2017 New Drug Therapy Approvals

Introduction Promoting health through our new report, Innovation: Welcome to the advances of new drug approval in 2017 and other medication therapies. Since 2012, the FDA Drug Evaluation and Research Center (CDER) has announced a new drug summary report every year to explain the role of CDER in providing safe and effective innovative drug therapy to patients who need it Issuing. This year we expanded the scope of the report to provide more valuable information.

New drugs can represent important new treatments for advancing patient care. As you can see from this report, 2017 is no exception. However, there are more in the story. This year's report also emphasizes new approval for new drugs, but it provides important clinical progress and important medical value. Like other years, many important advances in 2017 are the approval of the use of FDA approved drugs for new purposes, or treatment of new patient groups such as children.

Our report also highlights many of the innovative regulatory tools CDER uses to increase efficiency and accelerate review and approval of drug treatments never sold in the United States. It is important to recognize that our decision on these approvals has been completed before and after the target date as defined in Congress and industry agreement (called user expense plan), most of which were approved before the United States is. Other countries of the world

CDER also contacts a pharmaceutical company to identify potential shortages of important medicines, deal with these deficiencies, make a quick review, utilize the discretion of law enforcement agencies, and strict hurricanes in 2017 It plays an active role in FDA's response to FDA. Medical need to reduce drug shortage

Importantly, without substantive support from a wide range of stakeholders in manufacturing, science, medical, and patient-centered organizations, CDER effectively evaluates the safety and efficacy of all these new drug therapies You can not. We will use this opportunity to emphasize that CDER leads or participates in many public-private partnerships and alliances to support innovation and improve medical care. The role of patients in the development and approval of pharmaceuticals is becoming increasingly important. Our report also shares some of the important advances that FDA has accomplished by incorporating patient perspective into decision making.

Our new report wishes that CDER will provide a deeper understanding of many ways to support innovation and improved patient care.

Santtu: Novartis and Kite Pharma are making headlines with gene therapy approved by the FDA. So, we are at the right place, especially in the media. There is little competition because target diseases are not lacking and each new drug needs to be customized according to the disease. The challenge is delivery, delivery and delivery to the market. Although this technology is powerful, it is mainly undeveloped. Jani: Finland's digital health care industry is strong by construction companies. After the collapse of Nokia, senior management began to establish its own company and was distracted from a lot of knowledge. What Finland is missing is a way to build a brand, work with companies, and understand the market strategy of the regulated environment in the US medical industry.

Introduction Promoting health through our new report, innovation: Welcome to the advances in 2017 new drug applications and other medications. Since 2012, the FDA Drug Evaluation Research Center (CDER) announces the outline of a new medicine magazine annually. This year we expanded the scope of the report to provide more valuable information. New drugs can represent new therapeutics that are important in advancing patient care. As you can see from this report, 2017 is no exception. However, there are more in the story. This year's report also emphasizes new approval for new drugs, but it provides important clinical progress and important medical value. Like other years, many important advances in 2017 are the approval of the use of FDA approved drugs for new purposes, or treatment of new patient groups such as children.