Modernizing the Food Safety System.

The U.S. Food and Drug Administration (FDA) today took one of the most significant steps in decades to prevent foodborne illness by finalizing the first two of seven major rules under the bipartisan FDA Food Safety Modernization Act (FSMA).

Today’s action is the first step in putting greater emphasis on the prevention of foodborne illness, holding imported food to the same food safety standard as domestically produced food, and developing a nationally integrated food safety system in partnership with state and local authorities.

An estimated 48 million people (1 in 6 Americans) get sick each year from foodborne diseases, according to recent data from the U.S. Centers for Disease Control and Prevention. Approximately 128,000 are hospitalized, and 3,000 die each year. Over the past few years, high-profile outbreaks related to various foods, from spinach to peanut products, have underscored the need to make continuous improvements in food safety.

“Today’s announcement sets us on the path to a modern food safety system that will prevent illnesses and continue to build confidence in the safety of the food served to our families every day,” said Dr. Stephen Ostroff, acting FDA commissioner.

The two rules finalized today, the preventive controls rules, focus on implementing modern food manufacturing processes for both human and animal foods.  Today’s announcement will ensure that food companies are taking action and working with the FDA to prevent hazards to customers on the front end, rather than waiting to act until an outbreak has occurred.

The preventive controls rules require human and animal food facilities to develop and implement written food safety plans that indicate the possible problems that could affect the safety of their products and outline steps the facility would take to prevent or significantly minimize the likelihood of those problems occurring. This means that food companies will be accountable for monitoring their facilities and identifying any potential hazards in their products and prevent those hazards.  Under these rules, the FDA will be able to assess these systems and their outcomes to prevent problems, will better be able to respond when food safety problems occur, and better protect the safety of manufactured food.

The preventive controls final rules announced today are the result of an extensive outreach effort, and incorporate thousands of public comments, including valuable input from farmers, consumers, the food industry and academic experts, to create a flexible and targeted approach to ensuring food safety.

“We’ve been working with states, food companies, farmers and consumers to create smart, practical and meaningful rules,” said Michael R. Taylor, deputy commissioner for foods and veterinary medicine, FDA. “And we have made a firm commitment to provide guidance, technical assistance and training to advance a food safety culture that puts prevention first.”

Once the seven FSMA rules are finalized in 2016, they will work together to systematically strengthen the food safety system and better protect public health.

The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety and effectiveness of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety of our nation’s food supply, cosmetics, dietary supplements, and products that give off electronic radiation, and for regulating tobacco products.

New grants to boost the development of products for patients with rare diseases

The U.S. Food and Drug Administration today announced it has awarded 18 new research grants totaling more than $19 million to boost the development of products for patients with rare diseases, which affect the lives of nearly 30 million Americans. These new grants were awarded to principal investigators in ten states, with research spanning clinical sites domestically and internationally.

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New Drug for treatment of Diabetes

he U.S. Food and Drug Administration today approved Tresiba (insulin degludec injection) and Ryzodeg 70/30 (insulin degludec/insulin aspart injection) to improve blood sugar (glucose) control in adults with diabetes mellitus.

 

“Long-acting insulins play an essential role in the treatment of patients with type-1 diabetes and in patients with type-2 diabetes with advanced disease,” said Jean-Marc Guettier, M.D., director of the Division of Metabolism and Endocrinology Products in the FDA’s Center for Drug Evaluation and Research. “The FDA remains committed to support the development of innovative therapies for the treatment of diabetes.”

Tresiba is a long-acting insulin analog indicated to improve glycemic control in adults with type 1 and 2 diabetes mellitus. Dosing of Tresiba should be individualized based on the patient’s needs. Tresiba is administered subcutaneously once daily at any time of day.

The efficacy and safety of Tresiba used in combination with mealtime insulin for the treatment of patients with type-1 diabetes were evaluated in two 26-week and one 52-week active-controlled clinical trials involving 1,102 participants exposed to Tresiba. The efficacy and safety of Tresiba used in combination with mealtime insulin or used as add-on to common background oral antidiabetic drugs for the treatment of patients with type-2 diabetes were evaluated in four 26-week and two 52-week active-controlled clinical trials involving 2,702 participants exposed to Tresiba. In participants with type 1 and 2 diabetes who had inadequate blood sugar control at trial entry, treatment with Tresiba provided reductions in HbA1c (hemoglobin A1c or glycosylated hemoglobin, a measure of blood sugar control) in line with reductions achieved with other, previously approved long-acting insulin.

Ryzodeg 70/30 is a mixture of insulin degludec, a long-acting insulin analog, and insulin aspart, a rapid-acting human insulin analog. It is indicated to improve glycemic control in adults with diabetes mellitus. 

The efficacy and safety of Ryzodeg 70/30 used in combination with mealtime insulin for the treatment of patients with type 1 diabetes were evaluated in one 26-week active controlled clinical trial involving 362 participants exposed to Ryzodeg 70/30. The efficacy and safety of Ryzodeg 70/30 administered once or twice daily for the treatment of patients with type 2 diabetes were evaluated in four active controlled 26-week clinical trials involving 998 participants exposed to Ryzodeg 70/30. In participants with type 1 and 2 diabetes who had inadequate blood sugar control at trial entry, treatment with Ryzodeg 70/30 provided reductions in HbA1c equivalent to reductions achieved with other, previously approved long-acting or pre-mixed insulin.

Tresiba and Ryzodeg should not be used in those who have increased ketones in their blood or urine (diabetic ketoacidosis). Patients or caregivers should monitor blood glucose in all patients treated with insulin. Insulin regimens should be modified cautiously and only under medical supervision. Tresiba and Ryzodeg may cause low blood sugar (hypoglycemia), which can be life-threatening. Patients should be monitored more closely with changes to insulin dosage, co-administration of other glucose-lowering medications, meal pattern, physical activity, and in patients with renal impairment or hepatic impairment orhypoglycemia unawareness.

Severe, life-threatening, generalized allergy, including anaphylaxis, generalized skin reactions, angioedema, bronchospasm, hypotension, and shock may occur with any insulin.

The most common adverse reactions associated with Tresiba and Ryzodeg in clinical trials were hypoglycemia, allergic reactions, injection site reactions, pitting at the injection site (lipodystrophy), itching, rash, edema, and weight gain.

Tresiba and Ryzodeg are manufactured by Novo Nordisk in Plainsboro, New Jersey.

The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.

Mood Disorders after Parasite Deployment

In a study a few years ago, rats infected with a certain parasite not only overcame their aversion to cat urine, but became attracted to it.

In other words, they lost their natural fear of cats. The parasite is Toxoplasma gondii. About a third of the people on earth are thought to be chronically infected with it, usually without symptoms.

But in the past decade or so, scientists have begun to realize that some people – like rats – can develop serious behavioral problems when the parasite infects their brain. Schizophrenia, depression, suicidality, bipolar disorder, obsessive–compulsive disorder, neuroticism, hyperactivity – all have been linked to the bug in studies around the world.

Now, a team of VA and university researchers has raised the question of whether T. gondii might be partly to blame for the mood disorders that some troops experience after deployment. In the June 2015 issue of Military Medicine, the researchers reported the results of a small pilot study involving 70 women Veterans of various ages.

Eight of the women tested positive for T. gondii, which can be detected in the blood. Six of these eight had been deployed abroad during their military career.

All the women completed questionnaires measuring PTSD and mood symptoms. Those women who were infected scored significantly higher – worse, that is – for depression, anger, confusion, and overall mood disturbance.

Can Technology replace Doctors?

It’s true.

Health care technology is transforming at record speeds, almost at pace with Apple’s release of a new iPhone. A digitally globalized world means more power than ever is in the hands of the patient.

Around one in 10 Americans wear some form of technology on a daily basis, whether it’s a smart–phone or a device to track medical information. It may sound like the premise of a science fiction film, but Mark Benden, C.P.E., Ph.D., associate professor at the Texas A&M Health Science Center School of Public Health, director of the Texas A&M Ergonomics Center and member of the Center for Remote Healthcare Technologies and Systems, believes wearable technology is rapidly approaching the point where devices become omniscient about a patient’s needs and personal habits. “We see wearable devices on a daily basis.

The most common devices – like the Fitbit – are built–in mechanisms that communicate with your cell phone. Soon, we will have devices in all environments – they will monitor us in our homes, while we’re at work and during our personal lives.

As these different devices ‘talk’ to each other, they will be able to know people’s habits and practices. Essentially, they will coach and motivate patients,” Benden said.

And in health care, this type of scientific advancement is powerful. With more than 140 million Americans living with at least one chronic medical condition, these devices could keep patients out of the hospital and monitored on a routine basis.

Epirus enters into collaboration with Polpharma

polpharma

 Epirus Biophrmaceuticals Limited and Polpharma Group today announced the signing of a multi-product, multi-region profit-sharing collaboration for select EPIRUS biosimilars, including BOW015 (infliximab, reference biologic Remicade®), BOW050(adalimumab, reference biologic Humira®) andBOW070 (tocilizumab, reference biologic Actemra®), representing $6 billion in innovator sales in the specified territoriesi.

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Federal judge enters permanent injunction against Wisconsin dietary supplement manufacturers

Three dietary supplement companies, under the same ownership and located in Wautoma, Wisconsin, will not be allowed to manufacture or sell dietary supplement products until FDA has determined that the businesses are in compliance with federal manufacturing regulations and other requirements, according to a federal court order signed Aug. 4, 2015.

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