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Articles, insights, and advice to help you achieve your drug development and approval goals

Bridging the Spectrum of Expertise: Preparing for a Meeting of the Cellular, Tissue, and Gene Therapies Advisory Committee (CTGT)

4 min read

Sponsors who fail to align this heterogeneous audience risk losing this Committee's support

AdCommPrep, AdComms, CTGT, FDAAdvisoryCommitteeMeeting, Regulatory, RegulatoryAffairs, SpectrumOfExpertise

Overcoming Communication Challenges for the Approval of New Therapies for Rare Diseases

8 min read

“When you hear hoofbeats, don’t expect to see a zebra.”

Accelerated Approval, AdComms, Cellular Therapies, Expedited Approval Pathways, FDA ARC, FDA Guidance for Industry, FDA START, Gene Therapies, Rare Diseases, RMAT, Tissue Therapies

Maximizing AdComm Opportunities

6 min read

The most important things sponsors need to know about AdComm preparation.

AdComms, Briefing Document, Communication Strategy, FDA, IT/AV Technology, Presentations, Q&A

How to NOT Botch Your Q&A

7 min read

A single weak response can unravel the credibility of your presentation.

AdComms, Audience Analysis, Communication Strategy, Issue Analysis, Q&A

You’ve Got Issues

6 min read

Failure to identify and address issues represents the biggest threat to regulatory approval.

Issue Analysis, Messaging, Q&A, Regulatory Submissions

Maximizing the Impact of Your Messages: Developing Compelling Messages Based on a Communication Strategy

6 min read

Craft messages that grab and continually renew your audience’s attention.

AdComms, Briefing Document, Communication Strategy, Messaging, NDA/BLA, Regulatory Submissions