Kelly L. George

Kelly George supports clients in navigating the regulatory strategy and FDA policy environment for products in the space of drugs, biologics, and medical devices.

Trained as a peptide chemist, she provides in-depth technical knowledge to guide clients by translating technical information into clear strategic policy responses.

Prior to joining Avalere, Kelly focused on pipeline technologies in pre-FDA approval phases of development at the Innovation Institute. Prior to that, she worked as a scientific consultant with Fourth River Solutions where she focused on business strategy development and in-depth market analysis on medical devices.

Kelly has a PhD in peptide chemistry from the University of Pittsburgh and a BS in biology from James Madison University.

Authored Content

On Monday, March 23, over 90 products that had historically been regulated as drugs were deemed to be licensed as a biologic. This includes insulin products. During the past several years, the Food & Drug Administration (FDA) has released guidance about their interpretation of the provision to guide sponsors and provide information about what to expect for the transition.

Opportunities exist to accelerate potential vaccine development.

As the Coronavirus Disease 2019 (COVID-19), caused by the novel SARS-CoV-2 virus, rapidly spreads through the US, media and public scrutiny over the current diagnostic testing landscape has increased, given that the US lags behind other countries in the number of tests performed and turnaround time for results reported.

On October 24, the FDA released a draft guidance describing the intended risk-based approach for regulatory actions toward homeopathic drug products marketed in the United States without the required FDA approval. The FDA has not approved a single homeopathic product thus far. The agency is currently restructuring its enforcement and regulatory priorities in this space.

The Food and Drug Administration’s (FDA) efforts to modernize medical device oversight in the agency’s Center for Devices and Radiological Health (CDRH) have continued with the release of multiple draft and final guidances in 2019, as well as a plan for additional releases in 2020.

A new FDA resource is available to identify drug candidates for additional study and serve as a resource to shape medical decisions.

Patient access to high-quality, low-cost generic drugs continues to increase, due to a record number of generic approvals by the FDA in fiscal year 2019.

On August 6, Avalere’s regulatory experts published an article in BioDrugs highlighting upcoming regulatory changes for insulin.