FDA Releases Guidance on Generic-Drug Development
The agency releases guidance on controlled correspondences related to generic-drug development.
As part of the implementation of the Generic Drug User Fee Amendments of 2012 (GDUFA), FDA has released guidance that provides information on the process for submitting correspondence to the agency requesting information related to generic-drug development. The guidance also describes FDA’s process for providing communication related to such correspondence.
Included in the guidance are the definition of a controlled correspondence, guidelines for submitting a controlled correspondence, and information on requests related to inactive ingredients and Q1/Q2 formulation assessment controlled correspondence review disciplines. The guidance also includes information on communications from FDA to requestors that submit controlled correspondence.
Source: FDA
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.
