Patrick Crowley

• Counseling  foreign and domestic clients on compliance with Current Good Manufacturing Practices (CGMPs), FDA facility inspections, responses to FDA Form 483 observations and warning letters, and product recalls.
• Counseling clients on submissions to the FDA under the Generic Drug User Fee Amendments (GDUFA).
• Preparing clients for FDA meetings, including regulatory meetings and post-warning letter meetings.
• Providing regulatory diligence and strategic guidance in complex life sciences transactions, including mergers and acquisitions.
• Advising on regulatory disclosures and securities filings for pharmaceutical companies.

Patrick Crowley  provides guidance to clients on FDA regulatory and compliance matters.

Before joining Alston & Bird, Patrick worked for the Department of Health and Human Services, Office of the General Counsel and the District of Columbia Department of Health, Office of the General Counsel.

While at the American University Washington College of Law, Patrick was president of the Moot Court Honor Society and a staff member for the Administrative Law Review.

Bar Admissions

• District of Columbia

Education

• American University (J.D., 2024)
• University of Texas at San Antonio (B.A., 2021)