Volume 6 Issue 9 - 2018
New Drug Approvals by FDA from 2013-2017
Varun Ahuja*
Drug Safety Assessment, Novel Drug Discovery and Development, Lupin Limited (Research Park), Pune, India
*Corresponding Author: Varun Ahuja, Drug Safety Assessment, Novel Drug Discovery and Development, Lupin Limited (Research Park), Pune, India.
Received: July 18, 2018; Published: August 01, 2018
Citation: Varun Ahuja. “New Drug Approvals by FDA from 2013-2017”. EC Pharmacology and Toxicology 6.9 (2018): 772-774.
The pharmaceutical sector is a very challenging industry. It involves huge investments, strong regulations, and low output in terms of new drugs. Bringing a drug into the market is an arduous task, and involved testing from preclinical safety to clinical trials. With its understanding of the science used to create new products, testing and manufacturing procedures, and the diseases and conditions that new products are designed to treat, FDA (U.S. Food and Drug Administration) provides scientific and regulatory advice needed to bring new therapies to market.
Drug products include both small molecules and biological products. Approval of new molecular entities (NMEs) is authorized under Part 314 (Title 21, Chapter 1, Subchapter D, Part 314, subpart B) of the Electronic Code of Federal Regulations and approval of biological products is authorized under Part 601 (Title 21, Chapter 1, Subchapter F, Part 601, subpart C) of the Electronic Code of Federal Regulations [1,2]. For simplicity, the term “drugs” will be used to refer to both new molecular entities and biological products in this manuscript. Novel drugs can represent important new therapies for advancing patient care. During past five years (2013 - 2017), the U.S.
Copyright: © 2018 Varun Ahuja. This is an open-access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited.

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