News Archive 2018-01-29T19:45:18+00:00

FDA Nominee Driven by “Data, Data, Data”

September 23rd, 2015|

Genetic Engineering News – FDA Commissioner-nominee Califf brings “clinical trial experience, a deep understanding of the scientific standards industry is held to, and a healthy appreciation for innovation,” Catalyst President Nancy Bradish [...]

FDA Deputy Califf’s New Role

February 2nd, 2015|

In an article on the challenges and opportunities Robert Califf faces as the newly appointed FDA Deputy Commissioner for Medical Products and Tobacco, Catalyst President Nancy Bradish Myers provides perspective on the [...]

FDLI Update magazine

June 1st, 2013|

This issue of the FDLI Update highlights a panel discussion on FDA and "Interagency Dynamics" at FDLI's annual meeting. The article notes that the panel, moderated by Catalyst President Nancy Bradish Myers, [...]

Did PDUFA V Pass Too Quickly?

June 25th, 2012|

This article notes the swift completion of negotiations between House and Senate staff on PDUFA V (the FDA Safety & Innovation Act), and asks whether the bill could have been improved with [...]

FDA and User Fees: Time to Give 100%

April 11th, 2011|

The article highlights comments made by authors who contributed to the book recently co-edited by the Catalyst team and published by the Food and Drug Law Institute (see release, below, on PDUFA [...]

FDA Week

April 7th, 2011|

CDER Director Janet Woodcock comments on FDA experience with user fees during Food and Drug Law Institute panel moderated by Catalyst's Nancy Myers "Woodcock Expresses Concern With Too Much Reliance On User [...]

Fall 2010 issue

September 30th, 2010|

Biotechnology Healthcare "Oncology Biomarker Diagnostics: Where We Are, Where We Need To Be" This wide-ranging article examines the reasons behind the relatively low number of commercialized diagnostic products in oncology. Catalyst President [...]

Catalyst President and Alliance for a Stronger FDA Vice President Nancy Bradish Myers comments on FDA’s new accountability initiative, “FDA TRACK.” Click below to view the Alliance for a Stronger FDA press release, issued April 7, 2010:

May 10th, 2010|

Alliance for a Stronger FDA Applauds FDA’s New Accountability Initiative “This is a bold but needed undertaking as FDA works to regain public confidence and respect,” Ms. Myers said. “Over the next [...]