Swimmer’s ear isn’t just for swimmers. It’s only named ‘swimmer’s ear’ because swimmers tend to experience it more than other people. But the fact is that swimmer’s ear can happen to anyone; just because you’re not a swimmer, don’t expect to be immune from it. The website of the Mayo Clinic defines swimmer’s ear, simply, as an infection in the outer ear canal. (The outer ear canal is that part of the ear’s structure which runs from your eardrum to the outside of your head.) So, if you have ears, you can get swimmer’s ear, and you don’t have to swim to get it. Do you take showers or baths? Do you wash your hair? Do you ever find yourself caught in the rain or in humidity? Do you use headphones or clean your ears with cotton swabs? If you answered ‘yes’ to any of these questions (and hopefully you did, especially the shower/bath thing), then you can be prone to these infections of the outer ear canal that are also known as ‘swimmer’s ear.’ Continue reading
MHRA stands for the Medicines and Healthcare Products Regulatory Agency, which is a major force in the healthcare landscape of the United Kingdom. Public health is very import and the MHRA has a big hand in regulating the marketplace as well as steering public health policy. Medicine is always developing and new technologies and medicines are continuously being developed and brought to market. These products are designed to treat many health problems, often in new and innovative ways. All of these products must be thoroughly tested and their quality and safety must be monitored constantly in order to keep the public safe. The Medicines and Healthcare Products Regulatory Agency or MHRA is the government agency that is in charge of all of the extensive testing that is necessary for a new product to be brought to market. The MHRA also controls pharmaceutical compliance as well as medical device compliance in the UK. Continue reading
If you have never had a cavity, you may be clueless as to how the dentist actually treats this problem. By understanding exactly what a cavity is and how your dentist is going to resolve the issue, you can be prepared for the experience. Here is the information that you need to know so you know exactly what to expect if during your next dental office visit a cavity is found. Continue reading
TMJ, or the temporomandibular joint, is like a sliding hinge that connects your jaw bone to the rest of your body. Temporomandibular joint disorders can cause a lot of pain in your jaw joint and in the muscles controlling your jaw’s movements. Here is some information about the temporomandibular joint you should know if you’re having any problems. Continue reading
There are many ways to prevent and cover up bad breath. It is important to know what is causing your bad breath to know what will work best in your situation. There are a variety of things that can be causing it that should be fixed in order to stop bad breath from returning. Here are some causes of bad breath and ways that you can prevent it from returning in the future. Continue reading
His Excellency, the Governor General in Council, by the recommendation of the Minister of Health, pursuant to the Food and Drug Act, brought forth what was meant to be an answer to a common problem. Medical devices that were sold in Canada needed to be researched and regulated for the safety of the users. Regulations got passed that apply that the sale and advertising of medical devices, and the importation of medical devices. The rules also apply to in vitro diagnostic tools or products, as if the product were an in vitro diagnostic device themselves. Food and Drug Regulations, Controlled Drugs and Substances Act, and the Narcotic Control Regulations all state pretty clearly that you are to stay away from illegal and non-prescribed drugs. Continue reading
In America, the FDA’s Center for Devices and Radiological Health, or CDRH, is responsible for regulating the firms that manufacture, repackage, relabel, or import medical devices that are sold in the United States. It also regulates electronic products that emit radiation. These products include lasers, x-rays, ultrasounds, microwaves, and color televisions.
Radiation-emitting Electronic Products
Medical devices are broken down into three classes, Class I, Class II, and Class III. Class I has the least amount of regulatory control and are exempt from having to submit a Pre-market Notification 510(k) for approval. Class II devices; however, require Pre-market Notification 510(k). Class III devices require Pre-market Approval and the approval of two groups. Continue reading
If you are trying to market a medical device, the Food and Drug Administration, or FDA, must clear your product for medical compliance. There is a rigorous process and there are fees involved as well. Medical devices can fall under three separate classes that are relevant to the FDA compliance approval process, and, in the following, they are explained in much greater detail. Getting a medical device approved can be done a couple of different ways.
After you put together your creation, you must determine what classification it is. The three classes are simply known as class I, II, and III. What property earns the devices this classification is usually the risk it offers users. The lowest level, class I, is associated with devices that are not harmful to consumers in any way. Tongue depressors and thermometers are both types of class I devices. These have a relatively easy procedure to follow to get approved by the FDA. Continue reading
Companies that make drugs are always analyzing various compounds trying to find the ones that have the most therapeutic value. There are many steps, millions of dollars, and thousands of man hours spent on trying to get a medicine approved by the FDA. There are many steps to get your product approved before you can sell it on the open market.
Perfection and Preclinical Testing
During the first six or seven years of preclinical testing the synthesis and purification of a drug gets perfected by the manufacturer. Limited animal testing applies as well. Out of thousands of compounds that are tested, only a few will appear to have enough promise to induce a company to file an IND, or Investigational New Drug Application. If the FDA approves the IND and an Institutional Review Board approves them as well, the manufacturer can start the first part of development. Continue reading
An Electronic Common Technical Document, or eCTD, is a standard for electronic submission containing regulating information to regulated agencies. The document is an easy and quick resource that you can get a lot from using.
Where is eCTD currently accepted?
Regulating agencies that account for all of separate areas, including United States, Canada, the European Union, and Japan, all have accepted eCTD submission. They have set in place good medicinal compliance and device compliance that works to not harm the patient. Continue reading