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FDA Guidance for Industry

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

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

Moving in Harmony: Aligning a Multidisciplinary Team on a Communication Strategy

4 min read

Five best practices for aligning a multidisciplinary team on a persuasive communication strategy.

AdComms, Audience Analysis, Communication Strategy, NDA/BLA, Regulatory Submissions, Team Alignment