Blog Archive
Expected FDA Impact of a Government Shutdown
Critically, the critical public health mission and user fees are the buffer for FDA when a shutdown occurs. Below, we will delve into how a shutdown may look for the FDA under [...]
Government Shutdown 101: What to Expect
March 14th is approaching fast, and it increasingly looks like politicians are driving us toward another government shutdown. Budgeting Basics. The federal government is currently operating under a continuing resolution (CR) passed [...]
Catalyst advances women’s health in new LinkedIn article
On Tuesday, Catalyst's Taryn Serman and Nancy Myers, together with industry leaders, published the following article regarding women's health on LinkedIn. A Case for Going Beyond Just Talking About Advancing Women's Health: [...]
The Catalyst Team shows support on Rare Disease Day
Being rare is often a blessing: a rare gem stands out from a pile of stones, a rare talent can garner prestige and success, and a rare personality can make for an [...]
The launch of a patient-focused nonprofit: Catalyst Healthcare Consulting lends a hand
Two integral parts of Catalyst’s corporate mission are to 1) surf ahead of regulatory trends and anticipate environmental needs and 2) be good and do good. In the spirit of these objectives, [...]
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, [...]
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 [...]
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 [...]
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 [...]
FDA User Fee Programs Reauthorized: FDA’s CBER Is A Clear Winner
Pharmaceutical Online/Cell & Gene/Bioprocess Online – October 6, 2022 PDUFA VII, CBER and the new gene & cell therapy Super Office: Catalyst’s Nancy Bradish Myers shares her insights on the cleanest user [...]
Marks Took On FDA Vaccine Leadership Position What Happens Now?
Outsourced PharmaOnline / PharmaceutialOnline — November, 1 2021 Nancy Bradish Myers shares views on Dr Peter Marks’ decision to step into an Acting Director role at the CBER Office of Vaccines (OVRR) [...]
RWE at the Tipping Point: From Registries to Artificial Intelligence, RWE is Poised to Accelerate Medical Product Development
By Anne McNickle This is an exciting time for those of us interested in RWE development. Digital technologies and advanced computing capabilities are enabling the generation of RWE continuously, and from sources [...]
Artificial Intelligence (AI): Coming to a Policymaker Near You
By Nancy Bradish Myers It’s as if Artificial Intelligence just reached the DC area and policy makers need to think about it. Software companies, academic institutions and innovative companies hoping to develop [...]
Digital Health: New Law Encourages Telehealth Services For Medicare Patients
By Nancy Bradish Myers As Congress moved to keep the doors open for the federal government, it also swept in changes to advance the use of telemedicine for Medicare patients. These are [...]
Digital Medicine is Here: Why the Combination of Abilify and Proteus’ Ingestible Sensor is “Sweet”!
By Nancy Bradish Myers Yahooooo! What a thrill it is to finally have the first digital medicine approved by the FDA: Abilify Mycite (aripiprazole + Ingestible Event Marker). When I visualize it, [...]
Gene Therapy Milestones: Gilead’s Acquisition of Kite Pharma and FDA’s Novartis CAR-T Approval Signal an Advancing Gene Therapy Field; What Are Key Takeaways for Gene Therapy Companies?
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 announced it [...]
CRISPR Technology: Experts Explore Key Opportunities and Challenges in Catalyst-Moderated Panel
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 “CRISPR: Regulatory [...]
Disruptive Technology: How Can Regulators Facilitate Innovation?
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 edge technologies [...]
Promoting Drug Competition: What Both Innovator and Generic Companies Need to Know About FDA’s Emerging Competition Agenda
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 pressure from [...]
Trump’s Deregulatory Agenda – Implications for Biopharma & Medtech Companies
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 [...]
Now that Cures is Law, What Do Biopharma Companies Need to Know?
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 the key [...]
Catalyst Commends FasterCures for Highlighting FDA Resource Needs
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 to biomedical [...]
Megaphone Moment: FDA uses Exondys 51 Accelerated Approval to Prove Regulatory Flexibility and Value of Patient Engagement
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 a subset [...]
Progress Report – No “Hogtying” Here: Science Board Soon To Release Report Indicating “Science and Mission” No Longer “At Risk,” But Improvements Still Needed To Facilitate Medical Product Innovation
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 inability to [...]
Patients Front and Center: Expanding Opportunities for the Patient Voice to be Heard
It is all about the patient. Thank goodness the whole health ecosystem is being reminded of this and is redoubling its efforts to put the patient in the center of drug development [...]
Breakthrough Therapy: FDA Highlights Lessons Learned During First Two-and-a-Half Years
Quality of Data is Key, and the Bar is Always Moving for Innovators By: Nancy Bradish Myers, President, Catalyst Healthcare Consulting, Inc. Twitter: FDAInsightGuru FDA started implementing the Breakthrough Therapy Designation (BTD) [...]
FDA Uses Brookings Event to Clarify the Breakthrough Designation Pathway
Goal is to Make the Process More Efficient and Save FDA Time and Resources By: Nancy Bradish Myers, President, Catalyst Healthcare Consulting, Inc. Twitter: FDAInsightGuru Prior to passage of the Food and [...]