If you are considering whether to take the time in advance of your investigational new drug (IND) application submission to meet with FDA for feedback on your development program, here are some thoughts to ponder and reasons not to pass up this valuable opportunity.
According to The STM Report (2015), more than 2.5 million peer-reviewed articles are published in scholarly journals each year. PubMed alone contains more than 25 million citations for biomedical journal articles from MEDLINE. The amount and availability of content for clinical researchers has never been greater – but finding the right articles to use is becoming more difficult.
The primary challenge for pharmaceutical and biotechnology companies in developing their drugs is to carefully assess the relationship between efficacy and toxicity prior to entering into human clinical trials. By Dr. Scott E. Boley and Greg Ruppert
Biopharmaceutical companies’ marketing applications must present the history of their unique development programs and provide renewed hope for patients seeking safe and effective therapies. PRA Health Sciences has the necessary experience to deliver comprehensive marketing applications (NDA, BLA, MAA, etc) across all therapeutic areas and in all regions.
The EU Clinical Trials Directive (CTD) has been fully implemented in the Netherlands.
An international pharmaceutical company approached Camargo Pharmaceutical Services to help navigate the Food and Drug Administration (FDA) 505(b)(2) approval pathway for a promising drug under development designated for patients with cardiovascular disease. Product X is a prodrug that is converted in one metabolism-dependent step to produce the active metabolite of an approved drug.