun; Zhonglan Tang; Minghui Wang; Xingdong Zhang
Journal:  Bioact Mater       Date:  2021-09-07

10.  Trends in FDA drug approvals over last 2 decades: An observational study.

Authors:  Angelika Batta; Bhupinder Singh Kalra; Raj Khirasaria
Journal:  J Family Med Prim Care       Date:  2020-01-28
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