David Elder brings more than 36 years of extensive regulatory experience to his role at ELIQUENT Life Sciences. A 23-year veteran of the U.S. Food and Drug Administration (FDA) and U.S. Public Health Service (USPHS), David served as a senior executive in FDA with prominent roles in domestic and foreign inspections, recalls and emergencies, and compliance actions involving hundreds of situations. He has testified in federal court and before Congress, conducted inspections and investigations, initiated and approved enforcement actions, and represented the FDA during national media events.

David began his FDA career as an Investigator in the Boston District Office where he conducted domestic and foreign inspections and investigations in pharmaceutical, medical device, and biologics program areas. He was selected as a Compliance Officer and later as the Director of the Compliance Branch with responsibility for assessment of inspection reports and evidence, initiation of compliance actions, and evaluation of compliance action effectiveness.

David transferred to FDA headquarters when he was selected as the Director of the FDA Office of Enforcement in 2003, a position he held for the next six years. In this Senior Executive Service (SES) position, David led the Office with responsibility for agency compliance and enforcement policy, health fraud investigations, guidance and regulation review, agency recall policy and operations, and enforcement strategy and case review. In 2009, David transferred from the Office of Enforcement to the Office of Regional Operations where he led the Office with responsibility for policy and operations related to foreign inspections, domestic inspections, emergency response investigations, import operations, and field regulatory science operations.

Prior to joining ELIQUENT Life Sciences, David served as Vice President with PAREXEL International. He traveled to client locations worldwide to conduct audits and mock inspections; provide training, coaching, and mentoring; and advise clients on the development and communication of corrective actions that meet FDA expectations and that achieve and sustain compliance.

At ELIQUENT, David continues to provide strategic guidance and support to pharmaceutical and medical technology companies in areas including: strengthening corporate quality systems; developing compliance strategies; supporting inspections and ensuring inspection readiness; assisting industry clients and legal counsel in developing and communicating corrective action plans in response to compliance issues; verifying completed corrective actions; executive training and coaching; and performing due diligence. In both consulting positions since leaving FDA, David traveled to client sites across the U.S. and in 16 foreign countries. He continues to communicate expert advice through presentations at FDA and industry conferences, articles published in industry journals, and in FDLI’s 2022 book, How FDA Really Works: Insights from the Experts.