Random Number Generation

In response to public concerns about cryptographic security, the National Institute of Standards and Technology (NIST) has formally revised its recommended methods for generating random numbers, a crucial element in protecting private messages and other types of electronic data. The action implements changes to the methods that were proposed by NIST last year in a draft document issued for public comment.

For more information: Random Number Generation

Disclaimer: The EDC Developer blog is “one man’s opinion”. Anything that is said on the report is either opinion, criticism, information or commentary. If making any type of investment or legal decision it would be wise to contact or consult a professional before making that decision

HIV Vaccine Progress in Animal Studies

Research teams achieved important steps needed to prompt the immune system to produce antibodies against HIV. The results show important progress toward design of an effective HIV vaccine.

Source: FDA

Disclaimer: The EDC Developer blog is “one man’s opinion”. Anything that is said on the report is either opinion, criticism, information or commentary. If making any type of investment or legal decision it would be wise to contact or consult a professional before making that decision

New and Generic Drug Approvals

Recent Drug Approvals

New and Generic Drug Approvals

June 25, 2015

Drug Name Active Ingredient Dosage Form/Route Sponsor Submission Type
Amyvid florbetapir f-18 Solution;Intravenous Avid Radiopharms Inc Manufacturing Change or Addition
Banzel rufinamide Tablet;Oral Eisai Inc Labeling Revision
Banzel rufinamide Suspension;Oral Eisai Inc Labeling Revision
Cabazitaxel cabazitaxel Injectable;Injection Accord Hlthcare Inc Tentative Approval
Zuplenz ondansetron Film;Oral Galena Biopharma Inc Manufacturing Change or Addition

For more information go to FDA

Disclaimer: The EDC Developer blog is “one man’s opinion”. Anything that is said on the report is either opinion, criticism, information or commentary. If making any type of investment or legal decision it would be wise to contact or consult a professional before making that decision

Assessment of Radiofrequency-Induced Heating in the Magnetic Resonance Environment for Multi-Configuration Passive Medical Devices

Assessment of Radiofrequency-Induced Heating in the Magnetic
Resonance Environment for Multi-Configuration Passive Medical Devices;
Draft Guidance for Industry and Food and Drug Administration Staff;
Availability

This draft guidance is being issued consistent with FDA's good 
guidance practices regulation (21 CFR 10.115). The draft guidance, when 
finalized, will represent the current thinking of FDA on the assessment 
of RF-induced heating of multi-component, or multi-configuration, 
passive medical devices in the MR environment. It does not establish 
any rights for any person and is not binding on FDA or the public. You 
can use an alternative approach if it satisfies the requirements of the 
applicable statutes and regulations.

For more inforamtion go to FDA

New Schizophrenia Drug – Rexulti

FDA approves new drug to treat schizophrenia and as an add on to an antidepressant to treat major depressive disorder

On July 10, the U.S. Food and Drug Administration approved Rexulti (brexpiprazole) tablets to treat adults with schizophrenia and as an add-on treatment to an antidepressant medication to treat adults with major depressive disorder (MDD).

Schizophrenia is a chronic, severe, and disabling brain disorder affecting about one percent of Americans. Typically, symptoms are first seen in adults younger than 30 years of age and include hearing voices; believing other people are reading their minds or controlling their thoughts; and being suspicious or withdrawn.

 MDD, commonly referred to as depression, is also a severe and disabling brain disorder characterized by mood changes and other symptoms that interfere with a person’s ability to work, sleep, study, eat, and enjoy once-pleasurable activities. Episodes of depression often recur throughout a person’s lifetime, although some may experience a single occurrence. Other signs and symptoms of MDD include loss of interest in usual activities; significant change in weight or appetite; insomnia or excessive sleeping (hypersomnia); restlessness/pacing (psychomotor agitation); increased fatigue; feelings of guilt or worthlessness; slowed thinking or impaired concentration; and suicide attempts or thoughts of suicide. Not all people with MDD experience the same symptoms.

The effectiveness of Rexulti in treating schizophrenia was evaluated in 1,310 participants in two 6-week clinical trials. Rexulti was shown to reduce the occurrence of symptoms of schizophrenia compared to placebo (inactive tablet).

The effectiveness of Rexulti as an add-on treatment for MDD was evaluated in two 6-week trials that compared Rexulti plus an antidepressant to placebo plus an antidepressant in 1,046 participants for whom an antidepressant alone did not adequately treat their symptoms. The participants taking Rexulti reported fewer symptoms of depression than those taking the placebo.

For more information please visit: Rexulti

Disclaimer: The EDC Developer blog is “one man’s opinion”. Anything that is said on the report is either opinion, criticism, information or commentary. If making any type of investment or legal decision it would be wise to contact or consult a professional before making that decision

Cervical spine injury medical treatment guidelines

Source: Colorado Division of Workers’ Compensation

 

Disclaimer: The EDC Developer blog is “one man’s opinion”. Anything that is said on the report is either opinion, criticism, information or commentary. If making any type of investment or legal decision it would be wise to contact or consult a professional before making that decision

FDA approved new drug to treat heart failure

On July 7, 2015 the U.S. Food and Drug Administration approved Entresto (sacubitril/valsartan) tablets for the treatment of heart failure. The drug has been shown to reduce the rate of cardiovascular death and hospitalization related to heart failure.

Heart failure is a common condition affecting about 5.1 million people in the United States. It is a condition in which the heart can’t pump enough blood to meet the body’s needs. Heart failure generally worsens over time as the heart’s pumping action grows weaker. The leading causes of heart failure are diseases that damage the heart, such as heart attacks and high blood pressure.

Entresto is manufactured by Novartis, based in East Hanover, New Jersey.

For more information go to FDA website @FDA

Source: FDA website

Disclaimer: The EDC Developer blog is “one man’s opinion”. Anything that is said on the report is either opinion, criticism, information or commentary. If making any type of investment or legal decision it would be wise to contact or consult a professional before making that decision

FDA strengthens warning that non-aspirin nonsteroidal anti-inflammatory drugs (NSAIDs) can cause heart attacks or strokes

The U.S. Food and Drug Administration (FDA) is strengthening an existing label warning that non-aspirin nonsteroidal anti-inflammatory drugs (NSAIDs) increase the chance of a heart attack or stroke. Based on our comprehensive review of new safety information, we are requiring updates to the drug labels of all prescription NSAIDs. As is the case with current prescription NSAID labels, the Drug Facts labels of over-the-counter (OTC) non-aspirin NSAIDs already contain information on heart attack and stroke risk. We will also request updates to the OTC non-aspirin NSAID Drug Facts labels.

Patients taking NSAIDs should seek medical attention immediately if they experience symptoms such as chest pain, shortness of breath or trouble breathing, weakness in one part or side of their body, or slurred speech.

To learn more, please visit: NSAIDs.

Disclaimer: The EDC Developer blog is “one man’s opinion”. Anything that is said on the report is either opinion, criticism, information or commentary. If making any type of investment or legal decision it would be wise to contact or consult a professional before making that decision