'Confirmatory study' presentation slideshows

Bayesian Design and Analysis (Clinical Regulatory Perspective)

Bayesian Design and Analysis (Clinical Regulatory Perspective). Celia Witten, Ph.D., M.D. Office Director, OCTGT, CBER, FDA FDA/ASA/Industry Statistics Workshop September 29, 2006 Washington, D.C. Outline. OCTGT Applications: Past Experience/Potential Applications

389 views • 22 slides

Prevnar 13 for Adult Use Pneumococcal 13-valent Conjugate Vaccine (Diphtheria CRM 197 Protein)

Vaccines and Related Biological Products Advisory Committee Meeting November 16, 2011. Prevnar 13 for Adult Use Pneumococcal 13-valent Conjugate Vaccine (Diphtheria CRM 197 Protein). Applicant: Wyeth Pharmaceuticals, Inc Nicolette deVore, Ph.D. Regulatory Reviewer

1.65k views • 22 slides

Endpoints for Past Approvals

Endpoints for Past Approvals. Ramzi Dagher DODP/CDER/FDA. Endpoints in Oncology. Survival (gold standard) TTP (advantages and challenges) DFS (adjuvant setting) ORR (treatment responsible for tumor reduction) Tumor related symptoms/PRO. Clinical Benefit Endpoints : Regular Approval.

298 views • 13 slides

Rare Disease Workshop 5: Post Marketing Confirmatory Studies in Rare Diseases

242 views • 8 slides

One good example of considering gene expressions at the review for approval

One good example of considering gene expressions at the review for approval Taxol : Indicated for the adjuvant treatment of node-positive breast cancer administered sequentially to standard doxorubicin-containing combination chemotherapy. retrospective subgroup analysis

162 views • 4 slides