Overview
The FDA recently released two draft guidance documents, “Development of a Shared System REMS” and “Waivers of the Single, Shared System REMS Requirement.” These guidances establish the conditions when a Single, Shared System Risk Evaluation and Mitigation Strategy (SSS REMS) is required or may be beneficial to sponsors, and how to request a waiver from a SSS REMS. While the FDA may require generic drug manufacturers to share an SSS REMS with the listed drug manufacturer in order to manage and mitigate the drug’s potential safety risks, SSS REMS are very difficult, and in some cases impossible, to achieve and can be a potential reason for delayed generic drug entry to the market.
In this 90-minute webinar, experts will discuss the impact of these guidances on both the medical products community and on public health and access. The webinar will also cover issues companies face in developing an SSS REMS, and the impact the CREATES Act, if passed by Congress, would have on addressing REMS concerns.
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Speakers
Elaine Lippmann, Senior Regulatory Counsel, FDA – CDER
Lynn Mehler, Partner, Hogan Lovells US LLP
Rachel Turow, Executive Counsel – Regulatory Law, TEVA Pharmaceuticals USA, Inc.
Moderated by Frederick Ball, Partner, Duane Morris LLP and Treasurer, FDLI Board of Directors
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LYNN MEHLER is a partner in the Hogan Lovells’ Pharmaceutical and Biotechnology practice. She advises clients on a range of FDA and DEA regulatory matters. She has worked extensively on the approval process for new drugs and on safety issues, including developing and modifying Risk Evaluation and Mitigation Strategies (REMS), and negotiating shared REMS with generic applicants. Lynn spent 12 years with the FDA’s Office of the Chief Counsel, where she advised the agency on drug safety matters, including at approval and those leading to labeling changes, REMS, and product withdrawal.
RACHEL TUROW is Executive Counsel – Regulatory Law at Teva Pharmaceuticals Ltd. In this role, Rachel provides regulatory legal support to Teva’s specialty and generic pharmaceutical businesses, and supports Teva’s drug-device combination products and digital health projects. Previously, Rachel was Director, Regulatory Policy, at Novo Nordisk Inc. Prior to joining Novo Nordisk, Rachel spent five years at FDA. She was a Regulatory Counsel in CDER’s Office of Regulatory Policy and she served as Special Assistant to Jeff Shuren, Director of CDRH. Rachel holds a JD and MPH from the University of Michigan and a BA in Biology from Stanford University. 
FREDERICK (RICK) R. BALL is located in the Boston office of Duane Morris LLP. Mr. Ball focuses his practice on assisting companies or individuals when they are adverse to state or federal governments, including administrative, civil and criminal matters, with the FDA, FTC, DEA, CMS, OIG and other federal and state regulatory agencies. He serves as a team lead for the Duane Morris Life Sciences/Biotech industry group. Mr. Ball helps pharmaceutical companies, biologics manufacturers, medical device manufacturers, contract service providers, food companies (including supplement manufacturers), pharmacies, long term care providers, and other health care providers navigate the complex challenges faced by state and federal regulation of their industries including complying with current Good Manufacturing Practices, price reporting (AMP, AWP, ASP, etc.), the Foreign Corrupt Practices Act, False Claims Act, and Anti-Kickback Statute, as well as meeting labeling and advertising requirements. Mr. Ball assists companies bring product to market through patent analysis, identifying marketing and approval pathways, and, when necessary litigation. Mr. Ball is experienced in conducting internal investigations and advising companies on actions following the investigation. Mr. Ball emphasizes a team approach to client problem solving and manages matters to achieve client goals both financial and legal.
ELAINE LIPPMANN, JD, is a Senior Regulatory Counsel in the Office of Regulatory Policy in FDA’s Center for Drug Evaluation and Research. Ms. Lippmann provides oversight and leadership in the development of policies, regulations, procedures and guidances, specializing in post-market drug safety. Prior to joining the FDA in 2011, Ms. Lippmann was an attorney at Spiegel & McDiarmid, a law firm that represents municipalities in administrative law and regulatory matters.