Understanding the infinite area of medical device compliance

With a seemingly unlimited number of products coming under the broad umbrella of medical devices; it is but natural that regulations for these products are equally expansive. This makes medical devices compliance an extremely enormous and broad topic. With the FDA being the sole regulator for this very vast area; it comes up with regulations, […]

GMP and Regulatory Expectations for Early IND Products

 What the FDA’s recent guidance documents covering GMP requirements for Phase I products have done is to significantly reduce a few of the complexities that early phase products are typically against. These guidance documents are in addition to those that cover the CMC sections for IND submissions at Phase I. These new guidelines appear to […]

Video of father comforting newborn son receiving his first vaccines goes viral

On October 26, first-time father Antwon Lee took his two-month-old son Debias King to get his first vaccinations. Lee, 29, said he was very nervous for the appointment, telling People Magazine that he “felt kind of scared a little bit,” as he knew the child was “going to go through some pain.” Before the visit, […]

IT’S A NO BRAINER! Action needed to stop children being exposed to chemicals that harm their brain development!

A report published today by CHEM Trust highlights how chemicals in food and consumer products used in homes, schools and offices could harm brain development in children. The impacts – which may include ADHD and lower IQ – are avoidable and can prevent children reaching their full potential says CHEM Trust, in No Brainer: The […]

The science of Sad: understanding the causes of ‘winter depression’

For many of us in the UK, the annual ritual of putting the clocks back for daylight saving time can be accompanied by a distinct feeling of winter blues as autumn well and truly beds in. This might be felt as a lack of energy, reduced enjoyment in activities and a need for more sleep […]

Second Death From Flesh-Eating-Bacteria Infection After Hurricane Harvey Is Reported

  A 31-year-old man who helped to repair homes in Galveston, Texas after flooding caused by Hurricane Harvey was recently diagnosed with flesh-eating bacteria and died on October 16th after being admitted to a hospital on October 10th, according to a statement released by health officials in Galveston on Monday. He is the second person […]

Heart surgery survival chances ‘better in the afternoon’

Open heart surgery appears to be safer in the afternoon because of the body’s internal clock, scientists have said. The body clock – or circadian rhythm – is the reason we want to sleep at night, but it also drives huge changes in the way our bodies work. The research, published in the Lancet, suggests […]

Precision medicine: From ‘one-size-fits-all’ to personalized healthcare

Imagine a future in which, rather than using symptoms to identify a disease, your genes, metabolism, and gut microbiome inform how your individual health is managed. This is the vision of precision medicine. Traditional medicine uses symptoms to diagnose diseases, and drugs to treat these symptoms. But precision medicine aims to turn this concept on its […]

8 Tough Questions Every CISO Should Be Ready to Answer

When a major security incident, such as the recent massive Equifax data breach, grabs headlines, CEOs start asking more questions about data security. See Also: Addressing the Identity Risk Factor in the Age of ‘Need It Now’ CISOs need to be thinking about their answers to critical questions the CEO is likely to pose. Information […]

Ensuring the accuracy, reliability and consistency of analytical data in laboratories

The basic reason for which analytical methods and procedures need to be validated is to ensure that analytical data have consistency, accuracy and reliability. This becomes possible when laboratories employ proper scientific methods and procedures and validate analytical methods and procedures. This is the only means to ensure that the analytical data are reliable, consistent […]