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Califf: FDA will be a ‘more activist’ agency
Regulatory Focus - Aug. 24, 2023 Note: This article describes an interview co-moderated by Catalyst CEO Nancy Myers, along with Tom Kraus, VP- Government Relations, American Society for Health-System Pharmacists. The webinar interview was sponsored by [...]
Telework helps FDA compete for scientists. What if it’s no longer an option?
STAT+ May 11, 2023 Catalyst CEO and Founder Nancy Bradish Myers provided her perspective on FDA hybrid/telework policies and the impact of any potential changes in the future. With over 2,000 vacancies at the agency, [...]
HHS Floats Trio of Drug Pricing Models, Some More Ambitious Than Others
AISHealth.com - February 23, 2023 Jeff Myers, Catalyst’s Senior Vice President, Market Access & Reimbursement Strategies, comments on the pricing models recently announced by CMS. Mr. Myers "says cell and gene therapy manufacturers may be skeptical [...]
Former FDA Chief Counsel Elizabeth Dickinson Hailed For Her Expertise, Warmth and Mentorship
The Pink Sheet - September 27, 2022 In an article on the legacy of retiring FDA Chief Counsel/Deputy Chief Counsel Elizabeth Dickinson, Catalyst’s Nancy Bradish Myers comments that Dickinson’s management style won her internal accolades. [...]
Latest Blog Posts and Op Eds
FDA Office of the Ombudsman: Focusing on Communication and Ensuring All Voices Are Heard
During an interview with the Alliance for a Stronger FDA on Aug. 30, 2023, Laurie Lenkel, JD, Director, FDA Office of the Ombudsman, provided an overview of the functions of the office, how it interacts [...]
Rare Disease Week: Marking the 40th anniversary of the Orphan Drug Act
By Anne McNickle, VP - Research & Communications, Catalyst Can you believe 2023 is the 40th anniversary of the Orphan Drug Act (ODA)? That is some time lapse! In this blog, we want to highlight [...]
CMS sends roses to Sickle Cell Patients; but will the rest of Cell and Gene Therapy get the thorns?
By Jeff Myers, Senior Vice President, Reimbursement Strategy and Market Access, Catalyst. On February 14th, CMS released its answer to President Biden’s Executive Order to “do something” to lower drug prices in the public payor programs. [...]
Catalyst’s Nancy Myers Co-Moderates Alliance for a Stronger FDA Webinar Featuring FDA Deputy Commissioner Andi Fristedt
Catalyst's Nancy Myers participated in an Alliance for a Stronger FDA webinar with FDA's Deputy Commissioner for Policy, Legislation & International Affairs Andi Fristedt on Jan. 13. Ms. Myers co-moderated the session with Emily Holubowich, [...]