HP&M Adds Two FDA Attorneys to its RanksOctober 15, 2015
Hyman, Phelps & McNamara, P.C. (“HP&M”) is pleased to announce that Jenifer R. Stach and Dr. Charlene Cho have joined the firm as associates.
Ms. Stach works as a general practice associate and provides counsel on regulatory matters related to foods, over-the-counter drugs, medical devices, cosmetics, and veterinary food and medicine. Ms. Stach also assists with pharmaceutical compliance, label reviews, corporate compliance matters, and due diligence for mergers and acquisitions.
Before joining HP&M, Ms. Stach worked at FDA for almost five years. During her time at FDA, Ms. Stach worked in the Office of Operations as a liaison to CDRH and CFSAN, CDER as a Regulatory Health Project Manager in the Office of Regulatory Policy, and CFSAN in the Office of Regulations, Policy, and Social Sciences as a Regulatory Counsel. Ms. Stach graduated cum laude from The Catholic University of America Columbus School of Law, and earned a Bachelor of Business Administration in marketing from the University of Notre Dame.
Dr. Cho advises clients about regulatory strategies, compliance matters, and the FDA approval process. With a doctorate in Neurobiology, Pharmacology & Physiology and over five years of experience working at FDA on regulatory policies and procedures, she is well positioned to provide technical advice and counseling on regulatory matters related to biologics, devices, and drugs.
Prior to joining HP&M, Dr. Cho worked as Regulatory Counsel at FDA’s CBER. While there, she worked on a variety of policy and classification issues relating to human cells, tissues, or cellular or tissue-based products (HCT/Ps). She also went on detail to the CDRH, where she worked on jurisdictional matters for medical devices and combination products. Dr. Cho graduated from the Vanderbilt University Law School, and earned her Ph.D. at the University of Chicago. She has a Bachelor of Arts from Smith College.