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FDA pre-approval inspection of EBR’s WiSE CRT system set for early January

EBR Systems has a US FDA manufacturing pre-approval inspection scheduled for the week of January 6, 2025 Inspection follows: start of substantive review process of pre-market approval submission for ...
Healthline

The FDA Development and Approval Process for Medications and Medical Devices

The Food and Drug Administration (FDA) development and approval process for drugs and medical devices involves multiple phases that ensure the safety and effectiveness of products before and after ...
The American Journal of Managed Care

FDA Issues CRL for Linvoseltamab in R/R Multiple Myeloma

The complete response letter (CRL) was issued based on a pre-approval inspection at a third-party fill/finish manufacturer. Similar to other recent CRLs, this decision was made not based on the drug’s ...
Business Wire

Kemwell Biopharma Facility in Bengaluru Successfully Completes U.S. FDA Inspection for Commercial Drug-Product Manufacturing

BENGALURU, India--(BUSINESS WIRE)--Kemwell Biopharma Pvt Ltd (“Kemwell”), a leading global biologics Contract Development and Manufacturing Organization (CDMO), announced today that its drug-product ...