David Barr

Mr. Barr served with the FDA for 20 years before joining AAC in October 1994. In his present position as Vice President, Regulatory Compliance Consulting, he is responsible for the Drug and Device work performed by AAC Senior Consultants. This work includes providing advice concerning compliance with US Food, Drug and Cosmetic Act and regulations: developing training programs designed to enhance knowledge of regulations and quality assurance principles; conducting audits for cGMPs, QSRs, clinical regulatory compliance and 21 CFR Part 11; evaluating strategies for product approval; reviewing the CMC portion of pharmaceutical applications; writing and reviewing 510ks; and providing services as an expert witness.

Previously, Mr. Barr served as the Deputy Director of the FDA’s Office of Compliance – Center for Drug Evaluation and Research (CDER). As Chief of CDER’s Office of Compliance’s Policy and Guidance Branch in the Division of Manufacturing and Product Quality, he worked on the development of Agency policy and guidance documents regarding pharmaceutical manufacturing, including revisions to the CGMPs, compliance review of foreign firms, and communications with the inspectorates of other countries. Mr. Barr came to CDER from the FDA Chicago District where he served as a Supervisory Investigator responsible for Pharmaceutical and Device inspections.