Regulatory Support (FDA)

 

Regulatory Support personnel provide free consultations to the UCSF community, with particular focus on compliance with Food and Drug Administration (FDA) regulations.   If you have questions about an Investigational New Drug (IND) application, an Investigational Device Exemption (IDE), FDA inspections, ClinicalTrials.gov records, or other related topics, please reach out to us.

Our office is located at the Laurel Heights campus. While we welcome in-person meetings at Laurel Heights, we conduct most consultations via zoom to free up travel time. 

Consultations can be requested by submitting a FDA Consultation Request form.

Alternatively, you may send your FDA related question to [email protected].

For additional FDA resources, visit the HUB.

Contacts

Melanie Hassel, MS, Regulatory Specialist, Office of Ethics and Compliance
415.502.3212

Melanie joined the Office of Ethics and Compliance in October 2016 as a Regulatory Specialist, with a focus on FDA regulations. She came from UC Berkeley after 8 years in various regulatory roles. Her regulatory experience spans Human Subjects Research Protection, Whistleblower, Privacy/HIPAA, California Public Records Act, FERPA, and Title IX.

Ruby Warnock, MPH, Regulatory Support Analyst, Office of Ethics and Compliance

Ruby joined the Office of Ethics and Compliance in March 2020 as a Regulatory Support Analyst supporting researchers with ClinicalTrials.gov compliance requirements. She has a background in research administration and regulatory support and has been working at UCSF since 2015.

Backup for FDA matters: Joan Doherty Campbell, JD, Associate Director, Office of Ethics and Compliance
415.502.2792

For ClinicalTrials.gov user accounts and questions, please email Ruby Warnock and Melanie Hassel at [email protected].