Heartburn can be said as a disease of “a million people” money often makes the sufferer’s activities disrupted. The reason is, when this disease recurs, there will be pain that makes the stomach feel twisted, making the sufferer wince in pain.

Heartburn can be caused by several things, one of which is excess acid in the stomach. This condition can attack the lining of the stomach to cause pain.

In addition, heartburn can be caused by infection of the stomach by the bacterium Helicobacter pylori, and chronic use of nonsteroidal anti-inflammatory drugs (NSAIDs), such as aspirin. The question is, how to prevent ulcer disease?

Tips for Preventing Ulcer Recurrence
Actually, experts don’t know for sure how Helicobacter pylori spreads or why some people develop ulcer disease without being infected by the H. pylori bacteria. This makes prevention may be difficult to do.

However, fortunately there are efforts that can be … Read more

There are a few different approaches to FDA submission. Those seeking to develop and market a new drug or device may consider a Pre-submission. Other requests include 510(k) expansion or abbreviated compliance. Below are the steps involved in these processes.

Pre-submission

If you’re about to submit a new medical device to the FDA, conducting a Pre-Submission for FDA review is essential. Pre-Submission meetings can take place face-to-face or through teleconference, and the type of medical device typically defines them and the questions FDA staff will be asking during the review. However, a well-planned conference call can be just as effective. Here are some tips to help you prepare for a Pre-Sub meeting with the FDA.

510(k)

The FDA must approve a 510(k) submission. Once approved, the request will be added to the FDA’s database. This database is updated every week. In addition, the SE letter and the IFU and … Read more