- Advising and counseling foreign and domestic manufacturing facilities regarding FDA inspections, regulatory meetings, warning letters, import alerts, and consent decrees. This work has included extended on-site support in India, Central Europe, and China.
- Assisted with the submission of an Investigational New Drug (IND) application on behalf of the developer of a SARS-CoV-2 vaccine. Alston & Bird’s work included a protocol review, as well as advice regarding the delivery system for the vaccine and assistance addressing FDA questions regarding the application.
- Advising numerous companies regarding blood plasma products and related regulatory and health and safety concerns.
- Advising foreign and domestic pharmaceutical manufacturers on the implications of FDA inspection delays as a result of the coronavirus.
- Advising commercial manufacturers seeking to develop diagnostic test kits and personal protective equipment for health care workers.
- Served as the defense team’s first chair for expert testimony on CGMPs and analytical method validation in United States v. Barr Laboratories, widely recognized as the leading case on CGMPs.
- Advising and counseling domestic and foreign pharmaceutical manufacturers on issues related to data integrity.
- Negotiated the successful resolution of import alerts and warning letters related to CGMPs, data integrity, and inspection refusal.
- Defended a targeted medical device executive in a criminal referral.
- Negotiated an FDA consent decree in a case involving the mass seizure of a generic drug company’s inventory.
- Developed medical device company compliance plans and remediation strategies in response to recidivist warning letters.
- Provided advice and counsel on drug and medical device regulation, as well as development of preparedness strategies and crisis communications, related to the SARS and H1N1 influenza pandemics.
- Provided advice and counsel regarding FDA Emergency Use Authorizations.
- Counseled on a wide range of regulatory compliance matters affecting blood banks.
- Counseled on pharmacy compounding and outsourcing facility issues.
- Preparing clients for FDA inspections.
- Counseled on supply chain management.
Partner,
- Phone: 202.239.3648
- Email: cathy.burgess@alston.com
FDA-regulated entities benefit from Cathy’s common-sense advice for achieving business objectives that avoid compliance and enforcement risks. With more than 25 years of extensive experience in the areas of CGMP regulation and product risk management, she provides strategic counseling and works with clients to identify and address potential risks throughout the product life cycle.