21 CFR PART 11: Complete Manual for Compliance Success

FDA inspectors are ever increasing the number of inspections where they include Part 11 as a part of the scope or THE scope of the inspection. The trends and reports are showing that the FDA inspectors are focusing on electronic signatures and electronic records as more and more companies are implementing systems and technologies to […]

200+ followers. WOWWWWWW…

Hello Everyone, Today we have the pleasure of celebrating the fact that we have reached the milestone of 200+ followers on WordPress. Since we started this blog, we have had such a great time connecting with everyone.  we never expected to actually to connect with other people in the blogging community. we are so incredibly […]

FDA Requirements for ensuring Premarketing Clinical Trial Safety

The FDA has set out requirements for sponsors and organizations that carry out clinical trial to ensure premarketing clinical trial safety. This is a very vital requirement because this is the stage at which the database that goes into clinical trials is formed. Its integrity and safety is an important ingredient for assessing the risks […]

Regulations in the US and EU Dealing with Combination Products

Registering and maintaining combination products in the US and the EU is a bit tricky, because these are disparate markets that are governed by different sets of regulations which are independent of each other. So, any business that wants to market combination products into the US or the EU must be completely aware of the […]

Health Education England launches online workshop on improving digital readiness

Health Education England is launching an online workshop to gather views on digital readiness. The organisation is working in collaboration with Digital Health and innovation and crowdsourcing agency Clever Together on the online workshop, which forms part of the Building a Digital Ready Workforce programme. It will be launched on 22 November in partnership with […]

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 […]