Impurity deficiencies in submissions are remarkably consistent. Subathra Ramamoorthy, Veranova, explains how to catch them ...

Jaenisch, Muraru, and Pandey discuss how regulators will audit pharma against its own AI policies and ways QA and regulatory ...

CDMOs announced expansions, exhibitors showcased automated equipment, and supply chain strategy discussions were a focus at ...

USP’s Sheehan and Liu talk at AAPS PharmSci 360 abou getting novel excipients past the monograph hurdle through early engagement with FDA.

Mitigating nitrosamine risk requires assessing each product individually and chasing zero nitrite in pharmaceutical excipients is often impractical and costly.

Subathra Ramamoorthy, Veranova, on how forced degradation and trace impurity profiling in potent APIs shape regulator-ready ...

The agreement between CDER and OII with allow for coordinated marketing application assessments and inspections.

Pharmaceutical Technology serves as the connection to bio manufacturing and development, featuring regulatory updates and ...

Clinical, manufacturing, safety, and commercial teams all lean on shared data. They need to agree on who publishes each data product, who can use it, and what evidence goes with it.

Nitin Kumar Swarnakar, PhD, global application lab manager at BASF in Tarrytown, spoke with PharmTech at AAPS PharmSci 360 ...

In October, FDA reorganized rare disease development around a fit-for-purpose framework and a new pathway for individualized gene editing. Regulators in Europe and the UK set out long-term plans for ...

Aleksandra Zuraw, senior veterinary pathologist at Charles River, discusses how chain of custody, good laboratory practice, ...