When does 1+1 = 3 ... 4 ... 5 ... or even more? When a creative pharmaceutical manufacturer successfully combines two existing patents to create what amounts to a new Rx.
But FDCs do not come without hurdles. To be successful, FDCs must overcome:
Sign up now for an all-new webinar from FDAnews on overcoming hurdles to FDC development. Here’s a taste of what you’ll learn in just 90 profit-building minutes:
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As R&D pipelines shrink and the patent cliff draws nearer, FDCs hold out hope for reaching untapped patient segments, protecting existing branded business, and challenging rivals with drugs in the same class.
Kathleen A. Peterson is a senior associate in the Health Care and Life Sciences Practice at Epstein Becker & Green, in the firm's Washington, D.C. office, where she practices in the Pharmaceutical Industry Health Regulatory Practice Group. Ms. Peterson has provided health regulatory counsel to a range of industry clients, including pharmaceutical and biological manufacturers, distributors, PBMs, managed care organizations, specialty pharmacies, medical education companies, GPOs and investment firms.
Ms. Peterson's experience includes: reviewing and analyzing the impact of state and federal legislative developments, including health reform; counseling regarding government drug pricing calculations; analyzing contracting, reimbursement and fraud and abuse issues in connection with federal and state healthcare programs (including Medicare Part D, Medicare Part B, and Medicaid); counseling regarding marketing practices, rebate contracting practices, grants, coupon programs, consulting relationships, CME programs, medical communications, drug importation, repackaging, drug sampling, state marketing and price disclosure laws, false claims, kickbacks and inducements; coordinating responses to government investigations and inquiries, as well as conducting internal compliance reviews; implementing corporate compliance programs and performing compliance training at both the field and management levels; advising on various FDA regulatory issues, including DDMAC compliance, Phase IV trials and REMS.
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