FDA Issues Guidance on Lot Distribution Reports for Biologics
Guidance provides labeling standards and an implementation guide for electronic submission of lot distribution reports.
FDA has issued a guidance document on how manufacturers of products under biologics license applications (BLAs) should electronically submit lot distribution reports (LDRs). Title 21 of the Code of Federal Regulations 600.81 requires that LDRs be submitted to FDA in an electronic format for FDA to process, review, and archive.
The guidance document creates the Structured Product Labeling (SPL) standard and vocabulary for electronic submission of LDRs as well as provides an implementation guide and validation procedures. FDA recommends manufacturers use the same message exchange format currently used for registration and drug product listing.
The guidance also states that FDA will link the Center for Biologics Evaluation and Research’s lot distribution database with FDA’s Adverse Event Reporting System and Vaccine Adverse Reporting System databases.
Source: FDA.gov
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.
