Consensus Area Summary
| Consensus Area | #a |
|---|---|
| Interaction between industry and the FDA*b | 11 |
| Transparency | 10 |
| Collaboration | 10 |
| Early interaction and the Emerging Technologies Team | 9 |
| Case studies | 9 |
| Changes to approved manufacturing processes* | 11 |
| Approaches to comparability | 10 |
| Post-approval changes | 10 |
| Operating in a global regulatory environment | 11 |
| Consistency across the FDA* | 8 |
| Between individuals (reviewers or inspectors) | 7 |
| Between leadership/policy and reviewers/ inspectors | 3 |
| Guidance documents | 8 |
| ICH Q12 | 3 |
| Manufacturing process development | 7 |
| Specification setting | 4 |
| Using prior knowledge in regulatory filings | 6 |
| Additional regulatory pathways/tools | 7 |
| Education and training | 5 |
a The number represents the total number of interviews where a topic was mentioned. Eleven total companies were interviewed.
b An asterisk (*) is used to identify those topics that were discussed during the afternoon session with both industry and FDA stakeholders present.