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FDA Safety and Innovation Act: A Step Forward for Patients With Rare Diseases

By Peter L. Saltonstall, President and CEO, National Organization for Rare Disorders (NORD) The Food …

Biosimilars Ahead, Proceed with Caution

By Richard M. Dolinar, M.D., Chairman, Alliance for Safe Biologic Medicines In today’s budget-constrained world, …

Industry Regulatory Issues to be Highlighted at 2012 BIO International Convention

In the words of BIO’s Andrew Emmett, Managing Director, Science & Regulatory Affairs, ‘2012 is …

What Parallel Review Means for Manufacturers

By Stephen Rothenberg, J.D. and Matt Levy, J.D., Numerof & Associates, Inc. (NAI) Currently, the …

Managing in a Cost-Constrained Environment

By Jill E. Sackman, D.V.M., Ph.D., Senior Consultant, and Matt Levy, J.D., Business Analyst, at …

Reviewing the drug class of 2011

The drug class of 2011 was larger than the past few graduating classes. We count …

Let's Get PDUFA V Approved, Fast

By Marc Boutin, JD, Executive Vice President and Chief Operating Officer, National Health Council At …

2012: A Critical Year for Biotechnology

In 2012, we must continue to look for ways to reduce risk; enhance reward; reduce …

The Ethics of Global Clinical Trials

By Dr. Russell Medford, Salutria Pharmaceuticals Recent reports have raised concerns about how clinical trials are …

CHI Offering Free Webinar on FDA Draft Guidances

The California Healthcare Institute will be hosting a free online discussion on Tuesday, October 25, 2011 that …