Ora Aligned For The Future Redi - May 29-30, 2019

ORA Aligned for the Future (1of15) REdI – May 29-30, 2019

U.S. Food and Drug Administration

CDER Industry Assistance Resources (13of15) REdI – May 29-30, 2019

U.S. Food and Drug Administration

What can CDER do for you? (3of15) REdI Annual Conference – May 29-30, 2019

U.S. Food and Drug Administration

Meetings: Pre-submission and Special Programs (4of15) REdI Annual Conference – May 29-30, 2019

U.S. Food and Drug Administration

NDA and BLA Application Review Process (6of15) REdI Annual Conference – May 29-30, 2019

U.S. Food and Drug Administration

Electronic Common Technical Document (eCTD) and Study Data (7of15) RedI – May 29-30, 2019

U.S. Food and Drug Administration

Office of Regulatory Affairs Update (1of14) REdI 2018

U.S. Food and Drug Administration

A Medical Officer’s Approach to NDA/BLA Review (8of15) REdI Annual Conference – May 29-30, 2019

U.S. Food and Drug Administration

FDA Regulatory Education for Industry (REdI) – Devices and Biologics Track

U.S. Food and Drug Administration

Post-Market Surveillance under MDR (IVDR) – not a regulatory burden only

Aligned Elements

Top FDA Warning Letters Related to Calibration with Walter Nowocin

Perry Johnson Laboratory Accreditation Inc.

Regulatory Education for Industry (REdI) Annual Conference 2022 - Day 1 - Part 3

U.S. Food and Drug Administration

Session Nine: Evolving Alliances

RUSI