About
Carlo focuses on U.S. Food and Drug Administration (FDA) regulatory considerations in life sciences transactions. He advises clients in evaluating product regulatory pathways, and identifying, assessing, and mitigating enforcement risks. Carlo has extensive experience conducting FDA due diligence, as well as drafting key regulatory language in public company disclosures and agreements.
Carlo has deep substantive knowledge of the regulatory processes and complex requirements under the Federal Food, Drug, and Cosmetic Act and FDA regulations. He routinely advises clients across the product lifecycle, including clinical and preclinical development, manufacture, marketing, and distribution of regulated products. He also has expertise in premarket authorization pathways, recalls, reporting requirements, and advertising and promotion. Carlo’s experience spans pharmaceuticals, biological products, medical devices, digital health, diagnostics, and biological products.
Prior to joining Freshfields, Carlo was a member of the FDA and Health Care practice of another global law firm.
Carlo regularly advises clients from an FDA regulatory perspective in transactional matters involving life sciences companies, including:
- Platinum Equity in its acquisition of Owens & Minor’s Products & Healthcare Services segment*
- J.P. Morgan on its participation as lead investor in the Series C financing round for Olipop*
- BioCryst Pharmaceuticals on $400 million debt financing for acquisition of Astria Therapeutics*
- US WorldMeds on its acquisition of Adaptimmune Therapeutics’ TECELRA, lete-cel, afami-cel, and uza-cel cell therapies*
- Natera, Inc., on its acquisition of Foresight Diagnostics*
- Merck on its acquisition of EyeBio*
- Arrowhead Pharmaceuticals on its $500 million strategic financing facility with Sixth Street*
- Bora Pharmaceuticals on its acquisition of Upsher-Smith Laboratories*
- United Therapeutics on its acquisition of Miromatrix Medical*
- Crown Bioscience on its acquisition of Indivumed’s contract research organization (CRO) business unit*
- Aprea Therapeutics in its initial public offering*
- Centrient Pharmaceuticals in its acquisition of pharmaceutical manufacturer Astral SteriTech Privated Limited*
- Tempest Therapeutics on its merger with Millendo Therapeutics*
* Matters handled before joining Freshfields.
Carlo Felizardo
700 13th Street, NW
10th Floor
Washington, DC 20005-3960