Our Latest Thinking

Regulatory Communications

Pink Sheet: How To Win Over The EU CHMP At Virtual Meetings

Time to Get Real About Real-World Evidence – More Action, Less Talk Could Accelerate Access to New Medicines, Pharma Industry Experts Say

What You Need to Know About Application Orientation Meetings (Part 2): How to Prepare for Success

What You Need to Know About Application Orientation Meetings: Laying the Foundation

The Stakes Don’t Get Higher Than This: Racing Against the Virus to Help Moderna’s COVID-19 Vaccine Receive Emergency Use Authorization

Op-Ed: Leading by Example on COVID Vax Won't Sway Black Community

Time for Change? Has the Time Come for the Pharmaceutical Industry to Accept Modest Prices?

Webinar: A Rare Behind-the-Scenes Look at CHMP Meetings – Challenges, Opportunities, and the One Shot You Have at Winning

When Addressing CHMP Major Objections, Don’t Forget About Benefit-Risk

Gaining Market Authorisation in Europe: Responding to Complex EMA Questions When You’re on the Clock

CHMP Meeting Success: Providing Clinical Perspective to Overcome Major Objections

Making it Count – Turning Complex Data into a Story with Impact

The Art of Effectively Managing Virtual Presentations and Meetings

Episode 61: Preparing for Virtual High-Stakes Meetings

Session 12: How To Work With The US FDA When You Can’t Meet With Them

COVID-19: Will it be a Catalyst that Moves us Forward in the Drug-Pricing Debate?

Virtual US FDA Advisory Committees May Have One Silver Lining: Available Experts

How We Plan to Rebuild in the Post COVID Economy

A New Kind of FDA Meeting

Our Statement on Racial Injustice and Systemic Racism

Webinar: How to Effectively Communicate with FDA and EMA Regulators – In a Virtual Meeting Environment

Conducting a Successful Mock Meeting, Virtually: A Case Study

COVID-19, Communications and Leadership: What We’re Seeing on the Front Lines

Top 10 Tips on Why Visuals Matter More in Today’s “Virtual” Reality

Top 10 Tips on How to “Bring It” in Today’s Virtual Reality

Top 10 Tips for Effective Virtual Meetings

Keep Calm and Moderate On: The Makings of a Successful Moderator

The Debrief on Briefing Documents: How to Maximize Your Briefing Book for FDA Advisory Committee Meetings

Maximizing the Effectiveness of Data Visualizations in Regulatory Submissions

CHMP Meetings: A Rare Behind-the-Scenes Look at These Private European Regulatory Meetings

Recruiting for a Realistic Mock Advisory Committee Meeting

Recent FDA Changes for Orphan Drugs: What You Need to Know

Running a Realistic Mock FDA Advisory Committee Meeting

Top 10 Rules for Effectively Communicating With Regulators

Do Public Hearing Participants Influence Outcomes of FDA Advisory Committee Meetings?

Achieving Approval for Abuse-Deterrent Opioids in the Era of an Opioid Epidemic

Getting Access Right: Break Down Pharma’s Silos and Convene the Stakeholders

Seven Steps for Success at FDA Meetings

Five Steps to Writing an Effective Presentation for an FDA Advisory Committee Meeting

Preventing and Accounting for Missing Clinical Trial Data for FDA Drug Approvals. Part 1: Prevention

Preventing and Accounting for Missing Clinical Trial Data for FDA Drug Approvals. Part 2: Analysis

Top 10 Tips for Successful Meeting Planning

How to Identify and Organize a Winning Team for Your FDA Advisory Committee Meeting

Tips for Medical Science Liaisons: It’s Not Only About How Much You Know

How to Maximize Your FDA Advisory Committee Preparation Team Regardless of Size

Six Ways to Keep Your Team Motivated During ADCOM Preparation

Path to CDRH Approval: Practices and Preferences of FDA Medical Device ADCOM Members

Preparing for Regulatory Submission: Analyzing Clinical Data to Strengthen the Benefit-Risk Profile

Post-Marketing Plans: An Often-Overlooked Component of FDA Advisory Committee Meeting Discussions

CDER Expedited Pathways: Why Do Some Drugs Get Approved Quicker than Others?

Anticipating Common Questions During an Rx-to-OTC Switch

Impact of Evaluation and Reporting of Age, Race, and Ethnicity on Medical Device Clinical Trials

Avoiding Common Pitfalls at FDA Device Panel Meetings

FDA NDA to ADCOM: Five Tips to Ensure a Smooth Transition

The Danger of Company Groupthink in FDA Advisory Committee Preparations

How to Maximize Early FDA Interactions and Improve Your Chances of Medical Device Approval

Book Review: The FDA Clinical Submission Survival Manual

Webinar: Winning from the Beginning: Best Practices to Increase Your Chances for Successful CHMP Meetings

Webinar: Winning from the Beginning: Best Practices to Increase Your Chances for First-Pass Approvals in Key Markets

Webinar: From Mild-Mannered Scientist to Communications Ironman

Book Review: The FDA Advisory Committee Survival Manual

Webinar: FDA Advisory Committee Prep: Steps for Success

FDA Advisory Committee Member Practices and Preferences: A Survey on CDER Panel Member Influences

FDA Advisory Committee Meetings: What They Are, Why They Happen, and What They Mean for Regulatory Professionals

Early Preparation, Now More than Ever, Is Key to Successful FDA Device Panel Meetings

How Can We Help You?

Get Started