home > ict > summer 2019 > expert tips for a successful application
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:

There are no comments in regards to this article.

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

Merck to Provide BioReliance® End-to-End Solutions to Phanes Therapeutics

• Collaboration to accelerate development and manufacturing of Bispecific Antibody • Merck plans to offer Phanes a full suite of products and services under its BioReliance® offering
More info >>

White Papers

galenIQ - The smart excipient


galenIQ combines a multitude of outstanding characteristics and is suitable for a wide range of pharmaceutical applications. galenIQ can be used as more than just a bulk excipient. It also serves as an anti-caking agent, anti-humectant agent, stabilizer or oral care and taste agent to mention just a few additional functions.
More info >>

Industry Events

ESMO Targeted Anticancer Therapies Congress 2020

2-4 March 2020, Paris, France

A unique and international mix of experts, researchers and decision makers both from academia and industry across the globe, will convene in Paris for a three-day Congress aiming at exchanging knowledge, experience and research innovations in cancer. TAT 2020 will focus, among others, on novel strategies in immuno-oncology, personalised medicine and molecular tumour boards, preclinical studies to identify effective combination therapies, use of microbiome, tumour agnostic trials, ADC technology, oncolytics, multispecific biological constructs and targeting cytokines. Participating in TAT 2020 will offer you the possibility to take part in interdisciplinary discussions inspiring new ideas and new collaborations.
More info >>



©2000-2011 Samedan Ltd.
Add to favourites

Print this page

Send to a friend
Privacy statement