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All Blog Posts (1,246)

Australia’s health watchdog accused of ‘too close’ relationship with industry

Australia’s drug and medical device watchdog, the Therapeutic Goods Administration, needs a complete overhaul to distance it from the health industry and allow consumers to sue it for negligence, say academics and consumer advocates after the regulator quietly announced moves to classify all pelvic mesh devices high risk after years of controversy.

“The current regulatory framework is a complete bypass of the interests of consumers. They don’t have a stake…

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Added by John Robinson on November 6, 2017 at 5:20am — No Comments

Project Management is important for non-Project Managers, too

Project Management is important for non-Project Managers, too

A few skills need to be imbibed by professionals, even if they are out of their domains or area of expertise. This is because when it comes to handling crunch situations; one cannot expect a manager to…

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Added by John Robinson on November 6, 2017 at 5:17am — No Comments

Orkambi Reduces Main Biomarker of CF, Vertex Says in Updated Results on Four Therapies

Orkambi Reduces

Orkambi (lumacaftor/ivacaftor) reduced levels of the main biomarker of the lung disease cystic fibrosis and improved the nutritional status of children with the condition, according to a Phase 3 clinical trial.

The results were part of a recent update that Vertex…

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Added by John Robinson on November 3, 2017 at 6:25am — No Comments

Statins ‘should be given to children with heart risks before the age of 10’

Statins 'should be given

Statins should be given to thousands of children by the age of 10 under radical new NHS guidance.

GPs are being urged to identify those who have an inherited risk of high cholesterol, amid warnings that the vast majority of cases are going undetected.

Estimates suggest up to 260,000 people –…

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Added by John Robinson on November 3, 2017 at 6:24am — No Comments

GMP and Regulatory Expectations for Early IND Products

 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…

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Added by John Robinson on November 3, 2017 at 6:22am — No Comments

Companies continue to increase transparency of external audit oversight

More companies are providing investors and other stakeholders with information about audit committee oversight of external auditors, according to the latest edition of the Audit Committee Transparency Barometer, an annual report released Wednesday by the Center for Audit Quality (CAQ) and Audit Analytics.

“For the fourth year in a row, audit committees have continued to…

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Added by Compliance4all on November 3, 2017 at 5:49am — No Comments

Process Development and Validation rest on the right Design of Experiments and Statistical Process Control

Design of Experiments and Statistical Process Control1.jpg

The application of DOE and SPC to the development, design and monitoring of manufacturing and testing requires the use of procedures. Why? It is because in a recent guidance document on Process Validation, the FDA has named the Quality Unit as being responsible in the review and interpretation of DOE and SPC studies.

The Quality…

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Added by John Robinson on November 2, 2017 at 6:49am — No Comments

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

Video of father comforting.jpg

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…

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Added by John Robinson on November 2, 2017 at 6:45am — No Comments

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…

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Added by John Robinson on October 31, 2017 at 6:24am — No Comments

Putting an effective complaint and recall management system in place

Putting an effective complaint and recall management system in place1

Complaints very strongly show a company how its products or services are perceived where it matters the most -in the customer’s mind. Complaint handling is one of the key indicators of how seriously a business takes its customers’ point of view. Complaints are to be expected from about any product; but their importance is all the more felt in an area like medical devices, because these products can affect the very life of…

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Added by John Robinson on October 31, 2017 at 6:22am — No Comments

Introduction to Design Controls in medical devices

Design Control for medical devices can be understood as an integrated set of verifiable and demonstrable steps and practices undertaken by the manufacturers of these devices. Design Control for medical devices comprises a set of steps relating to the quality and consistency of medical devices, whose manufacturers take to ensure that:

  1. There is safety in the medical device under manufacture
  2. All the recommended and required steps and procedures that go into manufacturing…
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Added by Compliance4all on October 31, 2017 at 6:08am — No Comments

HIPAA and the role of the Security Officer

Security Officers or Compliance Officers have their task cut out when it comes to HIPAA implementation. With the changes taking place at the Health and Human Services (HHS) in relation to HIPAA enforcement; both Covered Entities and Business Associates need to insulate themselves from being vulnerable to audit risk. Any small letup will allow individuals whose PHI has been wrongfully disclosed due to bad IT or internal…

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Added by Roger Steven on October 30, 2017 at 7:50am — No Comments

Joe Stuntz on cybersecurity and One World Identity

Joe Stuntz was most recently the Policy Lead for the White House Office of Management and Budget (OMB) Cyber and National Security unit, now he works with One World Identity. We spoke with Stuntz about cybersecurity threats and solutions.

In October 2017, One World Identity, an…

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Added by Compliance4all on October 30, 2017 at 6:47am — No Comments

The use of Applied Statistics for FDA Process Validation

Why you Should be Worried about HIPAA The use of Applied Statistics for FDA Process Validation is considered a matter of very high importance in the pharmaceutical industry. The FDA’s guidance for the industry, which it called “Process Validation: General Principles and Practices”, was set up in 2011. This guideline sets the framework for Process Validation in the pharmaceutical industry. The FDA prescribes a three-stage process that any organization in the pharmaceutical industry has to set…

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Added by John Robinson on October 30, 2017 at 6:32am — No Comments

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

The science of Sad

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 than normal. But for…

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Added by John Robinson on October 30, 2017 at 6:28am — No Comments

Administering injectable and oral diabetic medications among cardiac patients

Hypertension is the silent killer of our times. Over thirty million Americans -one eleventh of the entire country’s population -suffer from this condition. It is rightly termed the silent killer because not only does it not show obvious symptoms; it works silently against the system when it is present. Neglected hypertension is a sure cause for strokes and heart attacks.

There is a highly undesirable, but strong and almost irrefutable link between cardiovascular disease (CVD) and…

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Added by Roger Steven on October 27, 2017 at 7:17am — No Comments

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 to die from…

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Added by John Robinson on October 27, 2017 at 7:03am — No Comments

Heart surgery survival chances ‘better in the afternoon’

Heart surgery.jpg

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,…

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Added by John Robinson on October 27, 2017 at 7:00am — No Comments

Misinterpretation of closed Data when Treated with “Normal” Statistical Methods

Geology is among the many branches of science in which compositional data (CoDa) arise naturally. In branches such as geochemistry, compositional data seem to occur typically, when one normalizes raw data or when one obtains the output from a constrained estimation procedure, such as percentages, ppm, ppb, molar concentrations,…

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Added by Compliance4all on October 27, 2017 at 6:07am — No Comments

Forbes Talks Taxes, Healthcare in Address to Students

Forbes Talks Taxes, Healthcare in Address to Students

As Republicans struggle to score a legislative win on taxes, Steve Forbes dismissed fears that the American economy is doomed to slow economic growth or secular stagnation as “preposterous.”

Forbes, the chairman and editor-in-chief of Forbes Media and former Republican presidential candidate, blamed the current economic rut on correctable policy errors in a lecture sponsored by the Cornell Republicans on Wednesday.

The real source of…

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Added by John Robinson on October 26, 2017 at 6:36am — No Comments

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