Quality Systems

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

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

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

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.

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

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

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

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

Impurities and batch-to-batch variability present the biggest challenges.

New child-friendly treatment options and initiatives are improving the outlook of children living with HIV in Europe.

FDA has spurred investment to create and develop 600 therapies.

Proposed regulatory changes signal a major overhaul of legislation governing pharmaceuticals and healthcare in Spain.

A risk assessment should be performed as part of the CAPA process, says Susan J. Schniepp, distinguished fellow at Regulatory Compliance Associates.

A further setback to the publication of the pharmaceutical legislative changes in Europe may mean time is running out for appropriate review before 2024 parliamentary elections.

FDA has approved Evkeeza for young children with homozygous familial hypercholesterolemia.

Takeda received approval in Japan for a subcutaneous injection formulation of Entyvio (vedolizumab) for treating ulcerative colitis.

Pierre Luzeau, CEO of Seqens, discusses Seqen's commitment to sustainability and how one can work toward it within their own company.

The Supreme Court heard oral arguments concerning the legitimacy of “genus clauses” in bio/pharma patents.

Narcan, from Emergent Solutions, will be the first naloxone product permitted for use without prescription by FDA.

A new Interagency Working Group for Bayh-Dole will review the government’s authority to revoke licenses for medical products.

How confident are you in your lab results? This paper explores this question and, by way of a worked example, provides a methodology to answer it.

27 drugs within Medicare will face penalties for having their prices raised faster than the rate of inflation.

Technological advances hold promise for mitigating human error in the pharmaceutical industry, especially in quality assurance/quality control, by reducing the incidence of, and risk associated with, mistakes.

A phase-appropriate analytical development strategy is crucial, especially for complex (formulated) drug substances.

The impact of the potential ban would have serious consequences for the availability of many drugs for European patients.