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 →
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 →
As the Trump transition team forms its plans for taking the reins in January, Catalyst applauds FasterCures for issuing a set of recommendations intended to inform the new Administration’s approach… read more →
Nancy Bradish Myers, President Today the FDA granted its first-ever approval for a Duchenne Muscular Dystrophy (DMD) treatment; Sarepta received Accelerated Approval for its drug Exondys 51 (eteplirsen) to treat… read more →
It’s been eight years since the FDA Science Board released its “FDA Science and Mission at Risk” report; that report painted a stark picture of FDA’s capabilities, in particular its… read more →