Laura Heller

Laura Heller supports clients in navigating the regulatory strategy and FDA policy environment.

  Trained as a biochemist, she applies her background in pharmaceutical development to support a broad range of clients by translating technical information and providing in-depth clinical knowledge. 

Prior to joining Avalere, Laura held a postdoctoral position researching infectious diseases at Georgetown University Medical Center where she gained significant experience in drug development. She also served as a part-time consultant for a start-up company, VitamInfuse, where she offered scientific guidance for the creation of new IV therapy products. Laura's interests include projects related to gene therapy, oncology, rare disease, and drug and device regulatory policy. 

Laura has a PhD in chemistry from Georgetown University and a BA in chemistry and art history from Franklin & Marshall College.

Authored Content

On October 24, the FDA released a draft guidance describing the intended risk-based approach for regulatory actions toward homeopathic drug products marketed in the United States without the required FDA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.