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Martha Rumore

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Dr. Martha M. Rumore is a pharmacist/attorney admitted to the NY, NJ, DC bars and is a registered patent attorney. She has a Pharm.D. from St. John’s University, a M.S. in Medical Communications and Drug Information from Long Island University, a J.D. from CUNY School of Law, and an LLM in Intellectual Property from the Benjamin N. Cardozo School of Law. Her practice focuses on FDA and healthcare regulatory services and intellectual property.

Martha Rumore

About

For the past 6 years she was Senior Counsel at the Manhattan law firm of Frier Levitt where her practice focused on FDA regulatory, Board of Pharmacy, DEA and Intellectual Property. She regularly advises on 503A and 503B compounding, particularly GLP-1s and peptides, Drug Quality and Security Act (DQSA) compliance, Board of Pharmacy and DEA regulation of pharmacy, and a myriad of FDA matters ranging from API importation, compounding labeling & advertising review, recalls, pharmaceutical and medical device intellectual property, clinical trial management and cGCPs, investigator brochures, 510(k) and PMA submissions, protocol development and review, formulary support, investigational drug labeling, to ADE reporting and medication safety issues.

She has 20 years of law firm experience in the area of Food, Drug & Cosmetic Law, and pharmaceutical intellectual property. She has also worked in the pharmaceutical industry and hospital pharmacy in Drug Regulatory Affairs, both at the Director level. She directed the clinical research department of Glenbrook Laboratories/Sterling Drug as Associate Director, Medical Affairs. She taught Drug Regulatory Affairs at Arnold & Marie Schwartz College of Pharmacy and Touro College of Pharmacy. She currently teaches Food, Drug & Cosmetic Law at Maurice A. Deane School of Law at Hofstra University.

Martha is a frequent lecturer, especially with regard to 503A compounding and DSCSA and has over 200 publications and presentations. She is a Fellow and former Trustee of the American Pharmacists Association. She is also a former Board member of the American Society for Pharmacy Law and the Accreditation Counsel for Pharmacy Education and is a three time recipient of the Larry Simonsmeier Legal Writing Award. As a former compounding pharmacist herself, Martha has developed unique insights and in depth knowledge into FDA and Board of Pharmacy compliance for 503A compounding and 503B outsourcing facilities and is passionate in advocating for pharmacists and pharmacies.

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