MS could be reversed with existing allergy drug

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In a recent phase II clinical trial, an over-the-counter allergy drug was shown to improve nervous system function in patients with multiple sclerosis.

Multiple sclerosis (MS) is an autoimmune disease affecting more than 2.3 million people around the world. The condition attacks myelin, or the waxy coat around nerves, and compromises the nerves’ ability to transmit messages.

Over time, as the nerves’ function is steadily reduced, a range of symptoms — including problems with vision, muscle weakness, difficulty walking, and issues with balance and coordination — develop.

Current treatment focuses on preventing the immune system from causing further damage, and as it stands, no drugs can repair the damaged myelin.

Discovering a medication capable of rebuilding the damaged myelin would be a huge step forward. And according to the latest study, this may be just around the corner.

New MS drug on the horizon?

In 2014, studies carried out by Prof. Jonah R. Chan at the University of California, San Francisco showed that clemastine fumarate may be a candidate for the treatment of MS.

Because of the potential importance of the findings, the drug quickly progressed to clinical trials. This week, the results from a phase II clinical trial on clemastine fumarate are published in The Lancet.

Clemastine fumarate was first approved by the Food and Drug Administration (FDA) in 1977. It is an antihistamine medication for allergies and has been available over the counter since 1993. Its potential to treat MS is therefore as surprising as it is welcome.

According to principal investigator Dr. Ari Green, “To the best of our knowledge, this is the first time a therapy has been able to reverse deficits caused by MS. It’s not a cure, but it’s a first step toward restoring brain function to the millions who are affected by this chronic, debilitating disease.”

Read More: https://www.medicalnewstoday.com/articles/319732.php

Regulatory Filing Requirements and Compliance Processes for medical devices in Japan

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The market for medical devices in Japan is pretty huge. It ranks third in the world after the US and the EU. At just over $ 35 billion a year, which is characterized by an annual growth rate of 3-4 percent; it is far bigger than the markets in the neighborhood, such as China, Malaysia, Singapore and even Australia. Its market for medical devices is comparable to those of Europe and North America. Some of the reasons for this huge market are:

  • The aging population
  • The huge spending power of one of the world’s largest economies
  • The infusion of new technologies into the field of medical devices, which pushes up costs initially
  • The high proportion -nearly a quarter of the entire market -of imported medical devices, especially from the US, which introduce sophisticated, technology-driven products of higher price into the market

Japan’s classification system of medical devices, which classifies these products into Class I, Class II, Class III and Class IV; varies from that of the US or the EU. Adherence to Japanese Industrial Standards, which define industry-wide safety and performance requirements, is mandatory for medical devices.

In addition, the Japanese medical devices market has been undergoing a few major changes. Medical device manufacturers have to deal with strict new package insert requirements. The Marketing Authorization Holder (MAH) system, which deals with licensing rules, have changed, requiring a new MAH License category for In Vitro Diagnostic (IVD) devices. New changes have been made into several other aspects of medical devices. These include:

Medical device manufacturers have to also reckon with expanded scope of third party certifications, and comply with rules for Software as a Medical Device and for transferring pre-market certifications.

Full explanation of the regulatory requirements 

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All these factors make it very important for medical devices that want to enter the Japanese market, to get a thorough understanding of the regulatory requirements. Complete understanding of all these and more will be imparted at a two-day seminar from GlobalCompliancePanel, a leading provider of professional trainings for all the areas of regulatory compliance.

David R. Dills, Regulatory & Compliance Consultant with more than 24 years of hands-on experience and a proven track record within the FDA regulated industry; will be the Director of this seminar. David carries an extensive regulatory and compliance background with Class I/II/III and IVD devices, pharmaceutical operations, and manages activities within the global regulatory and compliance arenas.

 

Please log on to Regulatory Filing Requirements and Compliance Processes for medical devices in Japan to enroll for this highly valuable training session which will put the whole gamut of regulatory requirements for medical devices in Japan in perspective. This seminar has been pre-approved by RAPS as eligible for up to 12 credits towards a participant’s RAC recertification upon full completion.

 

Understanding how to streamline the regulatory process

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By attending this seminar, participants will be able to get a proper grasp of the entire registration and approval process in Japan. They will be able to identify and understand the major changes to medical device registration process in Japan. This will help them to streamline the medical device registration process, which will help them to obtain approval for their product in the most cost-effective and timely manner.

 

At this highly interactive session, the Director will let participants discuss their own device registration and approval process relative to their work-related responsibilities and handling submissions. This will be a very hands-on approach to helping them to review and discuss pain points, challenges and solutions.

David will cover the following areas at this seminar:

  • Which regulatory bodies in the Japanese government are responsible for medical device registration in Japan?
  • In Japan, are medical devices required to be registered before they can be sold?
  • What are the different regulatory classifications for medical devices?
  • What are the different application categories for medical device registration?
  • What does the registration pathway look like for each regulatory classification?
  • What are the document requirements for notification for the various classes of medical devices?
  • What are other requirements that are necessary for approval in addition to the device application?
  • Is local testing (type testing/sample testing) required for registration?
  • When are clinical studies required for registration?
  • Is approval in the Country of Origin required for registration?

 

To join us for more information, get in touch

 

 

 

Google’s Home Mini needed a software patch to stop some of them from recording everything

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Categorize this under “one of the worst possible PR nightmares for a Google smart speaker.” According to Artem Russakovskii at Android Police, the Google Home Mini he was reviewing was randomly and near-constantly recording sounds in his home and transmitting them to Google. The company acknowledged the problem and is issuing a software update to resolve the issue, which appears to boil down to a failure of the touch sensor on the top.

Smart speakers like the Google Home Mini are designed to only listen for a specific wake word — in this case it’s “Hey Google” or “Ok Google.” Only then do their microphones record what you’re saying it, transmit it to the cloud, and try to answer your question. But there is usually a way to just hit a button and ask the embedded assistant a question. On the Mini, it’s holding your finger down on the top of it.

That seems to be the rub (pardon the pun) with Russakovskii’s Mini: it thought that somebody was holding its finger down on the top and so was randomly activating and recording. The good news is that the lights turned on to indicate it was listening, but the bad news is that it didn’t make an audible tone, so it took a trip through the Home’s search history to discover the error.

To Google’s credit, it seems to have scrambled the engineering jets to figure out the issue and create a fix. The fix, though, is removing a feature from the Mini. Google has altered the software so a simple touch won’t activate the Assistant, you have to say the wake word instead. Here’s Google’s statement about the issue.

“We learned of an issue impacting a small number of Google Home Mini devices that could cause the touch mechanism to behave incorrectly. We rolled out an update on October 7 to mitigate the issue. If you’re still having issues, please feel free to contact Google Support at 1-855-971-9121 to get a replacement Google Home Mini.”

Google has also posted a help article about the issue, characterizing the affected units as “early release Google Home Mini device at recent Made by Google events” and noting that it won’t affect preordered units sold at retail.

Read More: https://www.theverge.com/2017/10/10/16456050/google-home-mini-always-recording-bug

Eight deaths due to ‘seasonal flu’ in Oman, health guidance issued

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Muscat: The number of Influenza cases has dropped by almost a quarter compared to 2016, but the Ministry of Health has warned residents to

be vigilant as flu season approaches.

According to the latest report by the MoH, deaths as a result of influenza have reduced over the past three years, with 2017 season seeing eight cases of deaths so far compared to 2015 which recorded 25 deaths.

As a semi-tropical country, seasonal influenza viruses continue to appear throughout the year in the sultanate. The virus starts in early September and can continue until mid-May.

“In 2017, there were 952 cases until the tenth of October of influenza while 2016 saw 1492 cases of influenza,” the ministry said in a statement.

“The Sultanate has recorded 25 cases of deaths in 2015, six cases of deaths in 2016, and eight deaths in 2017, all linked to the flu and most of those cases were among the groups most at risk of high risk of complications of influenza. Despite the high number of cases, it is still within the normal range compared to previous years,” added the ministry.

 

Read More: http://snip.ly/d2kxu#http://timesofoman.com/article/119152/Oman/Omanisation/Eight-deaths-due-to-%27seasonal-flu%27-in-Oman-health-guidance-issued

21 CFR Part 11 compliance requirements for software validation and SaaS/Cloud

 

21 CFR Part 11 compliance requirements for software validation 1.jpgSoftware as a Service, SaaS, is a way by which applications are delivered over the Net. It provides Software as a Service using just the Internet, and hence the name. SaaS applications are known by varied names. On-demand software, hosted software, and web-based software are some of these.

Where SaaS differs as a method of delivering applications is that there is no need to install and maintain software at or from the client’s location. All that is needed to access all these is an Internet connection. The provider can run SaaS applications on his own servers. With the provider taking over the responsibility of managing all aspects of the application, such as making it available and secure, and also for its performance; the client is spared the hassle of having to manage unfamiliar and often complex software and hardware.

Given this novelty and ease of its application; SaaS has grown into a huge market. Its US market was estimated at just over $ 10 billion in 2011. In the next couple of years, the global SaaS market is set to grow to around $ 120 billion. Experts put its speculated CAGR at between 18 and 24 percent and expect SaaS to make up more than one fifth of all software services by 2019.

Now, the difficult part of SaaS

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All these bright spots about SaaS notwithstanding; it comes with a few hiccups. Given its nature, most SaaS providers outsource their resources to cut costs. This makes them very vulnerable, since most regulations, such as 21 CFR Part 11, apply only to the provider, and give little by way of safeguards to the vendor. With very less vigilance and scrutiny on the vendor; the onus of ensuring compliance for both infrastructure qualification and Computer System Validation lies with the regulated company, for it is they who have to show compliance with the regulations and prevent issues relating to availability, performance and protection of data.  In other words, while the actual work of SaaS is carried on by the vendor; it is the client who has to ensure compliance with regulations arising out of 21 CFR Part 11.

Since on paper it is the regulated provider to whom all the regulations apply; it becomes the target of FDA inspections on software validation. They have to show compliance with these regulations set out in 21 CFR Part 11 and other regulations such as Annex 11 if they have to avoid FDA actions such as Warning Letters and 483’s. There is thus a major need for regulated companies, software vendors and SaaS/cloud providers to show compliance with 21 CFR Part 11. This is the only way to avoid legal and other issues associated with noncompliance.

The ways of staying compliant

21 CFR Part 11 compliance requirements for software validation

This is what a two-day seminar that is being organized by GlobalCompliancePanel, a highly regarded provider of professional trainings for the regulatory industries, will offer. This seminar will explain in-depth how regulated companies, software vendors and SaaS or cloud providers can ensure compliance and safeguard and enhance their reputation as trustworthy providers

David Nettleton, who is an industry leader, author, and teacher for 21 CFR Part 11, Annex 11, HIPAA, software validation, and Computer System Validation, will be the Director of this seminar.

Please register for this webinar by visiting 21 CFR Part 11 compliance requirements for software validation and SaaS/Cloud. This seminar has been pre-approved by RAPS as eligible for up to 12 credits towards a participant’s RAC recertification upon full completion.

An explanation of proven techniques

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Over the two days of learning at this seminar, David will demonstrate proven techniques for cutting costs associated with the implementation, usage, and maintenance of computer systems in regulated environments. In doing this, David will address the latest computer system industry standards for data security, data transfer, audit trails, electronic records and signatures, software validation, and Computer System Validation.

With the FDA performing both GxP and Part 11 inspections; the EMA has released an updated Annex 11 regulation that expands Part 11 requirements. Companies must update their systems and processes to maintain compliance. This aspect will be explained at this seminar. The Director will offer participants an understanding of the specific requirements associated with local and SaaS/cloud hosting solutions.

Validation in several specialized areas

The regulatory agencies require almost every computerized system used in laboratory, clinical, manufacturing settings and in the quality process to be validated. David will show the ways by which they can do this while decreasing software implementation time and lowering costs using a 10-step risk-based approach to Computer System Validation. He will review recent FDA inspection trends and discuss how to streamline document authoring, revision, review, and approval.

This seminar is of high value to anyone who uses computer systems to perform their job functions in the regulatory, clinical and IT areas of health care, clinical trial, biopharmaceutical, and medical device sectors. Software vendors, auditors and quality staff involved in GxP applications will also derive high value from this seminar.

 

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Drugstore stocks tumble as Amazon considers selling prescription drugs online

Drugstore stocks tumble as Amazon considers selling prescription drugs online

Shares of drugmakers dropped in midday trading Friday after CNBC reported Amazon is in the final stages of considering an entrance into selling drug prescriptions.

Walgreens, Rite Aid and CVS Health stocks each slipped 4 percent or more as investors worried Amazon may disrupt the traditional distributors’ hold on the drug prescription market.

Amazon will decide before Thanksgiving whether to move into selling prescription drugs online, according to a source and an email from Amazon viewed by CNBC.

Amazon typically spends years researching opportunities before it telegraphs its intentions. The opportunity to sell drugs online is alluring given its market size – analysts have estimated the U.S. prescription

 

Read More: http://snip.ly/j7tf0#https://www.cnbc.com/2017/10/06/drugstore-stocks-tumble-as-amazon-considers-selling-prescription-drugs-online.html

Are any weight loss supplements considered safe?

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Every year, millions of Americans go after this same goal, some successful and others not so much. To attain their goals, they may choose from the over-abundance of diets and exercise programs available, and some turn to weight loss supplements as well.

While you shouldn’t rely on supplements to do all the work for you, there are a few that can be used safely to boost your weight loss efforts.

Before you decide on weight loss supplements, though, you should consider the health effects carefully. Always check with your doctor first to be sure about safety, and remember that these pills are supplements. They’re meant to be used alongside healthy eating habits and proper exercise.

DO YOU HAVE LIVER DAMAGE?

Again, never use supplements by themselves to lose weight. Some people turn to weight loss pills so that they can continue an unhealthy lifestyle while staying thin.

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 This dangerous mentality could lead to frightening situations like addiction, overdose or death. Also, brands that claim to shed weight without any effort may contain ingredients that will do you more harm than good. If you have any doubt about a supplement, stay away.

Weight Loss Supplements that Work

Just like any other medication, weight loss supplements have both benefits and side effects. When choosing a supplement, you should know all the possible effects and consider them in light of your own health history. Especially if you have other health issues, you should check carefully for ingredients that may trigger or worsen your symptoms.

Let’s look at 3 supplements that you could consider adding to your weight loss program:

1. Green Tea Extract

Green tea has long been known for its health benefits, mainly because the drink is high in antioxidants. In particular, green tea contains large amounts of polyphenol antioxidants called catechins, which may help reduce oxidative stress.

For weight loss, studies have shown that green tea extract can help boost the metabolism. Researchers think that the combination of antioxidants and caffeine work together to accomplish this goal.

 

Read More: http://snip.ly/1alkc#http://www.foxnews.com/health/2017/10/06/are-any-weight-loss-supplements-considered-safe.html