Dr. Kevin Bugin, Ph.D. - Deputy Director of Operations, Office of New Drugs, CDER, U.S. FDA

(55:30)

Janet Woodcock, Director CDER FDA on NORD Registry Program

(6:35)

Director of CDER discusses the pathway for biosimilar drugs

(5:54)

Why FDA Won't Make PAT Mandatory: CDER's Keith Webber

(1:32)

FDas CDER Director discusses the problem of outsourced clinical trials

(3:32)

CDER Director Dr. Janet Woodcock’s Plenary Address at the 2014 PDA/FDA Joint Regulatory Conference

(23:45)

CDER Deputy Director Keith Webber on Process Validation and PAT

(8:24)

Keynote: Pharmaceutical Quality: A Global Priority (CDER) (1/15) Global Quality

(11:36)

Maria Picone, TREND CEO, interviews Janet Woodcock, FDA Director of the CDER

(11:10)

Continual Improvement of CDER BLA Submission, Assessment, and Facility Readiness/Inspection

(5:4:58)

M13A: Bioequivalence for Immediate-Release Solid Oral Dosage Forms - Implementing the Final Guidance

(1:57:16)

Optimizing the Use of RWE in Regulatory Decision Making for Drugs \u0026 Biological Products-Looking Fwd

(3:20:12)

Electronic Drug Registration and Listing (eDRLS) Using CDER Direct – 2024 – Part 1

(2:27:19)

Electronic Drug Registration and Listing (eDRLS) Using CDER Direct – 2024 – Part 2

(3:10:15)

Office of Pharmaceutical Quality (OPQ) Reorganization Webinar

(38:20)

Generic Drugs Forum (GDF) 2024: Regulatory Considerations to Enhance Generic Drug Access - Day 1

(8:6:51)

FDA-MHRA-HC 2024 Joint Symposium (Day 1)

(7:6:50)

Pharmaceutical Quality Symposium 2023: Quality, Supply Chain \u0026 Advanced Manufacturing – D1 – Part 4

(2:16:18)

FDA Clinical Investigator Training Course (CITC) 2024 (Day 1 of 3)

(4:38:30)

CDER's Janet Woodcock Discusses the Future of Drug Development

(1:34)

Introduction to the CDER Town Hall

(1:36)

CDER’s Office of Pharmaceutical Quality’s Use of Remote Interactive Evaluations

(1:12)

Dr Patrizia Cavazzoni, Director, CDER, USFDA | 8th GPQS 23 | 22nd June'23

(15:39)

Office of New Drug (OND) Research: Seeking Collaborators, Funding Opportunities Available (1 of 2)

(41:57)

Communication Best Practices – Interacting with Regulatory Project Managers in CDER/ORO

(34:13)

CDER Town Hall Part 1

(7:52)

Presentation from ShaAvhree Buckman-Garner, Director, Office of Translational Sciences, CDER, FDA

(13:54)

Keynote Overview – CDER Compliance Conference

(6:7)

Update on CDER’s Quality Management Maturity Program

(21:9)

CDER’s Role in Public Health Emergency Response and Medical Countermeasure Development

(1:18:40)