Quality Systems

The investigational drug was developed to activate a novel uptake pathway, allowing antineoplastic drugs to combat solid tumors more successfully.

Lower levels of an active ingredient may result in unexpected pregnancies.

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

An intelligent drug development paradigm can enable small pharma to implement an effective early drug development approach.

The industry is taking steps to automate the final product inspection process for complex therapeutics.

Current good manufacturing practices for oral solid dosage forms protect the product from contamination and potential errors.

What impact will EMA’s decision to phase out COVID-19 regulatory flexibilities have on the pharma industry?

Manufacturer lawsuits prompt CMS to [slightly] modify pricing plan.

The more information shared, the smoother the approval process, says Susan J. Schniepp, distinguished fellow with Regulatory Compliance Associates.

An intelligent drug development paradigm can enable small pharma to implement an effective early drug development approach.

Environmental monitoring data can help keep sterile environments sterile.

The program aims to aid submissions from external stakeholders and FDA staff.

The guidance document outlines recommendations to limit potential carcinogenic risk.

In this episode, David Tisi and Reenal Gandhi provide expert insights into advances and innovations changing the drug dosage form landscape.

Pandemic, PBM, and other policies on hold during the summer recess.

Tarsus Pharmaceuticals’ Xdemvy (lotilaner ophthalmic solutions) is designed to treat Demodex blepharitis by directly targeting Demodex mites.

The damage to the facility, which produces 8% of US injectable drug consumption, should not significantly affect the current supply.

The framework is now expanded beyond COVID-19 vaccines and treatments.

The paper highlights the potential of AI in the medicinal product lifecycle and the approach that developers should take with it.

These recommendations will keep key antibiotics for respiratory infections available when they are needed most.

The document’s recommendations outline what studies and reports are required for changes to cell and gene therapy manufacturing.

The new drug may help vulnerable children resist RSV in the coming fall and winter season.

Laboratoire HRA Pharma norgestrel is the first daily tablet for nonprescription use to prevent pregnancy.

Eisai’s lecanemab-irmb was converted from an accelerated approval to a traditional approval.

The agency is reviewing the medicines after receiving reports of self-injury and suicidal thoughts in patients using the type 2 diabetes treatments.