NDA/BLA/MAA Featured Articles

1. Speeding Research With Data Mining Expertise 4/26/2016

   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.

2. Considerations In Using Foreign Trial Data In U.S. NDA Submissions 8/3/2012

   More and more drug companies are finding it financially advantageous to conduct clinical trials in foreign countries and to include data from these trials in NDA submissions. When offshore trials are properly conducted and the data is properly handled, this strategy can accelerate approval and lower the cost of drug development. By Ken Phelps, Camargo Pharmaceutical Services

3. Expert Insight Into ePRO Industry Trends 6/7/2012

   As technologically savvy as we think we have become, there are still plenty of studies being conducted via pen and paper. By Rob Wright

4. A Chief Medical Officer's Perspective On Selecting A CRO 5/14/2012

   Santosh Vetticaden, Ph.D., M.D. is a drug development professional with over 20 years of experience spanning large pharma and biotech across multiple therapeutic areas. He has been involved in trials from Phase I-Phase IV and has been extensively involved in the design, planning, and implementation of global trials. By Rob Wright, Chief Editor, Life Science Leader magazine

5. Effective Medical Writing And Preparation For A Successful Clinical Submission 1/6/2012
   In 2007, the FDA released draft guidance to the industry pertaining to governance, compliance, safety, effectiveness, substantial and certifiable equivalence data included in clinical submissions. By Dr. Diane Mauriello Ph.D., Dante Resouces, Inc.
6. Post Market Reporting And The Use Of Terminologies: MedDRA And WHO-DD. 9/15/2011
   The pharmaceutical Industry is ever changing with novel drug development and research. The use of pharmaceutical products is carefully regulated from the initial submission of an Investigational New Drug application to the reporting of adverse events once the drug has been marketed. By Samina Qureshi, M.D., PSI International, Inc.