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FDAnews Webinar: On Challenges Facing the New FDA Commissioner

January 21st, 2022|Comments Off on FDAnews Webinar: On Challenges Facing the New FDA Commissioner

During her panel for FDAnews, Nancy Myers highlighted impending challenges looming over FDA’s commissioner hopeful, Robert Califf. If confirmed, Califf would enter the FDA at a time crucial to rebuilding public trust in the Agency [...]

Accelerated Approval Standards: Application to Gene Therapy

September 25th, 2021|Comments Off on Accelerated Approval Standards: Application to Gene Therapy

At the ASGCT Policy Summit 2021, Nancy Bradish Myers shared these slides to help participants understand FDA’s accelerated approval standards and how they specifically apply to gene therapies.  In addition, she highlighted the ongoing debate [...]

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Ruling Blocks Okla. MCO Program, But Fight May Not Be Over

June 25th, 2021|Comments Off on Ruling Blocks Okla. MCO Program, But Fight May Not Be Over

AISHealth.com — June 25, 2021 Jeff Myers, Catalyst’s Senior Vice President, Market Access & Reimbursement Strategies, discusses the legal technicalities which tripped up Oklahoma as the health providers win their lawsuit against Republican Gov. Kevin [...]

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Marks Took On FDA Vaccine Leadership Position What Happens Now?

November 1st, 2021|Comments Off on 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) and identifies cautionary [...]

RWE at the Tipping Point: From Registries to Artificial Intelligence, RWE is Poised to Accelerate Medical Product Development

May 24th, 2018|Comments Off on 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 that have traditionally [...]

Artificial Intelligence (AI): Coming to a Policymaker Near You

April 2nd, 2018|Comments Off on 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 and harness the [...]