Federal Food & Drug Administration

Federal Food & Drug Administration12 posts
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9 Oct, 2015

Opposes Califf nomination

Sanders says he will vote against Dr. Califf as the next commissioner of the FDA, citing the nominee’s close ties to the pharmaceutical industry.

Instead of listening to the demands of the pharmaceutical industry and their 1,400 lobbyist, it is about time that the FDA and Congress started listening to the overwhelming majority of the American people, who believe that medicine is too expensive.

22 Sep, 2015

FDA to re-examine


The FDA says it will hold a meeting on September 24 to re-examine the safety of Essure, a birth-control method that was approved in 2002. Essure is marketed as the only permanent birth control method that does not require surgery. While Bayer has acknowledged side effects including pelvic pain, migration of the device or rash, women have said they have experienced other unlisted side effects.


Over the past several years, the Agency met with patients and patient advocates to better understand patient issues and experiences after Essure placement. We will continue to work with these individuals as we continue our efforts to better understand their experiences with this device.

Bayer says it appreciates the opportunity to discuss the matter with the FDA.

While there are risks with all medical devices and procedures, our highest priority is patient safety, and we sympathize greatly with any woman who has experienced problems with Essure.

18 Sep, 2015

Fast tracked


ZMapp is granted fast track approval in America. LeafBio says the grant is an “important milestone” which brings them closer to eventually gaining approval. The drug has been administered under emergency use authorization to nine infected patients in Africa in addition to two infected missionaries in Europe during its first clinical trial. LeafBio CEO Whaley:

We are gratified to receive this designation for ZMapp. We are hopeful that this step will accelerate its access once safety and efficacy are demonstrated to satisfaction by FDA in ongoing clinical trials.

10 Jul, 2015

21st Century Cures bill approved

Introduces Bill

The House of Representatives pass the “21st Century Cures Act” which increases research funding through the National Institutes of Health (NIH) by $9 billion over the next five years. The bill also provides $550 million over the next 5 years to expedite the discovery and approval of drugs by the Federal Food and Drug Administration (FDA). The bill also adds provisions to give drug companies more time to market drugs and increase the efficiency of collecting patient input. Some researchers and consumer advocates say the bill includes provisions that cuts corners in the drug approval process that undermine patient safety. Critics:

Some aspects of the bill could indeed enhance the development of and access to new drugs. Embedded in the language of the 21st Century Cures Act are some good ideas that could streamline the development and evaluation of new drugs and devices; its call for increased NIH funding may prove to be its most useful component. But political forces have also introduced other provisions that could lead to the approval of drugs and devices that are less safe or effective than existing criteria would permit

9 Jul, 2015

Painkiller warnings strengthened

Makes Statement

FDA strengthens warning levels for painkillers that increase the risk of strokes and heart attacks, further warning individuals with a history of heart attacks, hypertension, or other heart disease to be cautious about using non-steroidal inflammatory drugs (NSAID). This is in response to recent data that show the increase in the risk of strokes and heart attacks following short-term NSAID use. FDA requires drug makers to update warnings on common products that contain NSAIDs such as Motrin, Advil, Aleve and other products used for the management of pain, fever, and inflammation. The one exception to the warning is aspirin.

11 May, 2015

FDA clears Neuroderm clinical trials

Makes Statement

The FDA clears Israeli pharmaceutical firm NeuroDerm’s U.S. clinical studies to proceed in the second half of this year.

Having lifted the clinical hold in the first half of 2015 means that our U.S. clinical development program of ND0612H and ND0612L is proceeding on track. Parkinson’s patients have been hoping for a less invasive, non-surgical alternative that can deliver levodopa continuously. We remain committed to the execution of our plan to bring these product candidates to the market as soon as possible, and to make a significant impact on the lives of Parkinson’s patients.

9 May, 2007

Parkinson’s patch approved


The FDA approves Neupro, the first skin patch designed to treat symptoms of early Parkinson’s disease. Neupro patches, which are changed daily, deliver a drug called rotigotine through the skin. Rotigotine is a member of a class of drugs called dopamine agonists, which mimic dopamine’s effects.


FDA approval


The FDA announces the approval of Neupro, the first skin patch designed to treat symptoms of early Parkinson’s disease. Neupro patches, which are changed daily, deliver rotigotine through the skin. Rotigotine is a member of a class of drugs called dopamine agonists, which mimic dopamine’s effects.

17 May, 2006

FDA approves Azilect


The FDA approves Azilect (rasagiline), a new molecular entity, for the treatment of Parkinson’s disease. The drug is a monoamine oxidase type-B (MAO-B) inhibitor that blocks the breakdown of dopamine, a chemical that sends information to the parts of the brain that control movement and coordination. Dr. Steven Galson, Director of the Center for Drug Evaluation and Research, says:

This is a welcome development for the more than 50,000 Americans who are each year diagnosed with Parkinson’s disease. Parkinson’s is a relentless disease with limited treatment options, and each new therapy is an important addition to the physicians’ treatment options.

13 Jun, 2003

FDA appoval


Novartis announces that the FDA has approved Stalevo (carbidopa, levodopa and entacapone) tablets for patients with idiopathic Parkinson’s disease (PD) who experience signs and symptoms of end-of-dose “wearing off.” Stalevo contains levodopa, the most widely used agent for Parkinson’s disease, plus carbidopa and entacapone. While carbidopa reduces the side effects of levodopa, entacapone extends its benefits, permitting Parkinson’s disease patients to have an improved ability to perform everyday tasks and a reduction in symptoms associated with the disease.

Levodopa is recognized as the cornerstone of Parkinson’s disease therapy, but its long-term use is limited by its reduced ability to fully control Parkinson’s disease symptoms. By blocking the enzymatic breakdown of levodopa, Stalevo provides more levodopa to the brain for a longer period of time. Potential patient benefits include more “on” time during which Parkinson’s symptoms are well-controlled and daily activities are improved, and simpler, more convenient dosing.


FDA approves DBS


The Federal Food and Drug Administration approves deep brain stimulation (DBS) for Parkinson’s disease (PD). According to NIH National Institute of Neurological Disorders and Stroke:

DBS is a surgical procedure used to treat disabling motor symptoms of PD, such as tremor, rigidity, stiffness, slowed movement and walking problems. The DBS system consists of the lead, the extension, and the IPG. The lead—a thin, insulated wire also called an electrode—is inserted through a small opening in the skull and implanted in the brain. The tip of the electrode is positioned within a specific brain area. The implantable pulse generator (IPG)—similar to a heart pacemaker—delivers electrical stimulation to specific areas in the brain that control movement. Once the system is in place, electrical impulses are sent from the IPG up along the extension wire and the lead and into the brain. These impulses block abnormal electrical signals and alleviate PD motor symptoms.

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