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.

Mr. Sanchez’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.

Mr. Sanchez 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.

Mr. Sanchez has submitted dozens of Pre-Market Tobacco Applications (PMTAs). He has advised manufacturers through the facility audits that occur during the Scientific Review phase of the PMTA process. He has also advised manufacturers on Deeming Regulations.

Mr. Sanchez has substantial experience with Emergency Use Authorization (EUA), and has worked extensively with the FDA for the approval of COVID-19 related therapeutics.

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

Mr. Sanchez’s 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

• Submitted PMTAs for over 40 companies to meet the September 2020 filing deadline (open and closed systems and e-liquid)
• Submitted PMTAs for over 20 companies to comply with the May 2022 synthetic nicotine deadline
• Regulatory submissions for moxifloxacin (application sought to add intracameral injections) and Terbinafine HCL cream and spray.
• 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