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Standards & Regulation

Business & Regulation Standards & Regulation

A New Administration

Despite controversies, Robert Califf will finally take the reins at the FDA.

Business & Regulation Business Practice

Hail the Tattletale

Does incentivizing informants deter off-label drug marketing ? Should other countries follow suit?

Business & Regulation Formulation

Lean, Mean Stability Machine

The stability of drug formulations is essential. But what should be monitored – and how often?

Business & Regulation Standards & Regulation

Therapeutic Orphans

Neonates have been underserved, potentially missing out on life-giving scientific advances.

Manufacture Standards & Regulation

Problem Plants

Regulators come down hard on facilities that come up short.

Manufacture Standards & Regulation

Competition Crackdown

The UK Competition and Markets Authority (CMA) has handed out a £37.6 million fine to GSK for paying out “value transfers totaling over 50 million pounds” to competitors between 2001 and 2004 to delay the introduction of generic versions of its branded anti-depressant drug, Seroxat (paroxetine).

Discovery & Development Business Practice

Reverse engineering of a pharmaceutical formulation

The Morphologi G3-ID can be used to generate component-specific particle size and shape data required to aid the reverse engineering of solid oral dose formulations. Here, we provide an example case study for a powder formulation.

Business & Regulation Business Practice

The Adverse Event Data Advantage

A personal experience led us to examine how adverse drug events data can be used to benefit the industry.

Business & Regulation Business Practice

The CMO Serialization Threat

The serialization deadlines are coming. It may seem an age away, but preparing for serialization is not as straightforward as you may think. Do you really want to get left behind?

Business & Regulation Standards & Regulation

Are You REACH Ready?

The final deadline for the European Union’s REACH regulation is approaching – and the home stretch will be the most challenging, especially for pharma companies that have failed to recognize their role.

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