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Published October 7, 2014
Will continue to pursue FDA approval of daclatasvir Read More »
Ensuring Drug Quality in a Global Economy
By Helena Champion , Principal Consultant, Drug Quality Assurance LLC
Published May 1, 2014
Offshore CMO’s have proven a weak link in pharma’s supply chain. Will recent quality problems in India and China increase oversight? Read More »
New Rules on Medicinal Product Clinical Trials in Europe
By Genevieve Michaux, Hunton & Williams LLP
Published March 7, 2014
In April 2014, the European Parliament and European Council will officially adopt a new regulation on clinical trials of medicinal products (the Regulation). The Regulation is expected to take effect in May 2016 and will replace Directive 2001/20/EC,… Read More »
Published March 25, 2013
A filing with the FDA to gain approval of a major change that has a substantial potential to have an adverse effect on the identity, strength, quality, purity, or potency of a drug product as these factors may relate to the safety or effectiveness of… Read More »
Implementing Process Validation Guidances
By Peter H. Calcott, Ph.D., President, Calcott Consulting LLC
Published March 6, 2013
Complying with FDA and EU for small and mid-sized companies Read More »
By Colleen Heisey, J.D., MPH, Hunton & Williams LLP
Published March 6, 2013
Enrichment strategies for clinical trials supporting product approval Read More »
Export Controls and the Biotech Industry
By Eric McClafferty and Brooke Ringel, Kelley Drye & Warren LLP
Published May 4, 2012
Are you in compliance? Read More »
By Colleen Heisey, J.D.
Published October 8, 2010
CMC postapproval manufacturing changes reportable in annual reports Read More »
IT Focus: Computer System Validation
By Michael J. Gregor
Published March 3, 2010
Prepare your systems for FDA inspection Read More »
By Kevin O'Donnell
Published July 18, 2008
Storage vs. shipping and the vagaries of regulatory requirements Read More »
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