A. Chamblee, Esq., RAC, F*RAPS
About Me
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Ms. Chamblee is a regulatory affairs (RA) expert and inducted into the first class of RA Fellows.  She has over twenty years of experience developing, communicating, and implementing regulatory and compliance initiatives.  Her FDA experience includes working as an ombudsman and liaison for FDA.  Her experience in regulatory affairs is in analyzing and articulating strategies with manufacturers, as well as Agency experts and customers.  She has extensive experience resolving disputes with FDA.

In her last position with FDA, she worked in the Commissioner's Office as a liaison with entrepreneurs, pharmaceutical and BioTech companies, medical manufacturers, and practitioners and patients. She spoke before trade and professional groups on subjects that included the agency’s desire for feedback on draft programs, the rationale for FDA initiatives. This includes combination products, inspections, user fees, and the role of the new ombudsman office. She also coordinated review of complex regulatory efforts and compliance initiatives. For manufacturers with approval slowdowns at the Agency, she assured any hurdles to success were identified and addressed.

Ms. Chamblee is trained as an FDA application reviewer and establishment inspector.

Ms. Chamblee has written numerous articles for publication on combination product regulation, FDA Reform, including on product promotion under the FDA Reform law, and on the affect of tobacco regulation on other regulated products.

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To contact, send e-mail to achambleee@yahoo.com

Ms. Chamblee spent all but the first 2 years of her life in Maryland, and graduated the University of Maryland College Park with honors and a Scholarship Certificate from the Arts & Humanities Division in 1983.  She graduated the University of Maryland at Baltimore Law School in 1986, participating in the Moot Court Board. 

marathon.jpg
Andrea steps deliberately on the Finish Line

Emotional Finish

In 2001, Andrea completed the 26.2 mile Marine Corps Marathon in Washington, DC.  The route included passing the Pentagon damaged by after 9/11/01.  The Pentagon attack killed 189 people: 125 in the Pentagon and 64 aboard American Airlines, including Lisa Raines, 42, of Genzyme Corporation. Ms. Raines was a pasenger on AA flight 77.