Regulatory Oversight and Compliance

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.

The decision was issued in a joint statement by the FDA Commissioner and Chief Scientist, and effective on April 11.

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.

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.

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.

The recent document will guide the use of DHT-derived data in regulatory decision-making for drugs and biological products.

The decision was based on results from the PROpel Phase III trial.

This approval makes the drug the first and only targeted medicine indicated to treat this population of children in Europe and the United States.

Additionally, the MSG discussed plans to mitigate shortages of antibiotics for the next autumn and winter season.

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.

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

Manual aseptic operations make quality practices necessary in the manufacturing of compounded drugs.

By leveraging certain strategies, organizations can effectively close data gaps and achieve more accurate and effective machine learning models in pharmacovigilance.

FDA has approved Acadia Pharmaceuticlas’ Daybue (trofinetide), the first treatment for Rett syndrome, a rare genetic disorder.

FDA has approved Pfizer’s ZAVZPRET (zavegepant), a new nasal spray treatment for migraine.

FDA is seeking $7.2 billion to enhance food safety and advance medical product availability.

Even after an FDA advisory panel voted 14–1 in October 2022 to remove the drug, Makena manufacturer Covis Pharma continued to press for some continued access to the therapy.