The U.S. Food and Drug Administration (FDA) often schedules an EMDAC meeting to address applications for agents from diabetes to weight loss, lipid lowering to thyroid dysfunction. Between these product approval meetings FDA often convenes to discuss the safety and labeling of currently marketed agents (e.g., treatments for diabetes and triglycerides) as well as to encourage the articulation of new standards for drug development (e.g., the role of cardiovascular assessment in the preapproval and post-approval settings for drugs and biologics developed for the treatment of obesity) and the review of post-approval outcomes studies that call previous indications or approvals into question.
ECG has extensive experience preparing clients to face the EMDAC. From the results of major outcomes studies that redefine standards of care to orphan drug applications with a tested population of 22 patients, ECG's experience with EMDAC covers the spectrum of meeting topics. We have supported our clients numerous times for product approvals, safety reviews, and current indication defenses in a variety of therapeutic areas, including:
- Agents for Lipid Disorders (statins, fibrates, and novel therapies)
- Growth Hormone Releasing Hormone for HIV Lipodystrophy
- Weight Loss Agents
- Endocrine Disorders
ECG supports clients in preparing for every aspect of the Advisory Committee meeting, from helping guide the development of the briefing document and presentation to preparing for challenging questions, from recruiting panelists for Mock AdComm meetings to the making and managing of extensive inventories of back-up slides, from the building of an AdComm preparation project plan to the travel and logistics of supporting a team in off-site meetings and at FDA's White Oak location.
Having led more than 170 Advisory Committee preparations in general and over 12 EMDAC meetings specifically, ECG has extensive experience guiding client teams through this career-defining event.
Please contact us via email or at +1-201-894-8200 to discuss your needs or to get further information about how we can support your upcoming EMDAC meeting.
