Adele M Gilpin

Research and development matters and FDA compliance matters in pharmaceutical, medical devices, and biologics. GxP; clinical trials related matters; research contracting; investigator initiated studies; IND and NDA matters; DEA matters; HIPAA; human subjects protections; IRB matters; research misconduct investigations and proceedings; study design; intended use, indications, and claims; trade complaints; regulatory pathway for devices and combination products; trade complaints

Medical devices and pharmaceutical industry research and development: GCP, clinical trials, SOPs, research and services contracts, preapproval and preclearance matters, IND, 510k, PMA, NDA, trade complaints; stem cell regulation matters.

Represent or advise biomedical researchers related to allegations of research misconduct or departure from GCP; defend researchers in IRB actions to terminate projects and subsequent retraction of notification to FDA; assist research institutions in conducting DHHS Part 93 research misconduct inquiries; conduct internal investigations; as coordinating center academic researcher, also conducted fraud detection and investigation activities. 8 years legal, 13 years research based.