Brandy Guarda is a regulatory analyst supporting the FDA + Healthcare Regulatory and Compliance practice in Morrison Foerster’s Washington, D.C. office. Brandy predominantly focuses on researching and tracking FDA and interagency regulatory guidance, proposed and final rules, legislation, and enforcement actions.

Brandy provides clients with insights on the developing regulatory and policy landscape for FDA-regulated products, tracks Anti-Kickback Statute and other fraud and abuse developments, and tracks healthcare policy and legislative developments, including the Inflation Reduction Act.

Brandy has extensive experience and can offer specialized assistance in FDA and healthcare matters. Her qualifications and skills are described in more detail below.

Dietary Supplements/Food

• Certified in regulatory compliance for dietary supplements and natural health products, including 21 C.F.R. 111 (Current Good Manufacturing Practice in Manufacturing, Packaging, Labeling, or Holding Operations for Dietary Supplements).

• Certified to evaluate evidence used in claims substantiation.

• Supports clients by tracking and monitoring FDA regulatory and enforcement actions on unapproved, adulterated, or misbranded dietary supplements and food, including baby food and infant formula.

• Tracks regulatory and legislative developments impacting the sale and marketing of dietary supplements, including state initiatives.

Pharmaceutical & OTC Drugs

• Reviews and analyzes advertising and promotional claims, including for unapproved uses.

• Supports clients by tracking and monitoring FDA regulatory and enforcement actions on unapproved, adulterated, or misbranded drugs, including OTC and homeopathic drugs.

• Supports clients by tracking and monitoring OTC monographs.

• Provides research and analysis on drug approval precedents, including under the 505(b)(1) and 505(b)(2) pathways, Orange Book listings, and expedited review programs.

Medical Devices

• Reviews and analyzes advertising and promotional claims, including for unauthorized uses.

• Supports clients by tracking and monitoring FDA regulatory and enforcement actions on unapproved, adulterated, or misbranded medical devices.

• Analyzes Software as a Medical Device (SaMD), Digital Health Technologies (DHTs), and Laboratory Developed Tests (LDTs), including precedent and policies.

• Analyzes publicly available data on precedents, adverse events, and competitor products.

Cosmetics

• Reviews and analyzes advertising and promotional claims.

• Supports clients by tracking and monitoring FDA regulatory and enforcement actions on unapproved, adulterated, or misbranded cosmetics.

• Tracks implementation of the Modernization of Cosmetics Regulation Act (MoCRA).

Certificate Courses

• Regulatory Affairs Professionals Society® (Regulation of Dietary Supplements and NHPs)

• EAS Consulting Group (Dietary Supplement Good Manufacturing Practices)

• EAS Consulting Group (Dietary Supplements Claims Substantiation)

Prior to joining MoFo, Brandy supported two other FDA and healthcare legal practices. Brandy’s work focused heavily on inspection preparations, DOJ investigations, regulatory inquiries, FDA submissions, and summarizing legislative updates from congressional hearings.