FDA

FDA announces to expand access to abortion pill restricted since 2000

FDA announces to expand access to abortion pill restricted since 2000

In the states which had limited access of an abortion-inducing pill, the Food and Drug Administration (FDA) has expanded access to it through its guidelines issued on Wednesday. Women in states like North Dakota, Ohio and Texas are exempt from the 16 years old FDA regulations which doctors have been following.

The new rule announced on Wednesday claimed that women seeking the pill could use that for 70 days after the start of their most recent menstrual period, up from 49 days under the previous guidelines. FDA also made the prescription for pills easier to get and also reduced the dosage of the medication, called mifepristone, from 600 milligrams to 200 milligrams. The new guidelines are update to the old rule being followed since 2000.

FDA Issues Guidance Outlines for Generic Opioids

FDA Issues Guidance Outline for Generic Opioids

The Food and Drug Administration (FDA) has formulated an outline for a guidance to offer support to pharmaceutical industry in its efforts to develop generic variants of opioid drugs that have been approved by it.

The generic variants will be developed using abuse-deterrent formulations (ADF). However, the FDA has revealed that generic ADF opioids will also be equally abuse-deterrent as the brand-name drug. This guidance is one of the several measures being taken by the FDA under an action plan for the re-evaluation of its advancement towards opioid drugs.

FDA gives Green Light to Cinqair for Treating Severe Asthma

FDA gives Green Light to Cinqair for Treating Severe Asthma

A maintenance drug, Cinqair, can be used with other asthma medicines to treat adults with severe asthma, announced the Food and Drug Administration (FDA). The new drug will be used for the maintenance treatment of people with a history of severe asthma attacks, the federal agency said.

Asthma is a chronic medical condition that makes breathing difficult by narrowing the air passage. It causes symptoms such as wheezing, coughing and chest tightness. A sufferer of severe asthma attacks may visit hospital’s emergency room because the condition is serious and deadly.

FDA approves Cinqair for severe asthma

FDA approves Cinqair for severe asthma

The U.S. Food & Drug Administration (FDA) on Wednesday approved Teva Pharmaceuticals’ Cinqair (reslizumab) for the treatment of severe asthma, after a study showed promising results.

Approving the drug, FDA said adult patients might take Cinqair together with other medicines for the treatment and maintenance of severe asthma. Asthmatic patients who have a history of severe attacks are expected to get significant respite from the supportive drug.

FDA’s Center for Drug Evaluation & Research Director Badrul Chowdhury said, “Health care providers and their patients with severe asthma now have another treatment option to consider when the disease is not well controlled by their current asthma therapies.”

FDA planning to add new boxed warning to all immediate-release opioid painkillers

FDA planning to add new boxed warning to all immediate-release opioid painkiller

As part of a multipronged government campaign aimed at reversing an epidemic of abuse and death linked to drugs such as Vicodin and Percocet, federal health regulators are planning to bolster caution labels on the most commonly used prescription painkillers.

On Tuesday, the Food and Drug Administration (FDA) shared plans of addition of a new boxed warning, most severe kind of warning, to all immediate-release opioid painkillers, like combination pills that contain oxycodone and nonprescription drug ingredients.

In the US, the drugs, sold as Vicodin and a number of generic brands, have been among the most prescribed drugs. They accounted for over 135 million prescriptions in the US in 2012.

FDA proposes Ban on Powdered Surgical Gloves, citing Health Risks

FDA proposes Ban on Powdered Surgical Gloves, citing Health Risks

Health professionals may no longer be allowed to wear powdered surgical gloves as Food and Drug Administration (FDA) has decided to ban most of the surgical gloves that are made with powder on the surface.

There are some latex gloves that can harm both a patient and a doctor, announced the U.S. FDA on Monday. Powdered surgical gloves are easier to wear, but they could cause a number of problems including breathing issues and wound inflammation, as per the agency.

A government-funded study found that the ban will not affect manufacturer sales and glove supplies in the country. Most of the powdered gloves have been banned, and just six manufacturers are still supplying these gloves in the country, said FDA.

FDA to review Abbott's one-of-a-kind dissolving medical implant to weigh its potential risks

FDA to review Abbott's one-of-a-kind dissolving medical implant to weigh

On Tuesday, the United States Food and Drug Administration (FDA) is going to review Abbott's one-of-a-kind dissolving medical implant to evaluate its possible risks for the patients of heart attack and blood clot.

Abbott has requested FDA to approve its novel coronary stent, known as Absorb, as a substitute to metal stents, which has been in use for the treatment of narrowing arteries that generally result into heart attack or death.

Abbott's Absorb isn’t like traditional bare-metal stents that stay in place. Instead, it disappears within the body in a time span of three years after clearing fat-clogged arteries.

FDA approves Xalkori (crizotinib) as treatment for patients with ROS1-positive metastatic NSCLC

FDA approves Xalkori (crizotinib) as treatment for patients with ROS1-positive

Xalkori (crizotinib) has been passed by the FDA as a treatment for patients suffering from ROS1-positive metastatic non-small cell lung cancer (NSCLC). The decision has been taken on the basis of the demonstration of substantial effectiveness in a phase 1 study.

It was based on data from 50 patients with ROS1-positive NSCLC wherein 66% was the overall response rate (ORR) with a median time period of response of 18.3 months by independent review.

Firstly a breakthrough therapy designation was given and then the approval arrived nearly 30 days ahead of a deadline decided under the Prescription Drug User Fee Act.

Sleeping Disorders should be taken seriously

Sleeping Disorders should be taken seriously

Many people suffer from the problem of snoring and eventually getting up with an irritable mood in the morning. These are the common symptoms of a condition called obstructive sleep apnea (OSA), which is a type of sleeping disorder and must not be left unattended. If a person ignores these problems, it might result in high blood pressure and stroke, along with heart attacks and road accidents.

Sleep problems can also lead to depression and poor performance at work. Over 12 million people in the United States suffer from OSA, according to the American Sleep Association.

FDA and Amarin reach deal allowing the company endorse drug for off-Label use

FDA and Amarin reach deal allowing the company endorse drug for off-Label use

The Food and Drug Administration (FDA) has allowed Amarin Corporation to endorse a drug for off-label use, said the company in a statement on Tuesday. The drug by the New Jersey headquartered drug-maker will be promoted for a use that the federal agency has not allowed yet.

The new deal will resolve a conflict between FDA and the company that last year went to court against the federal agency for its product, Vascepa. Amarin claimed that it has the right to promote a drug that can help many people. In August, a Manhattan judge ordered the FDA not to stop the drug-maker from promoting truthful information on the drug.

Now, the FDA and the biopharmaceutical company have agreed on a deal and eying on the court to approve it.

Breakfast sandwich sold at Starbucks recalled over listeria fears

Breakfast sandwich sold at Starbucks recalled over listeria fears

Starbucks’ pre-packaged sausage, egg, and cheddar cheese on English muffin breakfast sandwiches from its Arkansas, Texas, and Oklahoma stores have been recalled over concerns that the products could have traces of listeria.

The contaminated products belong to Progressive Gourmet, a Wilmington, Massachusetts supplier. It is packed in a six-ounce, clear plastic, and has been marked with ‘Best Before: 07-AUG-2016’.

In an online statement, the FDA noted that the Seattle-based coffee chain has pulled off the sandwiches from its all 250 stores that have probably received it.

Federal Health Officials want to Improve Digital Health Records

Federal Health Officials want to Improve Digital Health Records

To make digital health records easily accessible to consumers and regulators, a deal has been announced by federal health officials. It emphasizes on ensuring safety of data. Other infinitives are to stop practice of information blocking, adopting universal language and improving the system that enables patients to keep record of their health status.

FDA requires new ‘black box warning’ label for Essure

FDA requires new ‘black box warning’ label for Essure

A new ‘black box warning’ label has been made mandatory for Essure by the US Food and Drug Administration. Essure is an implantable permanent contraceptive device.

According to the FDA website, a black box warning in products’ labeling has been planned to call attention to severe and life-threatening risks.

The FDA has made an announcement on Monday after it received grievances from over 5,000 women between November 2002 and May 2015. The women complained of unplanned pregnancies, miscarriages, stillbirths and severe pain and bleeding post an Essure implantation.

Senate announces Dr. Robert Califf as New FDA Commissioner

Senate announces Dr. Robert Califf as New FDA Commissioner

The Senate confirmed Wednesday that Dr. Robert M. Califf will be the new commissioner of the U.S. Food and Drug Administration (FDA). In a vote of 89 to 4, cardiologist Califf has won the race to be the next FDA Commissioner.

The decision in favor of President Barack Obama’s pick has come after a few months of opposition from some lawmakers who tried their best to block Califf’s nomination. In their speeches, they even urged other lawmakers to vote against Dr. Califf, a clinical researcher from Duke University.

Graphic images on cigarette packs won’t stop smokers from lighting up

Graphic images on cigarette packs won’t stop smokers from lighting up

Smokers and non-smokers agree that they don’t like graphic images on cigarette packs, but they also think that the pictures still won’t keep them away from lighting up a cigarette.

University of Illinois researchers have discovered that the pictures made people feel as if their freedoms have been infringed on, and in some cases boosted people's smoking habit.

Big warnings, pictures of diseased body parts, and images of people losing lives from smoking-related diseases have reduced smoking rates in nations where they've been placed on cigarette wrappers.

A number of regulations in other nations were coupled with fresh taxes or restrictions, which, as per the researchers, could also have resulted in a fall in cigarette smoking.

Lawmakers clear way for confirmation of Robert Califf as new FDA commissioner

Lawmakers clear way for confirmation of Robert Califf as new FDA commissioner

On Monday, lawmakers cleared the way for confirming Robert Califf as the new commissioner of the Food and Drug Administration, despite objections from senators, who were criticizing his links with the pharmaceutical industry. Califf is a longtime cardiologist and Duke University researcher.

The Senate has overpoweringly supported a procedural motion to stop any legislator from hindering a vote on Califf’s nomination and to restrict debate over the decision to 30 hours. A final vote is expected to come by Tuesday. Many senators have held up the confirmation of Califf in the recent months.

FDA could have greatly underestimated fetal deaths from Bayer AG's Essure contraceptive device

FDA could have greatly underestimated fetal deaths from Bayer AG's Essure contra

As per a private analyst who combed through the public database of the US Food and Drug Administration, the agency has probably greatly underestimated the number of fetal deaths in women who got pregnant after using Bayer AG's Essure contraceptive device.

The FDA has mentioned five fetal deaths in women who conceived with the help of Essure, two metal coils put into the fallopian tubes.

A spokeswoman for Bayer said, “Irrespective of the type of birth control a woman uses, when pregnancies do occur, there can be complications. It would be irresponsible to suggest that Essure causes fetal deaths when, after an unsuccessful Essure procedure, an undesired pregnancy cannot be carried to term”.

Eating Fish during Pregnancy Increases Child Obesity Risk

Eating Fish during Pregnancy Increases Child Obesity Risk

A new research, conducted at the University of Crete in Greece has revealed that babies are at a higher risk of becoming obese if their mothers had consumed fish three or more times in a week. A meta-analysis of 15 studies was carried out by the researchers, involving a total of 26,184 pregnant women and their children from 11 countries across the United States and Europe. The data on the babies born from 1996 to 2011 was tracked by the researchers.

CTI BioPharma's IND for pacritinib placed on full clinical hold

CTI BioPharma's IND for pacritinib placed on full clinical hold

CTI BioPharma Corp said that the US Food and Drug Administration (FDA) has placed a full clinical hold on its investigational latest drug application for pacritinib. The company said that it has taken back its application for the experimental blood cancer drug and is going to review the safety and efficacy data.

The regulator also suggested that CTI should request for a meeting before it submits its response to the full clinical hold.

Earlier on February 4, the FDA had put a partial hold on pacritinib, citing excess mortality and other bad events in pacritinib-treated patients.

As part of the full clinical hold, all patients on pacritinib should discontinue it right away and no patients can get enrolled or begin pacritinib as early or crossover treatment.

Walgreens Mulls snapping Partnership with Theranos

Walgreens Mulls snapping Partnership with Theranos

Walgreens and Theranos had entered into a partnership just over two years ago to make the latter’s revolutionary blood test technology available to people through the pharmacies of Walgreens across the nation. However, the partnership seems to be suffering a setback due to the regulatory issues with the Theranos’ operations. For the time being, Walgreens has closed its only Theranos Wellness Center in California and is mulling over the decision to be taken regarding the rest 40 centers in Arizona.




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