Effective regulatory responses are concise and evidence-based, explicitly connecting observations to root cause, corrective ...

The recently opened NJ spray drying facility doubles capacity for amorphous solid dispersions, addressing solubility limits ...

FDA will review discrete IND modules during pre-IND rather than waiting for a full submission, with the goal of de-risking ...

As cell and gene therapies move from bespoke academic protocols into commercial-scale manufacturing, the raw materials underpinning them are emerging as one of the most consequent ...