Quality Systems

August 02, 2023

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

August 02, 2023

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

August 02, 2023

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

August 02, 2023

Environmental monitoring data can help keep sterile environments sterile.

August 01, 2023

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

August 01, 2023

The guidance document outlines recommendations to limit potential carcinogenic risk.

August 01, 2023

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

July 28, 2023

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

July 27, 2023

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

July 25, 2023

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