Professionals Involved in The FDA’s Tougher Import Rules for 2017

Tougher Import Rules for FDA Imports in 2017

Of late, the FDA and the Customs and Border Patrol Service (CBP) have become increasingly agile, smart, sophisticated and demanding when it comes to the submission of information and adherence to government procedures from importing firms. The FDA and the CBP can delay, detain or refuse shipments of firms do not properly execute an import and export program.

The CBP’s new Automated Commercial Environment (ACE) computer program has carried out several changes to the process of import logistics and information reporting for FDA regulated products. The alternatives to noncompliance with the requirements of the ACE program: A shipment may be stopped before it is even loaded at the foreign port. Ships that refuse to or fail to use the ACE program also carry a fine of up to $10,000 for every offense.

Or, when the FDA detains a company’s product; it will begin an expensive and time-consuming legal process. Since the agency expects companies to have the import coding information accurate and up-to-date; companies that do not have a clear understanding of the automated and human review process can expect to have their shipments detained.

One more area that poses a challenge for importers is when the FDA decides that they should bring the products back to the port of entry after they received a release but cannot locate the product that has been sold. In such a scenario, companies that go through this process attract a fine that is three times the value of the shipment. This is in addition to the other adverse legal concerns and strategies that are attached to this action. Overall, the costs of not complying with the FDA’s guidelines on imports can be very high and can carry very expensive consequences for importing companies.

There are positives, too

The FDA_s Tougher Import Rules for 20171

However, not all is lost. The FDA is implementing the Voluntary Qualification Importer Program under the FDA Food Safety and Modernization Act. Aimed at incentivizing importers who instill a high degree of confidence about the quality of food they import; the nub of this plan is that it establishes an FDA-supervised, fee-based program that expedites the review and importation of foods from importers who can show a heightened level of control over the safety and supply chain aspects of the imported food items.

Another convenience that the FDA offers is export certificates. Obtainable for a modest fee; these certificates may give an importer a competitive advantage in foreign markets. An FDA export certificate is actually a requirement by a few foreign governments.

Full learning on the FDA’s new import rules for 2017

The FDA_s Tougher Import Rules for 20173

All the aspects of the new FDA import rules will be taught at a highly absorbing two-day seminar that GlobalCompliancePanel, a leading provider of professional trainings for all the areas of regulatory compliance, is organizing.

Casper Uldriks, an ex-FDA Expert and former Associate Center Director of CDRH, Olsson, who has served as a senior manager in the Office of Compliance and an Associate Center Director for the Center for Devices and Radiological Health, where he developed enforcement actions and participated in the implementation of new statutory requirements for FDA; will be the speaker. to enroll for this course, please visit Professionals Involved in The FDA’s Tougher Import Rules for 2017. This course has been pre-approved by RAPS as eligible for up to 12 credits towards a participant’s RAC recertification upon full completion.

Casper will impart learning on all these topics and on the ways by which to avoid these and related common problems that can become terribly expensive when a proper strategy and plan for dealing with them are not implemented. Importers need to put in place an established and effective business planning, whose ways will be shown at this seminar. A bonus of this course is that the speaker will also include tips on how to understand FDA’s thinking and offer anecdotal examples of FDA’s import program idiosyncrasies. He will also explain how to deal with common problems, such as returns for repair, importing QC samples, and investigational products.

Are you ready to join us to Keep Growing Up

 

 

 

 

A step towards better health care

 

step towardsToday, we live in an era of customization. Increasingly, customers can modify a product’s appearance, features, or content according to their unique needs or desires. Often, even the news we see in our newsfeeds is customized based off our preferences.

Why, then, are so many aspects of the health care industry still one-size-fits-all?

As doctors, we’ve seen firsthand how this can negatively impact patients who require more individualized care. One particular example is a practice known as “step therapy” or “fail first.”

Now, when patients visit their doctors for a prescription, the treatments they are prescribed are typically based on a variety of personal factors. These factors include their health history, underlying symptoms, and their doctor’s long-term understanding of their condition, such as whether they have already tried certain drugs under a different health insurance plan, if they have other medical conditions that might interfere with the drug’s effect, whether certain drug’s side effects will affect the patient’s ability to perform their job, or if the patient would prefer a drug that has a different ingestion method or dosage form. Treatment plans need to be based on the individual’s needs, and their doctors’ medical expertise and first-hand knowledge of their patients’ overall health.

 However, far too often, what happens next is the problem. When a patient goes to the pharmacy to fill their prescription, they may be informed that their physician-prescribed medicine will not be covered unless the patient first proves that another medication-one of the insurer’s choosing, not their doctor-will not work for them.

In such a case as this, failure is not only an option, it is the only option before getting appropriate treatment.

Under the current system, patients are left with a limited set of options: either try a medication that is not what their doctor recommended for their condition, or pay out of pocket for the treatment they need. For many people, that’s not a choice at all. They are simply forced to fail on a medication other than what their doctor prescribed.

Read More: http://snip.ly/3h8ax#http://thehill.com/blogs/congress-blog/healthcare/356083-a-step-towards-better-health-care

Flu vaccine: NHS patients wanted to test ‘universal’ jab

Flu vaccine NHS pa

Researchers are seeking about 500 NHS patients to try out a new “universal” vaccine against seasonal flu.

The experimental vaccine works differently from the one currently available, which has to be remade each year based on a “best guess” of what type of flu is likely to be about.

The new jab targets part of the virus that does not change each year.

This means the vaccine should work against human, bird and swine flu, say the team at University of Oxford.

It will offer people better protection, they believe.

Extra protection

Immunisation is the best defence we have against flu but it is not always effective.

Last winter’s vaccine cut the risk of flu in adults under the age of 65 by about 40%, but barely worked in people over 65, despite being a good match for the type of flu in circulation.

As people age, their immune systems are often weaker and their bodies may not respond as well to a vaccine as younger people’s bodies.

Prof Sarah Gilbert and colleagues believe that using their vaccine alongside the current one could help.

It is the world’s first widespread human testing of such a vaccine, according to the National Institute for Health Research, which is supporting the project.

 

Flu vaccine.jpg

Patients aged 65 or older and living in Berkshire and Oxfordshire will be invited to take part in the trial.

Half of the 500 volunteers will receive the usual seasonal flu jab and a placebo or dummy jab, while the other half with get the regular vaccine plus the new experimental one.

Read More: http://snip.ly/dqyht#http://www.bbc.com/news/health-41467097

Program for parents improves ADHD behaviors in young children

Program for parents improves ADHD beha

A program that focuses on strengthening parenting skills also improves symptoms of Attention Deficit/Hyperactivity Disorder (ADHD) in 3-8 year-olds, according to researchers at the at the University of North Carolina at Chapel Hill. FPG scientists completed a rigorous review of evidence that demonstrated the effectiveness of the “Incredible Years Basic Parent Program.”

“Prior research already has shown that this program improves behavior difficulties in young ,” said Desiree W. Murray, FPG’s associate director of research. “This review provides new evidence specifically about its effectiveness for ADHD symptoms.”

Murray explained that not only reported sustained improvements for their children’s ADHD behaviors, but also for their social skills and interactions with peers.

She said effective early intervention is crucial for young children with ADHD, due to the unfavorable short-term and long-term outcomes associated with the disorder.

“ADHD in preschoolers can bring conflict with family members, and it carries elevated risk of physical injuries and suspension or expulsion from child care settings,” Murray said. “Negative trajectories over time can include the development of other psychiatric disorders and difficulties with social adjustment.”

Previous studies have also shown that children with ADHD struggle academically, with lower test scores and higher risk of dropping out of high school.

“We can help to prevent the wide array of negative outcomes that are associated with ADHD,” Murray said. “We believe the most effective intervention approaches may be those that target preschoolers with symptoms of ADHD but who have not yet met the full criteria for diagnosis with ADHD.”

Murray and her team, which included FPG research scientist Doré R. LaForett and UNC doctoral student Jacqueline R. Lawrence, screened 258 studies and narrowed their list to 11 studies that met stringent criteria for rigor and methodology. The evidence—primarily parent reports—showed the effectiveness of the Incredible Years Basic Parent Program for ADHD behaviors in young children. The Journal of Emotional and Behavioral Disorders recently published the results of the team’s review.

The Incredible Years Basic Parent Program is designed for parents of high-risk children and those who display behavioral problems. It focuses on helping parents strengthen relationships with their children, providing praise and incentives, setting limits, establishing ground rules, and effectively addressing misbehavior.

Read More: http://snip.ly/kj65u#https://medicalxpress.com/news/2017-10-parents-adhd-behaviors-young-children.html

 

Man (35) in vegetative state for 15 years ‘showing signs of consciousness’

Man (35) in vegetative

A 35-year-old man who had been in a vegetative state for 15 years is showing signs of consciousness after receiving a pioneering treatment based on nerve stimulation.

In the month since a vagus nerve stimulator was put into his chest, the man, who was injured in a car accident, has begun responding to simple orders that had been impossible before.

The findings reported in Current Biology may help to show that by stimulating the vagus nerve “it is possible to improve a patient’s presence in the world”, according to lead researcher Angela Sirigu of Institut des Sciences Cognitives Marc Jeannerod in Lyon, France.

The researchers say it may challenge the view that a vegetative state which lasts for more than 12 months is irreversible.

“Other scientists have hailed it as “a potentially very exciting finding” but have also urged caution.

After treatment, it was reported the patient could follow an object with his eyes, turn his head on request and his mother said there was an improved ability to stay awake when listening to his therapist reading a book.

The vagus nerve connects the brain to many other parts of the body, including the gut.

It is known to be important in waking, alertness, and many other essential functions.

The patient, who was picked because he had been lying in a vegetative state for more than a decade with no sign of improvement, also appeared to react to a “threat”.

Researchers spotted that he reacted with surprise by opening his eyes wide when the examiner’s head suddenly approached his face.

 

Read More: http://snip.ly/sfxny#http://www.independent.ie/life/health-wellbeing/health-features/man-35-in-vegetative-state-for-15-years-showing-signs-of-consciousness-36173341.html

FDA approves first commercial product for peanut allergy prevention

FDA approves.jpg

The approach towards preventing peanut allergies has changed dramatically in recent years. Now the US Food and Drug Administration has approved the first commercial product, called Hello, Peanut!, to help inform the public that early peanut introduction and regular consumption can reduce the risk of peanut allergy in young children.

The Hello, Peanut! introduction kit offers convenience in the form of packets of peanut powder blended with oat given in increasing quantities for seven days, as long as children tolerate it well. After which maintenance packets are recommended for use up to three times a week. The introduction kit is $25, and the maintenance kit sells for $20 for eight packets.

The FDA decision was informed by the landmark Learning Early About Peanut Allergy study published in 2015. It showed that high-risk children who regularly consumed peanut in infancy had far fewer peanut allergies by age 5 than their counterparts who avoided peanut over the same span of time. This understanding led to new guidelines published in 2017 by National Institutes of Health about giving peanut to babies to protect against peanut allergy.

Infants who have severe eczema or egg allergy are considered at high-risk of developing a peanut allergy. By offering peanut early in life – between 4-6 months of age – and continuing with regular consumption, we can prevent the onset of peanut allergy in many of these children. High-risk children should see their doctor before parents introduce peanut protein in any form. The physician may decide to do skin or blood testing.  If the test is negative, age-appropriate peanut products can be given at home. However, if a child tests positive, introduction to peanut is done under clinical supervision. If the child is deemed already allergic to peanuts, the guidelines recommend strict avoidance of peanut and ready access to epinephrine auto-injectors.

Read More: http://snip.ly/ktety#http://www.philly.com/philly/health/kids-families/fda-approves-first-commercial-product-for-peanut-allergy-prevention-20170926.html

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/