Standards & Regulation

Pharma is urged to tackle the problem of polluted waste water from manufacturing plants.

Sitting Down With Dominic Carolan, CEO of NIBRT.

Are current guidelines around packaging and product degradation up to scratch?

An EMA task force prepares for the worst should the Agency's HQ be affected by Brexit.

More deaths in a cancer immunotherapy trial raise questions over CAR-T safety

The 21st Century Cures Act is passed through US Congress – and includes big plans for the FDA.

Dry powder inhalers are accepted as being complex drug products due to the interactions which occur between the active pharmaceutical ingredients (APIs) and excipients within the formulation and the way this then affects the efficiency of drug delivery by the inhaler device. Obtaining component specific particle size and particle shape distribution data can help with understanding the properties of the formulation as part of formulation or deformulation studies. This application note describes how the combination of automated image analysis with Raman spectroscopy in the Morphologi G3-ID allows the individual components present within a dry powder inhaler formulations to be independently characterized and compared.

Collusion, pollution, and a pricing victory for pharma in California… what’s new in business?

The FDA consults stakeholders over plans to loosen restrictions on off-label drug marketing

Patients don’t always read drug risk information – even when they say they do