mRNA COVID Shots Cause Myocarditis

GDF2025 – D2S20 – Closing Remarks

GDF2025 – D2S19 - Questions & Panel Discussion - Session Four

GDF2025-D2S18- Common Bioequivalence Information Requests: Tips for Facilitating the Review Process

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

GDF2025 – D2S16 - Orange Book Drug Marketing Status

GDF2025 - D2S15 - Questions & Panel Discussion - Session Three

GDF2025 – D2S13 - Navigating Challenges in Drug Manufacturing

GDF2025 - D2S12- Common Quality Major Deficiencies in Abbreviated New Drug Applications (ANDAs)

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

GDF2025-D2S10- GDUFA III Impact on Drug Master File (DMF) Assessment

GDF2025 - D2S09 - Questions & Panel Discussion - Session Two

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

GDF2025 - D2S07- Common Bioequivalence Deficiencies in Abbreviated New Drug Applications

GDF2025 - D2S06- Analysis of Common ANDA Major Deficiencies

GDF2025 – D2S05 - Impact of ICH M13A Implementation on Bioequivalence Assessment

GDF2025 - D2S04 - Questions & Panel Discussion - Session One

GDF2025 - D2S03- Bioequivalence Approaches for Nitrosamine Impacted ANDA Applications: Case Studies

GDF2025 - D2S02- Nitrosamine Related Guidance

GDF2025 - D2S01- General Quality Considerations of Drug Products Labeled for Alternate Dosing

GDF2025 - D1S20 - Questions & Panel Discussion - Session Four / Day One Closing

GDF2025 – D1S19 - Common Discrepancies Observed on the Form 356h with the ANDA Submission

GDF2025 – D1S18 - Experiences from Post-Complete Response Letter Scientific Meetings in GDUFA III

GDF2025 – D1S17 - Pre-Abbreviated New Drug Application (ANDA) Meetings: Process and Best Practices

GDF2025 - D1S16 - Overview of the FDA Product-Specific Guidance (PSG) Program

GDF2025 - D1S15 - Questions & Panel Discussion - Session Three

GDF2025 - D1S14 - How to Leverage the Inactive Ingredient Database and Safety Justification

GDF2025 - D1S13 - Assessment of Inactive Ingredients in Generic Drug Applications

GDF2025 – D1S12 - Considerations when Submitting Proposed Excipient Levels in IIG

GDF2025 - D1S11 - Questions & Panel Discussion - Session Two