Rachael Vieder Linowes

Rachael Vieder Linowes draws on over a decade of high-level experience at the U.S. Food and Drug Administration (FDA) to advise clients on issues related to FDA compliance, enforcement, and regulation for medical products. As a former Senior Regulatory Counsel, Rachael provides direct insight into how different FDA Centers and Offices operate, helping clients navigate questions related to product development and regulatory strategy, compliance, enforcement, clinical trial oversight, and emerging regulatory policy.

During her time at FDA, Rachael served as a Senior Regulatory Counsel, primarily within the Office of the Commissioner. Rachael advised senior FDA leaders on complex administrative actions and policy-related matters, such as:

• Hearings: Formal and informal hearing matters (21 CFR Part 12 and 16) addressing proposed debarments, proposed 510(k) substantial equivalence (SE) determination rescissions, and proposed refusals to approve new drug applications, as well as proposed withdrawals of accelerated approval of drugs/biologics
• Appeals and Requests for Administrative Relief: User fee appeals, 21 CFR 10.75 appeals, requests for reconsideration under 21 CFR 10.33, and requests for stays of action under 21 CFR 10.35
• Drug and Device Regulatory Questions: 510(k) SE and not substantially equivalent (NSE) determination challenges, orphan drug exclusivity requests, investigational new drug (IND) clinical hold challenges, new drug determinations, and combination product designations
• Clinical Trial and Clinical Investigator Matters: Institutional review board (IRB) protocol and informed consent review, clinical investigator disqualifications, and clinical investigator reinstatements
• Policy Matters: Citizen petition responses and policy document creation

Rachael participated in the FDA’s IRB where she reviewed proposed clinical trials, including questions surrounding informed consent as well as sponsor and investigator responsibilities. Rachael also participated in numerous cross-Agency working groups collaborating on cross-cutting policy issues and crafting documents, such as the “Accelerated Approval – Expedited Program for Serious Conditions” and the “Investigator Responsibilities – Safety Reporting for Investigational Drugs and Devices” guidances.

Having also held positions within the Center for Drug Evaluation and Research, the Center for Tobacco Products, and the Office of Orphan Products Development, Rachael developed a well-rounded understanding of the relationship between various agency components as well as specialized experience in matters spanning from unapproved drug labeling compliance to orphan drug designation and exclusivity.

Rachael’s contributions during her time at FDA earned her various honors, including the “FDA Outstanding Service Award” and “Commissioner’s Special Citation.”