NDA/BLA/MAA Featured Articles

  1. 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

  2. Efficient Contracting Processes For Clinical Trials ... From The Legal Perspective 1/27/2012

    On Dec. 1, 2011 in Cambridge, MA, law firm Pepper Hamilton’s Timothy Atkins, partner, life sciences, and Jason Reiser, associate, life sciences, gave a presentation as part of the firm’s Life Sciences Speaker Series. By Sara Gambrill

  3. 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    In 2007, the FDA released draft guidance to the industry pertaining to governance, compliance, safety, effectiveness, substantial and certifiable equivalence data included in clinical submissions.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.
  4. Bringing A Billion-Dollar Drug To Market 1/4/2012

    A report by Deloitte on the world’s 12 largest drugmakers shows that the average cost of bringing a product to market rose by more than 25% to greater than $1B in 2011, from $830M in 2010. By Cindy Dubin

  5. 5 Key Questions & Answers Regarding Pharmacovigilance 9/29/2011

    A Q&A with Sanket Agrawal, executive director, global regulatory affairs and safety, at Amgen, and Nagaraja Srivatsan, senior VP, head of life sciences, North America, Cognizant Technology Solutions.

  6. C-Path And The Predictive Safety Testing Consortium: Working To Qualify Safety Biomarkers For Preclinical Use 9/29/2011

    Safety liabilities are a major cause of attrition during drug development. Adverse drug reactions resulting in post-approval withdrawal of a medicine cost the pharmaceutical industry millions of dollars and affect thousands of people every year. By Mark Camercon

  7. 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.