Scientific Advice Meetings

Regulatory Responses

Orphan Drug Designations

Fast Track Designations

Breakthrough Designations

Accelerated Approvals

IND/CTA

Pediatric Investigation Plans/Pediatric Study Plans

NDA/BLA/MAA

Nonclinical reports

Meeting Request Letters & Briefing documents

CTD Module 4 Compliance

CTD Module 2

IB

Clinical Evaluation Plans

Clinical Evaluation Reports

Clinical Literature Reviews

PSURs

Clinical Investigation Plans

Summaries of Safety & Clinical Performance

Clinical Trial Protocols

Investigational Medicinal Product Dossiers (IMPD)

Clinical Development Plans

Protocol Synopses & Study Designs

CTD Module 2

Clinical Study Reports & Narratives

Investigator's Brochures (IB)

Development Safety Update Reports

Periodic Safety Update Reports (PSUR/PBRER/PADER)

Safety Narratives

Risk Management Plans

Risk Evaluation and Mitigation Strategies

Benefit-Risk Assessments Annual Reports

Posters

Abstracts

Manuscripts

Journal Selection and Submission Activities

Conference Proceedings

Slide Decks

Plain Language Summaries