6 Ways To Start Improving Your Gut Health Today

Brooke Lark / Unsplash

Considering the rapid rise in kombucha, sauerkraut and probiotic products, it’s pretty clear gut health is on everyone’s minds. And with good reason — more and more research is emerging showing just how important good gut health is for overall wellbeing.

“Having a healthy gut is so important,” accredited practising dietitian and sports dietitian Chloe McLeod told HuffPost Australia.

“It’s linked to a number of different medical conditions. When your gut isn’t healthy it can have an impact on mental health, weight, mood and a number of other digestive disorders. Keeping your gut nice and healthy can help keep the rest of your body healthy.”

Brooke Lark / Unsplash

How do you know if you have good gut health?

“Signs of good gut health include not getting bloating, gas, diarrhoea and constipation,” McLeod said.

“You find you feel better in general — better mood, more energy, a healthy weight and not feeling fatigued. These are all more pronounced when your gut is healthier.”

How do you know if you have bad gut health?

“If you have poor gut health you may have loose, unformed stools, or you’re really constipated, maybe your faeces are foul smelling, you feel gassy, feel foggy headed or have poor mood. These are some of the most common signs,” McLeod explained.

What can negatively affect gut health?

There are a number of diet and lifestyle-related factors which can impact the health of your gut.

“From a nutrition perspective, factors that negatively impact gut health include poor diet, alcohol and having a high fat intake,” McLeod said.

“Also, if you are someone with food intolerances, any large quantity of those trigger foods can have a negative effect on your gut health.

“Being highly stressed all the time impacts cortisol levels, and stress can be a factor for some people. Some medications can also affect gut health.”

 

Read More: http://snip.ly/r70uc#http://www.huffingtonpost.com.au/2017/09/24/6-ways-to-start-improving-your-gut-health-today_a_23218661/

FDA Finalizes Guidance on Interoperable Medical Devices

On September 6, 2017, FDA finalized a guidance document entitled “Design Considerations and Pre-Market Submission Recommendations for Interoperable Medical Devices” (“Final Guidance”). In the Final Guidance, the agency outlines design considerations for manufacturers when developing interoperable medical devices, as well as recommendations about information to include in premarket submissions and device labeling. Interoperability of devices can encourage the availability and sharing of information across systems, even when products from different manufacturers are used. A draft of this guidance was issued on January 26, 2016.

The Final Guidance defines “interoperable medical devices” as medical devices “that have the ability to exchange and use information through an electronic interface with another medical/non-medical product, system, or device.” These functions can consist of a one-way data transmission to another device or product, or more complex interactions in which command and control is exercised over another device. An “electronic interface” is defined as the medium by which systems communicate with each other, and includes both the type of connection and the information content.

According to the Final Guidance, the agency considers the management of risks associated with an electronic interface incorporated into a medical device to be part of a comprehensive quality system under 21 C.F.R. Part 820. Manufacturers of interoperable medical devices should perform a risk analysis and conduct appropriate testing addressing the risks associated with interoperability, the anticipated users, reasonably foreseeable misuse, and reasonably foreseeable combinations of events that can result in a hazardous situation. In particular, the Final Guidance identifies the following considerations that manufacturers should take into account and “appropriately tailor[]” to the device’s interface technology, intended use, and use environments

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FDA Breaks New Ground With First Approved Gene Therapy for Cancer

FDA Breaks New Ground With First Approved Gene Therapy for Cancer.jpg

When oncologist Dr. Carl June heard the Food and Drug Administration’s decision to bring the first gene therapy to market in the US, he pinched himself, hard.

“It was so improbable that this would ever be a commercially approved therapy,” he said, voice breaking with emotion.

June was referring to a revolutionary cancer therapy that he helped bring from lab bench to market. Co-developed with the drug giant Novartis, the therapy, CAR-T, genetically alters a patient’s own immune cells to target and destroy cancer cells.

Recently, in a historic decision, the FDA threw their support behind Kymriah (tisagenlecleucel), a “living drug” that is designed to treat blood and bone marrow cancer in children that, even with aggressive chemotherapy, is often lethal.

An entire process rather than a packaged pill, the therapy harvests a patient’s own immune cells—T cells that patrol and destroy abnormal cells—retrains them with extra bits of genetic code, and turns them into torpedoes aimed at cancerous cells once reintroduced into patients’ bodies.

“We’re entering a new frontier in medical innovation with the ability to reprogram a patient’s own cells to attack a deadly cancer,” said FDA Commissioner Dr. Scott Gottlieb in a statement, adding that the therapy is “the first gene therapy available in the United States.”

Read More: http://snip.ly/bunjk#http://www.philly.com/philly/business/fda-advisors-give-a-thumbs-up-to-glaxosmithklines-shingles-vaccine-20170913.html

Upcoming FDA FSMA Rules of Human and Animal Foods

The process of finalizing new food safety rules by the U.S. Food and Drug Administration (FDA) is underway. The accent of these upcoming FDA FSMA rules on the sanitary transportation of human and animal foods is the ways by which scientific and safe transportation and logistics involved in food transportation can be bettered. The FDA is required to establish rules for improving, auditing and enforcing new rules relating to food transportation. Congressional instructions have been issued for ensuring the establishment of these rules.

These are the aspects of food transportation that come under the ambit of these new FSMA Rules:

–       Foods not completely enclosed by a container

–       Preventing and reducing adulteration and risk

–       Training and certification of personnel for this purpose

–       Food inspection and collection of data

–       Maintaining compliance and reporting about its evidence.

Get trained on how to do this right

Since the FDA FSMA Rules on the Sanitary Transportation of Human and Animal Foods apply to organizations that work in food transportation; these organizations have to ensure proper adherence to these rules. To do this, they need to first understand the rules and also know what it takes implement them. A seminar being organized by GlobalCompliancePanel, a leading provider of professional trainings for all the areas of regulatory compliance will offer this learning.

John Ryan, President, TransCert, QualityInFoodSafety, RyanSystems, is the Director of this two-day seminar. He will offer understanding and insights into the way the new Rules from the FDA apply to players involved in the transportation of human and animal foods.

The Director will also impart complete understanding of the ways by which to establish the right temperature monitoring, sanitation, container test and traceability, training and data reporting procedures and review the same. This seminar will also offer an understanding of the legal requirements of food transportation and how to develop a company plan that meets the expectations and requirements of both its customers and the FDA.

You can register for this seminar by visiting Upcoming FDA FSMA Rules on the Sanitary Transportation of Human and Animal Foods This seminar has been pre-approved by RAPS as eligible for up to 12 credits towards a participant’s RAC recertification upon full completion

Technological aspects of FDA FSMA Rules on the Sanitary Transportation of Human and Animal Foods

Dr. Ryan will offer insights into all the aspects of the FDA FSMA Rules on the Sanitary Transportation of Human and Animal Foods and help participants understand how to comply with them. In the course of this learning, he will cover the technological aspects of food transportation, which are gaining importance lately. These include new low cost GPS enabled traceability and temperature monitoring technology, EPA approved container sanitizers, washout technologies, temperature maintenance equipment, and food residue and bio-contaminant testing. Dr. Ryan will examine the close relationship these technologies have with the FDA FSMA Rules on the Sanitary Transportation of Human and Animal Foods.

Dr. Ryan’s assessment of the future of transportation food safety vis-à-vis new and evolving technologies will be peppered with references to upcoming technology providers. He will provide the participants of this seminar with Internet links that lead to more detailed information on the same.

Those in food supply chain logistics and food safety and security personnel whose primary responsibilities include management, sanitation, quality and operations; will find this seminar highly useful.  It will also be useful for personnel that handle incoming and outgoing food shipments, maintaining transportation equipment and tools, and purchasing or selling.

Dr. Ryan has the following agenda for this seminar:

o   Review of the FDA’s proposed rules on the sanitary transportation of human and animal foods

o   Review of other international transportation food safety guidance and laws

o   The meaning of adulteration

o   Review of Standards

  • Management
  • Sanitation
  • Hazard analysis risk-based preventive controls
  • Traceability and temperature monitoring
  • Training

o  GAP analysis

o  Learning what happens during cold chain food transportation through all processes

  • Farms
  • Air
  • Ship
  • Truck
  • Trays and Bins

o  Data, logs, forms and electronic record keeping

o  Shipment cargo theft, security and recall

o  Issues facing food importers and those buying from them

o  Return on investment (ROI) and marketing advantages

o  Future technologies (trans-oceanic, satellite, etc.)

o  Establishing an initial plan to implement your auditable system

  • Choosing which standards apply to your company
  • Flowcharting your process
  • Determining when and how you will perform a GAP analysis
  • Listing new procedures for your operation
  • Selecting and assigning key personnel.