Brendan Carroll

• Assisting a medical device company develop a compliance plan and remediation strategy in response to Warning Letter. 
• Providing advice and counsel regarding pharmacy compounding issues at the state and federal level. 
• Evaluating the regulatory implications of health care-related software and software-related service offerings. 
• Providing advice regarding food additive petitions and food standards of identity. 
• Conducting review of food manufacturer’s labeling and advertising practices. 
• Representing a food manufacturer and retailer on compliance with and implementation of the requirements of the FDA Food Safety Modernization Act and menu labeling. 
• Developing regulatory comments on behalf of generic drug manufacturers. 
• Advocacy before Members of Congress and the executive branch on behalf of a wide range of small businesses.

Brendan Carroll is a senior associate on Alston & Bird's Food, Drug & Device/FDA Team. Brendan helps clients navigate complex FDA laws and regulations and counsels clients by assessing the regulatory risks in different phases of product development, marketing and advertising. He covers a wide range of FDA-regulated products including drugs, biologics, medical devices, tobacco, food, dietary supplements and cosmetics. He also focuses his practice on compliance and enforcement matters related to these FDA-regulated products, including Form FDA 483s and warning letters. In addition, Brendan assists clients in developing, designing and implementing legislative and regulatory strategies as an advocate before Members of Congress. Brendan received his J.D. from American University’s Washington College of Law in 2011, where he was a member of The American University Law Review. He received his B.A. from Princeton University, where he studied economics and politics.

Bar Admissions

• District of Columbia
• Maryland

Education

• American University (J.D., 2011)
• Princeton University (B.A., 2006)

Memberships