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 WebEx to free up travel time. WebEx is available to anyone with a UCSF.edu email account.

Consultations can be requested by completing the FDA Consultation Request.

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.

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