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 

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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

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Common FDA Review Questions to Sponsor

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Common ADaM Questions to Sponsor

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Common ADaM Issues

 Rejections

 Errors 

 Warnings

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Common ADaM Pinnacle 21 Compliance Issues

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Differences with PMDA Questions and Issues

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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



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