Sbia Program Overview - Redi 2020

SBIA Program Overview - REdI 2020

U.S. Food and Drug Administration

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

U.S. Food and Drug Administration

CDER Export Certificate Program - REdI 2020

U.S. Food and Drug Administration

Overview of Postmarketing Drug Safety Reporting Requirements - REdI 2020

U.S. Food and Drug Administration

FDA Drug Manufacturing Inspections - REdI 2020

U.S. Food and Drug Administration

Real-world Evidence for Drugs, Biologics, and Devices - REdI 2020

U.S. Food and Drug Administration

Questions and Panel Discussion – Post-approval CMC and Manufacturing - REdI 2020

U.S. Food and Drug Administration

Drug Shortages - REdI 2020

U.S. Food and Drug Administration

Enhanced Drug Distribution Security – DSCSA Implementation Updates - REdI 2020

U.S. Food and Drug Administration

ORA Aligned for the Future (1of15) 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

Restructure of the Office of New Drugs (OND) - REdI 2020

U.S. Food and Drug Administration

Components of New Drug Application and Biologics License Application (5of15) REdI– May 29-30, 2019

U.S. Food and Drug Administration

CDER NextGen Portal

U.S. Food and Drug Administration

CDER Small Business and Industry Assistance Overview (12of14) REdI 2018

U.S. Food and Drug Administration

Lifecycle Changes to Chemistry, Manufacture, and Controls in NDAs - REdI 2020

U.S. Food and Drug Administration

Post-Approval Submission of Promotional Materials to the OPDP - REdI 2020

U.S. Food and Drug Administration

Division of Risk Management: Overview of Review Activities and REMS - Pharmacovigilance 2020

U.S. Food and Drug Administration

Overview of Post-approval Chemistry, Manufacture, and Controls (CMC) Changes to an NDA - REdI 2020

U.S. Food and Drug Administration

Post-approval Considerations for Changes to Manufacturing Process and Facilities - REdI 2020

U.S. Food and Drug Administration