#FDA

With the flood of "Health Apps" on the market, and rapid increase in OTC medical devices (AEDs for one) leading to perhaps-lesser-quality-assurance, the FDA is ramping up its after-market performance scrutiny. According to the FDA: Despite rigorous premarket evaluation, what really counts is how well a medical device works when it’s used day-to-day by patients, caregivers and clinicians. Beyond clinical...

FDA has issued guidelines to give companies that create mobile medical applications, or "apps," a clear and predictable roadmap to help them determine whether or not their apps for smartphones and tablets will be the focus of FDA's oversight. Keeping Up with Progress in Mobile Medical Apps Patients with diabetes can already use smartphones to monitor the level of sugar...

Not the effect one would want from an Asthma relief device ... Manufacturing Defect May Cause Choking Hazard FDA is alerting patients and the medical community to the possibility of a choking hazard in the EZ Breathe Atomizer. This device sprays liquid medication in aerosol form into the air for a person to breathe. Risk: Due to a manufacturing defect...

Mislabeled Aspirin Increases Risk of Liver Damage FDA is alerting consumers, pharmacy and health care professionals to a nationwide recall of one lot of 81 mg Enteric Coated Aspirin Tablets because of the possibility that the tablets in these bottles may actually contain tablets with 500 mg of acetaminophen, the active ingredient in other pain relievers such as Tylenol. The...

Many of today’s important medications are biological products, generally derived from living material from humans, animals, or microorganisms.  These products treat conditions such as rheumatoid arthritis, anemia, low white blood cell counts, inflammatory bowel disease, and various forms of cancer.  Unlike other drugs known as small molecule drugs, biological products are generally highly complex in structure.  This webinar is designed...

Why should you trust that the information listed on food labels is accurate and complete? Because FDA monitors food products to ensure that the labels are truthful and takes appropriate action if they are not. In this Consumer Update, learn what steps FDA takes if it has reason to believe that a food product has been misbranded with information that...