2015 PDA/FDA Joint Regulatory Conference
Pharmaceutical Technology spoke with Monica Caphart, FDA, and Susan Schniepp, PDA, about the 2015 PDA/FDA Joint Regulatory Conference taking place in Washington, DC, in September.
Monica Caphart, leveraging and collaboration program manager with the Division of Human Resource Development at FDA, and Susan Schniepp, chair of PDA Regulatory Affairs and Quality Advisory Board, spoke with BioPharm International about the theme of the 2015 PDA/FDA Joint Regulatory Conference, how legislative tools have improved the quality of drug products, and what attendees can expect from conference sessions and regulatory authority interactions.
The 2015 PDA/FDA Joint Regulatory Conference will take place in Washington, DC, September 28–30, 2015.
Regeneron Treatment for Multiple Myeloma Gets Conditional Marketing Approval from EC
April 29th 2025The indication is specific to patients who have received at least three prior therapies, including a proteasome inhibitor, immunomodulatory agent, and anti-CD38 monoclonal antibody, and have demonstrated disease progression on the last therapy.
MHRA Approves GSK Therapy Combinations for Multiple Myeloma
April 21st 2025Belantamab mafodotin is approved in combination with bortezomib plus dexamethasone in patients who have had at least one prior therapy, and in combination with pomalidomide plus dexamethasone for those who have had a prior therapy including lenalidomide.
