FDA

FDA Formally proposes to allow Gay and Bisexual Men to Donate Blood

FDA Formally proposes to allow Gay and Bisexual Men to Donate Blood

On Tuesday, the Federal Drug Administration has proposed its newly drafted policy as per which, gay men will be able to donate blood. It will happen for the first time in 30 years that gay men would also be eligible for donating blood.

The draft proposal stated, “Male donors previously deferred because of a history of sex with another man, even one time, since 1977, may be eligible to donate provided that they have not had sex with another man during the past 12 months and they meet all other donor eligibility criteria”.

In 1985, the FDA came up with new regulations as per which, the men who had sex with even one man after 1977 were not allowed to donate blood. The FDA took this step at the time when HIV/ AIDS epidemic was on. Also, the FDA wanted to prevent further cases of HIV.

FDA Report brings out Most Detailed Look to Date into Blue Bell’s Operation

FDA Report brings out Most Detailed Look to Date into Blue Bell’s Operation

On Thursday, an extensive report has been issued by the US Food and Drug Administration. As per it, Blue Bell knew Listeria findings at its Oklahoma plant by 2013. It was two years before another outbreak took place in which the company made the first recall in 108 years.

At Brenham plant, the company knew about the Listeria contamination since February 2013. But the company did not make a recall before March 13. It also took place even a health worker in South Carolina found Listeria strains in Blue Bell products, which matched with Listeria strains from five hospital patients in Kansas.

FDA grants advanced therapy designation for venetoclax

FDA grants advanced therapy designation for venetoclax

According to Swiss drugmaker Roche, the US Food and Drug Administration (FDA) has granted advanced therapy designation for venetoclax for treating people who have relapsed or refractory chronic lymphocytic leukemia with a genetic abnormality.

Roche Chief Medical Officer and Head of Global Clinical Development Sandra Horning said in a statement that they are excited that FDA has granted venetoclax breakthrough therapy designation and they look forward to this regulatory pathway, which according to them will help them bring venetoclax to people with this disease.

Healthcare Antiseptics: A Boon or a Bane

Healthcare Antiseptics: A Boon or a Bane

Following the draft regulation published by the U. S. Food and Drug Administration (FDA) in December 2013 requiring a thorough review of the safety of antibacterial soaps and sanitizers used by consumers, this Thursday, the FDA proposed a rule to check the effectiveness of the same products for healthcare personnel.

FDA seeks more data about Antiseptic Sanitizers used in Health Care Settings

FDA seeks more data about Antiseptic Sanitizers used in Health Care Settings

The Food and Drug Administration (FDA) has called for more data about antiseptic sanitizers used in health care settings, including hospitals. The request is applicable on products, including antibacterial soaps and hand washes.

The federal agency wants to find out if the products are as safe and effective as they were the last time, when the organization thoroughly investigated the subject, 40 years ago.

Antiseptic manufacturers have been asked to supply the FDA with information on how their products may be affective in the rise of antibiotic-resistant microorganisms, and absorption into the bodies of users, and about its possible hormonal effects.

Glaxo, Theravance's Breo Ellipta Asthma Drug gets Approval from US FDA

Glaxo, Theravance's Breo Ellipta Asthma Drug gets Approval from US FDA

The sale of Breo Ellipta has got approval from the US Food and Drug Administration as a once-daily treatment for asthma in patients aged 18 and older, said GlaxoSmithKline and Theravance Inc.

The FDA said the treatment could not be approved for use in younger asthma sufferers as it's not safe for them. The agency said that only additional data could confirm Breo's safety and efficacy in that population.

The FDA gave its nod to the treatment after an FDA advisory panel of experts had voted 16-4 for use in adults. However, it voted 19-1 that data was not substantial enough to prove that it's safe for use in children aged 12 to 17.

FDA issues warning to companies to stop selling dietary supplements that include DMBA

FDA issues warning to companies to stop selling dietary supplements that include

Many companies have received a warning from the US Food and Drug Administration to stop selling dietary supplements that contain a stimulant known as DMBA.

As per experts, it is the latest in a series of moves to clamp down on potentially dangerous weight-loss and body-building products. Earlier this month, the agency had issued warning to five companies to stop selling dietary supplements that include a stimulant known as beta-methylphenylethylamine (BMPEA). According to the experts, BMPEA is frequently hidden in supplements that contain Acacia rigidula.

Lawmakers and a Harvard University academic, Dr. Pieter Cohen, has asked the FDA to take some steps. Dr. Pieter Cohen has been examining the presence of synthetic stimulants in supplements.

FDA to speed up review of Fabry Therapy, says Genzyme

FDA to speed up review of Fabry Therapy, says Genzyme

Genzyme, a Sanofi company, said on Tuesday that the United States Food and Drug Administration (FDA) has agreed to speed up review for the development of GZ/SAR402671. Sanofi’s GZ/SAR402671 is a new investigational oral substrate reduction therapy, which can treat Fabry disease.

Fabry disease is an inherited, potentially fatal disorder, which is characterized by the buildup of a particular type of fat. That fat can results in cell damage, which could lead to pain, kidney failure, hearing loss, stroke and heart attack.

Chipotle becomes first GMO-free national fast food chain

Chipotle becomes first GMO-free national fast food chain

Chipotle Mexican Grill Inc. said that its food is now free from genetically modified organisms (GMO). For more than two years, the major restaurant chain, which has 1,831 restaurants, has been working to eliminate ingredients made with GMOs.

These include corn, soybeans and other crops whose DNA is altered to make them pest-resistant. The company had said it had earlier expected that this would happen by the end of 2014. However, the transition took a little longer.

Chipotle has become the first restaurant to remove GMO from its foods amid growing US consumer questions about the agricultural technology.

The Food and Drug Administration (FDA) has approved a number of genetically modified crops, which are considered to be safe by many science groups.

FDA approves Sandoz’s Glatopa to Treat Multiple Sclerosis

FDA approves Sandoz’s Glatopa to Treat Multiple Sclerosis

Sandoz, a Novartis company, announced that the United States Food and Drug Administration (FDA) has approved its Glatopa, which the first generic alternative version for Teva Pharmaceutical's multiple sclerosis treatment Copaxone. According to reports, Glatopa has been approved as treatment for multiple sclerosis.

After the approval, now the subsidiary of Novartis could market the drug. According to reports, Sandoz developed the new drug in partnership with Momenta Pharmaceuticals, a pharmaceutical company based in Massachusetts. The drug will be helpful in treating patients with relapsing forms of multiple sclerosis (MS). Some patients with severe MS lose the ability to walk independently or at all.

New Powdered Alcohol Product Draws Attention of Federal and State Legislators

New Powdered Alcohol Product Draws Attention of Federal and State Legislators

Last week, FDA has been asked by New York Senator Charles Schumer to ban a new powdered alcohol product named Palcohol.

In 2012, Mark Philips developed the product motivated by "a love of hiking but a distaste for carrying bottles of adult beverages uphill." Already, the product has attracted attention of federal and state legislators. It has been notified that the product ready for release in stores this summer.

Up to now, six states have enacted legislation banning any form of powdered alcohol. A bill that might ban the sale and manufacture of Palcohol nationwide has been introduced by Schumer last month. But these sanctions are unfair. Particularly, worries are there about potential snorting of the product.

MDCO receives votes in favor of its blood clot preventer by FDA’s CRDAC

MDCO receives votes in favor of its blood clot preventer by FDA’s CRDAC

On Wednesday, MDCO announced that an independent advisory panel to the US Food and Drug Administration (FDA) has voted to recommend approval of company's intravenous blood clot preventer in angioplasty procedures.

The Cardiovascular and Renal Drugs Advisory Committee (CRDAC) voted 9-2 to support the approval of investigational intravenous anti-platelet agent cangrelor for patients undergoing percutaneous coronary intervention (PCI), which is commonly known as angioplasty.

The PCI is performed to widen narrowed or clogged coronary arteries that often include the use of stents. The panel voted for cangrelor to reduce the risk of periprocedural thrombotic events such as myocardial infarction (MI), stent thrombosis (ST) and ischemia-driven revascularization.

FDA gives nod to Amgen’s Heart-Failure Treatment Corlanor

FDA gives nod to Amgen’s Heart-Failure Treatment Corlanor

Amgen's heart-failure treatment Corlanor has got a green signal from the US Food and Drug Administration. The drug was designated for priority review in August.

The drug is believed to have high efficacy of regulating heart rate and reducing the risk of hospitalization for worsening heart failure. The drug is meant for patients with stable, chronic heart failure caused by a poorly-contracting lower-left part of the heart.

The drug is an oral medication and the FDA has approved it as the first new chronic heart-failure medicine in nearly a decade. Each year, an estimated $31 billion comes as cost of heart failure in the US, as per the company. Majority of the cost is associated with hospitalizations.

FDA objects to use of ‘healthy’ word and ‘+’ symbol on KINDSnacks’ products and website

FDA objects to use of ‘healthy’ word and ‘+’ symbol on KINDSnacks’ products

The Food and Drug Administration has asked KINDSnacks, which manufactures fruit, nut and grain bars, to remove the word 'healthy' from its packaging and website, in addition to the '+' symbol. The FDA watches out that which packaged foods use the word 'healthy' and the symbol '+' for their marketing purposes. The use of such words is not taken very seriously, however in terms of food regulation, it indicates a totally different meaning.

On Tuesday, a letter detailing the FDA's objections was posted on the agency's website. 'Healthy' word indicates that the product has one gram or less of saturated fat. And the calories from saturated fat should not exceed 15% of the total.

FDA should ban Dietary Supplements that contain BMPEA: Charles Schumer

FDA should ban Dietary Supplements that contain BMPEA: Charles Schumer

Earlier, officials found that a number of supplements that promise weight-loss or boost energy for exercising contained a harmful chemical that resembles amphetamine. According to reports, the United States Food and Drug Administration (FDA) did not ban such supplements.

Health experts advised that there are a number of products that could be contaminated with the chemical. Before taking supplements to lose weight or boost energy for exercising, an individual should double check what is in the product.

Swedish Match must not be allowed to Alter Warning Label on its Snus Smokeless Tobacco Products: FDA

Swedish Match must not be allowed to Alter Warning Label on its Snus Smokeless T

An advisory panel to the US Food and Drug Administration said that Swedish Match must not be permitted to change the warning label on its snus smokeless tobacco products to claim they are less harmful compared to cigarettes.

The Stockholm-based company is looking for the FDA approval in order to remove warnings about mouth cancer, gum disease and tooth loss from its snus products and also to state that they offer a ‘substantially’ lower risk as compared to cigarettes.

Sabra Dipping Company recalls about 30,000 cases of its Classic hummus Products

Sabra Dipping Company recalls about 30,000 cases of its Classic hummus Products

The United States-based Sabra Dipping Company has announced that it is going to recall approximately 30,000 cases of its classic hummus products. According to the company, it has found that a number of samples were contaminated with listeria.

According to reports, several samples of Sabra's classic hummus products were discovered contaminated with listeria at the company's Michigan plant. Listeria was discovered during a routine testing by the Michigan Department of Agriculture and Rural Development (MDARD), the reports further stated. After discovering listeria, the officials alerted inspectors in Virginia and the United States Food and Drug Administration (FDA). Currently, they have been working to resolve the problem.

FDA accepts Novo Nordisk’s resubmitted Application for Tresiba

FDA accepts Novo Nordisk’s resubmitted Application for Tresiba

Danish multinational pharmaceutical company Novo Nordisk announced that the US Food and Drug Administration (FDA) has accepted its application for the company's key insulin drug, Tresiba, based on interim analysis data from a clinical trial. According to reports, the application was resubmitted by the pharmaceutical company headquartered in Bagsvaerd, Denmark.

Novo Nordisk's Tresiba was refused by the federal agency of the United States Department of Health and Human Services about two years ago. According to the agency, there are chances that the drug could be associated to higher rate of heart attack or stroke. Novo Nordisk's drug is available outside the United States.

Breast Milk sold Online could be adulterated with Cow’s milk

Breast Milk sold Online could be adulterated with Cow’s milk

The U. S. FDA has warned women about breast milk being sold online. The FDA said that it could lead to certain serious health and adulteration risks. And now, researchers are also supporting the warnings.

A novel study published in the journal Pediatrics has found that 10% of breast milk samples bought online were mixed with cow's milk. The researchers bought 102 bottles of breast milk online and then they assessed the samples for human DNA or bovine DNA from cows.

FDA and L.A. Star Seafood enter into Consent Decree

FDA and L.A. Star Seafood enter into Consent Decree

The US Department of Justice (DOJ) has ordered L. A. Star Seafood Company to stop processing and distributing smoked, salt-cured and pickled seafood products until they improve their sanitary conditions and work as per the Federal Food, Drug and Cosmetic Act.

The Los Angeles food processor and distributor was given the orders as links were found between its ready-to-eat smoked and pickled fish and listeriosis and botulism. The prosecutors were of the view that the manufacturer has been targeted earlier as well by inspectors with the US Food and Drug Administration.

Last Thursday, US District Judge Michael W. Fitzgerald entered into a consent decree of permanent injunction (PDF) against the company and its owners, Sam and Sima Goldring.




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