Marc Sanchez specializes in advising foreign and domestic healthcare clients and is highly experienced in matters involving the Food, Drug, and Cosmetic Act and related laws.

Marc’s clients include those from the pharmaceutical and medical device industry, as well as those from the food and beverages, and cosmetics industry. Marc is also well versed in regulatory requirements concerning Laboratory Developed Tests (LDTs), including CLIA waivers, and has advised clients navigate regulatory pathways for approval of in vitro diagnostics kits.

He provides counseling on pre-market strategies including product development, clinical investigations, orphan drug and other designations, premarket applications (e.g., NDAs, 505(b)(2)s, ANDAs, 501(k), and 513(g) submissions), controlled correspondence, dispute resolution and appeals, label negotiations, monograph reviews, GRAS petitions, marketing and classification review for human and animal products, and other pre-marketing matters.

On post-marketing strategies, Marc provides counseling on labeling, advertising and promotion, product recalls, good manufacturing practices (GMPs), and responding to agency enforcement actions.

His work also involves the United States Department of Agriculture where he handles matters encompassing drugs, biologics, and medical foods. Marc is specially well-versed in food and drug enforcement actions including OTC Drug Listings, Color Additive Certifications, and Food Contact Substance Petitions.

Representative Matters

⦁ Pre-submission and classification of an LDT used for breast cancer screening
⦁ CLIA waiver review for Genevolve Vision Diagnostics congenital color blindness diagnostic LDT
⦁ Classification and pre-market submission for IVD related to cranial CSF
⦁ Application of Practice of Medicine Doctrine for Physicians 360’s at home LDTs

Recent Notable Publications

⦁ Author, “Food Law and Regulations for Non-Lawyers: A US Perspective, Springer International”. A US Perspective, December 2014