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

7:13:56

REdI Annual Conference 2024: CDER (Drugs) Innovation in Medical Product Development (Day 2 of 2)

15:39

mRNA COVID Shots Cause Myocarditis

22:06

ICH Q11 Q&A - A Supporting Document for the Selection and Justification of Starting Materials

15:34

GDF2025 – D2S17 - Case Studies of Using Alternate Reference Standard in Bioequivalence Studies

21:47

GDF2025 - D2S02- Nitrosamine Related Guidance

20:39

GDF2025 – D2S16 - Orange Book Drug Marketing Status

18:21

GDF2025-D2S08-Common Clinical Deficiencies in ANDAs Containing Comparative Clinical Endpoint Studies

18:50

GDF2025-D2S11- Common Deficiencies in Drug Master Files (DMFs)

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