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November 2017 Blog Posts (39)

An understanding of Federal-Wide Assurances

The Federal-Wide Assurance (FWA) is an assurance given by an institution that is carrying out NIH-funded studies. Through this written assurance, which is required to be filed with the Office for Human Research Protections (OHRP); the institution commits itself to compliance with the terms of requirements set out in the HHS Protection of Human Subjects regulations at 45 CFR part 46. It is the only type of assurance that the OHRP accepts and approves.

The FWA must clearly outline the…

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Added by Roger Steven on November 10, 2017 at 6:35am — No Comments

Philadelphia woman tries passing fake scripts at Palmer pharmacy

Philadelphia woman tries passing fake scripts at Palmer pharmacy

PALMER TWP., Pa. – A Philadelphia woman is facing fraud charges after she allegedly arrived at a Northampton County pharmacy Wednesday night with fake prescriptions for more than 200 pills.

Police arrested Samantha M. Brown at a Palmer Township Rite Aid with fraudulent prescriptions for Oxycodone, Alprazolam and Flexiril. The 25-year-old now faces three felony counts of trying to acquire a controlled substance. District Judge James Narlesky…

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Added by John Robinson on November 10, 2017 at 4:54am — No Comments

Thousands of drugs at risk if no Brexit deal, European pharmaceutical companies warn

Brexit threatens the free flow of these goods, given stringent medicine regulations that may require the retesting of drugs shipped across borders in the absence of an agreed trading arrangement.

Thousands of d.jpg

Supplies of thousands of medicines are at risk of disruption if Britain leaves the European Union without a trade deal, European pharmaceutical companies warned on Thursday. More than 2,600 drugs have some stage of manufacture in…

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Added by John Robinson on November 9, 2017 at 5:48am — No Comments

The ISO 13485: 2016

The ISO 134855

The ISO 13485, which is the ISO’s global medical device standard; was upgraded significantly in 2016. This upgrade was carried out primarily to help the standard keep up with the changes that have taken place in the industry in about the decade and a half since the previous standard was brought into effect in 2003.…

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Added by John Robinson on November 9, 2017 at 5:44am — No Comments

Lonza news Tolvaptan identified as a treatment for autosomal dominant polycystic kidney disease

A phase 3 trial studying the effects of tolvaptan has found that the drug slowed the rate of decline in kidney function in patients with polycystic kidney disease…

Tolvaptan identified

A phase 3 trial studying the effects of tolvaptan has found that the drug slowed the rate of decline in kidney function in patients with the most common form of…

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Added by John Robinson on November 9, 2017 at 5:42am — No Comments

Murj wants to give data collection from implantable medical devices an upgrade

Murj, a new company backed by $4.5 million in new venture financing, is looking to make data collection from implantable heart monitoring and management devices easier and more manageable.

The company was founded by a former Medtronic sales rep who’d previously worked as a product manager on Apple’s iPads. After a few years in sales, Murj founder Todd…

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Added by John Robinson on November 8, 2017 at 5:39am — No Comments

Testing GxP system that is FDA-compliant

Testing GxP system that is FDA-compliant

Process validation is the method of using data from stages ranging from the process design stage to production, to ensure that the process that is being used can deliver consistently high-quality products. Companies that come under the life sciences must comply with GxP regulations to ensure that their processes meet the regulatory guidelines to be GxP compliant.…

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Added by John Robinson on November 8, 2017 at 5:37am — No Comments

Study finds link between increased brain glucose levels and Alzheimer’s

A new study published yesterday in Alzheimer’s & Dementia: the Journal of the Alzheimer’s Association, found a link for the first time between abnormalities in the mechanism of glucose breakdown in the brain and the severity of tangles and amyloid plaques in the brain, as well as the commencement of visible symptoms of Alzheimer’s disease.…

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Added by John Robinson on November 8, 2017 at 5:33am — No Comments

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 devic…

Understanding the infinite area of medical device compliance 1.png 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…

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Added by John Robinson on November 7, 2017 at 5:06am — No Comments

Microbiome, Diet, Health, and Disease: Policy Needs to Move Forward

Microbiome, Diet, Health, and Disease.jpg

This article covers policy needs concerning the rapidly evolving field of microbiome and diets with respect to health and disease. It captures some key outcomes of a multi-stakeholder dialogue (Brussels, May 2016), spearheaded by a joint effort of the Organisation for Economic Co-operation and Development (OECD) and the Department of Economy, Science and Innovation of the Flemish Government (Belgium), to help design and/or interpret regulatory…

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Added by John Robinson on November 7, 2017 at 5:04am — No Comments

GSK therapy for multiple myeloma receives breakthrough therapy designation

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Added by John Robinson on November 7, 2017 at 5:00am — No Comments

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 Adam Fleming 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

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