Combined meeting of the Peripheral and Central Nervous System Drug Advisory Committee and the Drug Safety and Risk Management Advisory Committee, with representation from the Risk Communication Advisory Committee.
Antiviral Drugs Advisory Committee
Oncology Drugs Advisory Committee
At ProEd Communications, we created the industry’s first dedicated regulatory communications team 20 years ago to help our clients secure regulatory approvals and obtain the optimum labels for their pharmaceuticals, medical devices, and biologic products.
Since then our dedicated team of physicians, scientists, and communications professionals has helped more companies succeed in the development and regulatory arena than any other communications firm.
We have helped support more than 110 FDA advisory committee meetings and multiple EU oral hearings with an impressive 80% success rate.
We continue to lead the industry by providing the deepest scientific expertise, the most experienced regulatory strategists and development consultants, and the most effective communicators.
When your drug, device, or biologic product goes before an FDA advisory committee, your success depends on your ability to tell a compelling story and to provide clear answers to the committee’s questions.
Our team provides an objective assessment of your product and then helps you define the strategic approach that will ensure product approval.
We work with you to craft your complex data package into a clear and compelling story that demonstrates how your product will fulfill an unmet medical need. Then we train your team to face the spotlight of a public hearing with confidence and poise.
We help you excel on all 3 pillars of advisory committee preparation.
Our science and strategy support is methodical and evidence based. Working with our consultants your team will always be on a trajectory of progress.
Our communications and training approach is personalized and balanced. You will enjoy the training and learn lifelong communication skills.
Our planning and process are effective and least burdensome. With our guidance you will spend your time and money on activities that matter most.
Throughout the process we provide a proven methodology and comprehensive suite of services that allow you to remain focused on delivering your message.