Quality Systems

Court Ruling Leaves FDA Authority in Limbo

April 24, 2023

The Supreme Court’s action leaves open the prospect of further rulings that could undermine FDA’s approval process.

CPHI North America: Investors and Pharma Expect Manufacturers to Build ESG Into Operations

April 18, 2023

Bob Girton, partner at Edgewater, discusses best practices for how pharma manufactures should incorporate sustainability into their operations.

AbbVie Receives European Commission Approval for Crohn’s Disease Therapeutic

April 18, 2023

AbbVie’s RINVOQ has received European Commission approval for the treatment of moderately to severely active Crohn’s disease.

FDA Approves Gamida Cell’s Cell Therapy for Treating Blood Cancers

April 18, 2023

Gamida Cell’s therapy is meant to reduce the risk of infection following stem cell transplantation.

Caribou Biosciences Gets FDA Granted Fast Track Designation for Allogeneic CAR-T Cell Therapy

April 14, 2023

FDA has granted fast track designation to Caribou Biosciences for its allogeneic CAR-T cell therapy for relapsed or refractory multiple myeloma.

Pharma Leaders Rebuke Federal Judge’s Ruling on FDA Authority

April 11, 2023

A document signed by members of more than 400 companies and investment firms decries the decision made by a federal judge concerning mifepristone, a medication used in abortions.

FDA Regulatory Authority Under Attack

April 10, 2023

Will court challenges to FDA’s oversight authority open the door for multiple lawsuits to block agency decisions on all sides?

FDA Is Hiring!

April 07, 2023

The agency is dealing with high demand for staff because of a surge in the development of cell and gene therapies.

FDA Backs Randomized Trials for Accelerated Drug Approval

April 07, 2023

FDA aims to address mounting criticisms of its accelerated approval pathway.

Empowering Pharmaceutical Quality Control Laboratories through Strategic Change Management

April 05, 2023

Change management is central to the evolution of quality control laboratories, but what factors can maximize patient outcomes?