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 ...

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.

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

The PharmTech team focused on its coverage of AAPS PharmSci 360 this week, conducting interviews with experts on a range of ...

Continuous overall equipment effectiveness can be used to pinpoint hidden downtime and process bottlenecks in real time.

Subathra Ramamoorthy, Veranova, on when to escalate to structural elucidation and pair orthogonal techniques when characterizing an impurity.

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

The PharmTech team focused on its coverage of AAPS PharmSci 360 this week, conducting interviews with experts on a range of topics including formulation platforms, AI, amorphous solid dispersions, and ...

Manish Baviskar, Hubot CDMO, explains which AI skills validation engineers need first and why AI model updates must go ...

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