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Regulatory & Safety: Top Headlines

Impax preparing response to FDA Form 483 with 10 observations

Observations range from improper validation to out-of-specification test results

30-Jul-2014 - Impax Laboratories said it is working to address issues raised in an FDA Form 483 for its Taiwanese manufacturing facility, which was cited with 10 observations following an inspection in late July.

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News in brief

Who are pharma's movers and shakers?

28-Jul-2014 - The latest changes at Bayer, biopharma, and the winner of Professional Woman of the Year in this week's column.

First come, first served? FDA may allow reservation of drug names

28-Jul-2014 - The US Food and Drug Administration (FDA) is inviting public comment on plans to allow drug companies to reserve proprietary names for medicines as early as the end of Phase II trials.

UK Gov should seek licenses for off-patent drugs in new indications says MP

24-Jul-2014 - The UK Government should seek licenses to use off-patent drugs in new indications according to MPs who say there is no incentive for pharma firms to apply for such approvals after a product goes generic.

Is your drug name ok? Run a role-play, says FDA

24-Jul-2014 - Industry insiders have criticised new draft US Food and Drug Administration (FDA) guidance on choosing proprietary drug names, saying simulation studies involving doctors, nurses and pharmacists are time-consuming and unhelpful.

Italy to look at drug pricing during EU presidency

24-Jul-2014 - Italian health Minister Beatrice Lorenzin will focus on making drug National price regulations and decisions more trasnparent during the country's presidency of the EU.

Generics: change in pill shape makes patients 66% more likely to quit

23-Jul-2014 - Switching patients to generic pills of a different shape and colour increases the chances they will end their course of medicine early, according to research.

Feature

Jay-Z and Scarface: pharma staff’s anonymous Wikipedia interests

22-Jul-2014 - Big pharma employees are among the brightest minds in the world, and data released yesterday on their Wikipedia use shows their interests spread beyond drug development into lighter fare.

Regulatory & Safety: Featured news

Spotlight

G-CON: Pfizer investment an endorsement of 'podular' manufacturing

Pfizer investment an endorsement of 'podular' manufacturing, says G-CON

G-CON says a multi-million dollar investment by Pfizer could hasten the “paradigm shift” in pharma manufacturing towards...

US FDA enforcement evolving in India will drive compliance costs

Indian firms must invest in compliance as USFDA ups enforcement, says S&P

Indian drugmakers must invest heavily in compliance processes in response to the US FDA’s “aggressive surveillance” and...

Ease regulations to cure drug industry antibiotic resistance, says RPS

Ease regulations to cure drug industry antibiotic resistance, says RPS

The current model of antibiotic development “is broken,” says the Professor of Pharmaceutical Innovation at Kings College,...

Zogenix adds abuse deterrents to Zohydro painkiller

Zogenix adds abuse deterrents to Zohydro painkiller

Zogenix has modified its much-debated painkiller Zohydro with abuse-deterrent formulations.

Afrezza approval: Validation for Mannkind's drug and delivery tech

Afrezza approval: US FDA validation for Mannkind's drug and delivery tech

The US FDA approved Afrezza last weekend after deeming that the inhaled insulin drug and the dry...

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