Regulatory Oversight and Compliance

Takeda has received FDA approval for HYQVIA, a subcutaneous immunoglobulin for the maintenance treatment of chronic inflammatory demyelinating polyneuropathy.

The agency recommended 77 drugs for marketing authorization in 2023, including 39 new APIs.

FDA’s Center for Drug Evaluation and Research released its report on new drugs approved in 2023.

The agency is reviewing data on secondary malignancies related to T-cells for approved CAR T-cell medicines.

The European Medicines Agency safety committee says there is a potential risk of neurodevelopment disorders in children born to men treated with valproate.

Harmonization of global regulations fosters innovation and ensures quality medicines.

FDA is anticipating how AI may advance manufacturing and improve supply chain security.

The SD File format offers benefits for KASA and cheminformatics to support regulatory submissions.

Quality Quartets may be used to achieve knowledge-driven, risk-based approaches to commissioning and qualification that are consistent with ICH Q9(R1) principles.

This paper explores the relationship between investing in pharmaceutical manufacturing risk reduction and meeting business objectives.

Recent research and perspectives shed light on an opportunity to better connect risk and knowledge through improved integration of systems.

MHRA has granted a Clinical Trial Authorization to PharmaKure for its oral combined drug for the treatment of mild cognitive impairment.

Revolutionary therapies restructure pharmaceutical manufacturing.

European bio/pharma companies have no choice but to invest and adapt to the evolving industry needs.

A thoughtfully constructed QRM Master Plan translates the strategy and enables a risk-based approach.

UK scientists are once again able to participate in the Horizon European research programme thanks to a deal struck in 2023.

Analytical methods and tools play a pivotal role in cleaning validation.

The EHDS aims to increase access to health data, but how will it impact pharma?

The midterm report of the European Medicines Agencies Network Strategy finds that the network has strengthened and is on track to achieve its objectives.

WHO provides a look at the world’s health as the agency turns 75.

The final guidance document provides recommendations for designing a new registry or using an existing registry to support decisions regarding safety and effectiveness of a drug.

The agencies published a joint guidance document regarding quality development for breakthrough therapies and PRIME programs.

The Multi-annual AI Workplan creates a strategy to maximize the benefits and manage the risks of artificial intelligence.

Technical, regulatory, and personnel considerations characterize pharmaceutical compounding.

The guidance document discusses the impact of clinical pharmacology considerations on peptide drug development.