FMD: six months, six thoughts

Today marks exactly 6 months before the Falsified Medicines Directive (FMD) comes into force

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Drug application for Intuniv to treat adult ADHD

Shionogi has filed an application in Japan to expand the application to include adults with the disease

FDA to review Duaklir and Tudorza from Circassia

The US regulatory body has accepted for filing and review the medications intended for use in the treatment of chronic ...

GlobalData finds North Americans least informed about GDPR in Pharma

North Americans were the least likely to say that they feel informed about the requirements of the General Data ...

The countdown to the Falsified Medicines Directive

The Falsified Medicines Directive (FMD) introduces harmonised measures to fight falsification, ensure that medicines ...

Tracking technology takes centre stage at Cleanzone 2018

The cleanroom trade show on 23–24 October in Frankfurt will showcase the latest trends on access control, monitoring ...

UK clinical research post-Brexit

Dr Sheuli Porkess, Deputy Chief Scientific Officer of the ABPI here discusses the future of clinical research as the UK ...

Brexit trade bill: Not yet

The UK has decided it will continue to be involved with the European Medicines Agency (EMA) after Brexit. Paul Brooks, ...

Why the new ePrivacy Regulation must be on your corporate radar

Now that the hype and fury regarding the new GDPR has died down, manufacturing and engineering companies will have to ...

Approval of AKYNZEO oral formulation in Korea

CJ Healthcare plans to launch the oral formulation in Korea by the end of the year

Revised WFI guidelines offer greater choice of techniques

Distillation has long been the method of choice for the production of water for injection (WFI) for the biop ...

Maintenance across borders

Here, Dave Friar, International Operations Director at Boulting, international engineering solutions provider, ...

Open tech standards hold the key to better sponsor-CRO collaboration

Sponsors are under ever-increasing pressure to reduce the cost of drug development while accelerating time-to-market, ...

US FDA approves Beximco pharma Nadolol tablet

US FDA approves tablet to treat high blood pressure and angina from the generic pharmaceutical manufacturer, based in ...

MPs back amendment to keep UK in EU medicines regulatory network

Industry insiders comment on disruptions to the supply of medicines post-Brexit and what the MPs backed amendment means ...