What's happening?

The Drug Supply Chain Security Act (DSCSA) will ensure the complete traceability of prescription drugs at all levels of the supply chain in order to combat counterfeits in the industry, coming into full effect in just six months’ time. 

The Drug Supply Chain Security Act (DSCSA) comes into full effect in only six months’ time, having been originally signed by President Obama in 2013.

Careful planning is required when attempting to move a promising drug candidate to first-in-human (FIH) trials. Both safety and the cost effectiveness of the new drug must be taken into account.

The European Falsified Medicines Directive (EU FMD) comes into effect in February 2019, which only leaves a couple of months for pharmaceutical companies and contract manufacturing organisations (CMOs) to achieve compliance.

The European Falsified Medicines Directive (FMD) comes into effect in February 2019 in order to tackle counterfeiting in the pharmaceutical industry, an issue the World Health Organisation (WHO) estimates affects up to one in ten medicines in poorer countries. 

The EU Falsified Medicines Directive (FMD) deadline looms ever closer, coming into effect in February 2019.

As the deadlines for both US and European serialisation enforcement are imminent, companies have a lot to consider when attempting to implement the necessary changes to ensure compliance.

As only the molecular species of the drug at the absorption site can cross the nasal epithelium, sufficient drug solubility is a prerequisite for any absorption.

With the Falsified Medicines Directive (FMD) deadline in February 2019 drawing closer, many CDMOs will be faced with an organisational upheaval in preparation for the new regulation.

Taking a promising drug candidate from the laboratory to first-in-human (FIH) studies is a complex and multi-faceted process.