spacer
home > ict > summer 2019 > expert tips for a successful application
PUBLICATIONS
International Clinical Trials

Expert Tips for a Successful Application



The commercialisation of a new drug in the US follows a rigid path. Each step along the process, from R&D to labelling and final release on the market, is strictly monitored by the FDA. However, applying for FDA approval for a new drug can be a real minefield.

According to a recent study from the Massachusetts Institute of Technology, only about 14% of all drugs in clinical trials gain approval from the FDA, the US federal agency responsible for protecting and promoting public health. This means that for 86% of all proposed new drugs, something goes wrong along the process towards commercialisation − wasting time, energy, and capital. So, what are the most common avoidable mistakes when applying for FDA approval, and what can applicants do to prevent them from occurring?

Read full article from PDF >>

Rate this article You must be a member of the site to make a vote.  
Average rating:
0
     

There are no comments in regards to this article.

spacer
About the author


Dr Harneet Arora is a Physical Therapist and Clinical Scientist with over five years of clinical research experience in neuromuscular diseases, orthopedics, and neurology, and over seven years of experience in research data collection, designing, managing, and communicating the results of clinical research studies.


Print this page
Send to a friend
Privacy statement
News and Press Releases

MedPharm’s CSO and University of Reading Professor co-author new book on dermal formulation development

MedPharm’s Chief Scientific Officer and Co-Founder, Professor Marc Brown and University of Reading’s Professor Adrian Williams have co-authored the new book: ‘The Art and Science of Dermal Formulation Development”. It is the latest addition to ‘Drugs and the Pharmaceutical Sciences’, a series of textbooks and monographs published by CRC Press.
More info >>

White Papers

Managing GxP Environmental Systems to Ensure Data Integrity

Vaisala Ltd


More info >>

 
Industry Events

SCOPE Summit for Clinical Ops Executives

18-21 February 2020, Hyatt Regency, Orlando, Florida, US

Celebrating its 11th successful year, SCOPE Summit 2020 takes place February 18-21 in Orlando, FL. Over the course of four stimulating days of in-depth discussions in 20 different conferences, 3 plenary keynote sessions, the annual Participant Engagement Awards, and the ever-popular interactive breakout discussions, the programming focuses on advances and innovative solutions in all aspects of clinical trial planning, management and operations
More info >>

 

 

©2000-2011 Samedan Ltd.
Add to favourites

Print this page

Send to a friend
Privacy statement