By Nancy Bradish Myers, Anne McNickle and Jill Hartzler Warner In the past week, we’ve seen significant advances in the gene therapy world. Within the span of two days, Gilead… read more →
By Nancy Bradish Myers At the DIA annual meeting earlier this month, I had the privilege of exploring key regulatory issues related to CRISPR, as moderator of a session entitled… read more →
By Nancy Bradish Myers The DIA annual meeting session “Regulatory Frameworks: How Can Regulators Facilitate Disruptive Innovation?” earlier this month offered a rare window into companies that are developing cutting… read more →
FDA is receiving “encouragement” from many directions right now to promote drug competition. Here’s what companies need to know. The current political climate is an interesting one; FDA is receiving… read more →
On June 13, Catalyst President Nancy Bradish Myers will present on PDUFA and other user fee agreements, and their impact on drug competition. Ms. Myers will be a featured speaker… read more →
Given rapid advances in technology and our understanding of disease, the future will bring a shift in how the health care system thinks about and uses data, Michael Doherty, Foundation… read more →
Press release Washington, DC – Catalyst Healthcare Consulting is pleased to announce that Jill Hartzler Warner, JD, has joined the firm as Vice President, Regulatory Policy. She will advise clients… read more →
By Nancy Bradish Myers and Anne Petruska McNickle On Jan. 30, President Trump issued what is now known as the “2-for-1” (or 2:1) executive order, directing federal agencies that promulgate any new… read more →
Pharmaceutical Online- What do President Trump’s deregulatory executive orders mean for the industry? In this article in Pharmaceutical Online, Catalyst’s Nancy Bradish Myers and Anne Petruska McNickle explore Trump’s “2-for-1”… read more →
This month, President Obama signed the 21st Century Cures bill into law. At nearly 1,000 pages, Cures is full of new requirements for FDA. As I see it, some of… read more →