Latest Blog Entries

crispr4

June 27, 2017

CRISPR Technology: Experts Explore Key Opportunities and Challenges in Catalyst-Moderated Panel

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By Nancy Bradish Myers At the DIA annual meeting earlier this month, I had the privilege of exploring key regulatory... Read More →
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June 25, 2017

Disruptive Technology: How Can Regulators Facilitate Innovation?

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By Nancy Bradish Myers The DIA annual meeting session “Regulatory Frameworks: How Can Regulators Facilitate Disruptive Innovation?” earlier this month... Read More →
promoting-drug-comp

June 14, 2017

Promoting Drug Competition: What Both Innovator and Generic Companies Need to Know About FDA’s Emerging Competition Agenda

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FDA is receiving “encouragement” from many directions right now to promote drug competition. Here’s what companies need to know. The... Read More →
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April 21, 2017

Trump’s Deregulatory Agenda – Implications for Biopharma & Medtech Companies

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By Nancy Bradish Myers and Anne Petruska McNickle On Jan. 30, President Trump issued what is now known as the “2-for-1” (or... Read More →
21cc

December 22, 2016

Now that Cures is Law, What Do Biopharma Companies Need to Know?

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This month, President Obama signed the 21st Century Cures bill into law. At nearly 1,000 pages, Cures is full of... Read More →
cat-cd2

November 14, 2016

Catalyst Commends FasterCures for Highlighting FDA Resource Needs

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As the Trump transition team forms its plans for taking the reins in January, Catalyst applauds FasterCures for issuing a... Read More →
megaphone

September 19, 2016

Megaphone Moment: FDA uses Exondys 51 Accelerated Approval to Prove Regulatory Flexibility and Value of Patient Engagement

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Nancy Bradish Myers, President Today the FDA granted its first-ever approval for a Duchenne Muscular Dystrophy (DMD) treatment; Sarepta received... Read More →
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September 15, 2015
Doctor and patient

July 29, 2015

Patients Front and Center: Expanding Opportunities for the Patient Voice to be Heard

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It is all about the patient. Thank goodness the whole health ecosystem is being reminded of this and is redoubling... Read More →
Vials in a centerfuge

May 4, 2015

Breakthrough Therapy: FDA Highlights Lessons Learned During First Two-and-a-Half Years

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Quality of Data is Key, and the Bar is Always Moving for Innovators By: Nancy Bradish Myers, President, Catalyst Healthcare... Read More →
lab-tech-with-tubes2

May 3, 2015

FDA Uses Brookings Event to Clarify the Breakthrough Designation Pathway

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Goal is to Make the Process More Efficient and Save FDA Time and Resources By: Nancy Bradish Myers, President, Catalyst... Read More →
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