FDA Reviewers

FDA Requires CDISC submissions - estudy, webinar, cdisc.org, data standards catalog, FDA Reg, FDA Standardsblog, Kit 1, Kit 2, Kit 3, Kevin, CFAST, Study Data Standard 

See Real World Data

l1. Industry Experiences Submitting Standardized Study Data to Regulatory Authorities, Vincent Guo, Janet Low, Kiran Kundarapu, Cathy Michalsky, Todd Case [Presentation]

2. Information Requests During an FDA Review, Hong Qi, Lei Xu, Mary Varughese

3. Challenges of Submitting Electronic Study Data to Two Authorities: PMDA and FDA, Torsten Petsching, Nick De Donder

4. EMA, Health Canada, FDA and PMDA: Four agencies tackle Data Sharing. Synergies and Differences, Jean-Marc Ferran, Liz Roberts

5. Submission of software programs to regulatory agencies, Maria Dalton

6. Electronic Submissions - The Requirement for Standardized Study Data [Presentation]

7. Evidence of Clinical Effectivess and Data Requirements for an NDA [Presentation]

8. Formal Meetings Between the FDA and Sponsors or Applicants of PDUFA Products Guidance for Industry

9. The Y2K17 Bug! Using Metadata to Respond to PDUFA V Requirements Vincent J. Amoruccio

10. The Evolution of FDA Regulatory Submissions in the PDUFA Era

11. Getting Rid of Bloated Data in FDA Submissions


Common FDA Review Questions to Sponsor


Common ADaM Questions to Sponsor


Common ADaM Issues





Common ADaM Pinnacle 21 Compliance Issues


Differences with PMDA Questions and Issues


PhUSE Guidelines

SDTM / ADaM IG FAQs  Working Groups

FDA and PMDA Study Data Submission Distinctions

Data Standards for Non-interventional Studies

Industry Experiences Submitting Standardized Study Data to Regulatory Authorities

Powered by Wild Apricot Membership Software