Tag Archives: Food and Drug Administration

What Parallel Review Means for Manufacturers

Drug Manufacturing

By Stephen Rothenberg, J.D. and Matt Levy, J.D., Numerof & Associates, Inc. (NAI) Currently, the FDA and CMS consider new medical products in series; after FDA approval or clearance, CMS begins consideration of a National Coverage Determination (NCD), if requested by an interested stakeholder. Any party seeking drug approval (e.g., manufacturers, suppliers, providers, medical professional organizations, and Medicare beneficiaries) may initiate a request for an NCD. In addition, CMS may initiate a request for an Read More >

Health  |  Leave a comment  |  Email This Post
Tags: , , , ,

Managing in a Cost-Constrained Environment

medicine-thumb

By Jill E. Sackman, D.V.M., Ph.D., Senior Consultant, and Matt Levy, J.D., Business Analyst, at Numerof & Associates, Inc. (NAI) The pharmaceutical industry has entered a critical period of transition. Business models that have proven remarkably successful over the past 20 years are now encountering major challenges. As biotech companies grapple with the leading symptoms of these challenges – pricing pressures, pipeline productivity concerns, a growing public distrust, and greater political and regulatory scrutiny – Read More >

Business of Biotech  |  1 Comment  |  Email This Post
Tags: , , , , ,

Let’s Get PDUFA V Approved, Fast

Marc Boutin

By Marc Boutin, JD, Executive Vice President and Chief Operating Officer, National Health Council At this time of the year, it can be helpful to reflect on the past to guide us in the future. I was recently reading an editorial about the National Health Council (NHC) printed in January 1957 – 37 years after the organization’s creation. It spoke about the need for action with “an unprecedented degree of cooperation among health agencies and Read More >

Health  |  Leave a comment  |  Email This Post
Tags: , , , , , , ,

2012: A Critical Year for Biotechnology

Capitol

In 2012, we must continue to look for ways to reduce risk; enhance reward; reduce uncertainty; and reinforce the position of the industry as a major contributor resolving society’s most pressing needs. Policies to encourage investment in innovation and to speed discovery to scientific breakthroughs simply must be the priority in 2012. The industry relies on a policy and regulatory environment that encourages innovation for much needed treatments and cures for some of the most Read More >

Public Policy  |  1 Comment  |  Email This Post
Tags: , , , , , ,

The Ethics of Global Clinical Trials

Dr. Russell Medford

By Dr. Russell Medford, Salutria Pharmaceuticals Recent reports have raised concerns about how clinical trials are being performed in other countries, particularly in the developing world. Even prior to these reports, some have asserted that sponsors conduct clinical trials abroad to avoid red tape and avoid overly stringent and time consuming regulatory processes. However, research done by companies with the intent of seeking FDA approval and access to the U.S. market must still meet FDA standards Read More >

Health  |  2 Comments  |  Email This Post
Tags: , , , , , ,