Poison-proof your home

poison-proof your home - South Florida Sun-Sentinel.com:

"The top 5 poisons toddlers enjoy placing in their mouths during playtime are:

• Household cleaners
• Medications
• Cosmetics and personal care products
• Foreign objects, such as coins and watch batteries
• Plants, berries and mushrooms"

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A Regulatory App-ening - A mobile apps POV on FDA medical device regulations

Read this well-written point of view regarding the FDA's medical device regulations and how they impact mobile applications . . . are they or aren't they medical devices?!

Drugwonks | A Regulatory App-ening:

" . . . during the session on mobile apps as medical devices. At present, there are some 17,828 healthcare and fitness apps and 14,558 that can be deemed “medical.” As Vice President Biden said, “It’s a big f**kin’ deal.”

But when is an app a medical device and when is it not? Not surprisingly, it depends."

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Essentials for Medical Device Manufacturer - Learn the basics of the FDA's QSR regulations

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Related articles

• Medical device firms growing in South Florida (skillsplusinfo.blogspot.com)
• What to do after a hurricane if you use a home medical device (drughealth.blogspot.com)

What to do after a hurricane if you use a home medical device

• People also search for California Home Medical Device Retailer Exemptee license training certification course - Buy now!

This article has good links off to additional information and resources

What to do after a hurricane if you use a home medical device:

". . . like an oxygen tank, ventilator, medical bed, wheel chair, or blood glucose monitor, losing power can be much more than an inconvenience. Your first step should be to call your electric company and fire department to let them know that you have a medical device that needs power. While you wait for power to be restored or help to come, here's some advice from the U.S. Food and Drug and Administration on what else to do: . . . "

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Compounding pharmacies need FDA oversight

Will Congress step in, to help the FDA?

Compounding pharmacies need FDA oversight - The Washington Post:

. . . Congress gave the FDA some oversight power in 1997 over compounding pharmacies, but several of the firms challenged the law in court. At issue was the FDA’s power to regulate their brochures and advertising. In 2002, the Supreme Court ruled for the pharmacies. Two appellate court decisions since then conflict about whether the original law is valid and enforceable. Congress has failed to clarify the situation. . .

"The federal government, Congress and the states all bear some blame for this lapse of oversight. There are proven methods to prevent contaminated medicine from reaching patients — methods that were simply not used in this case. Congress can remedy the situation by putting the regulation of large-scale drug compounding unequivocally under FDA control. The health and safety of Americans demand that government not fail a second time."

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FDA Statement on NECC Fungal Meningitis Outbreak: Additional Patient Notification Advised

Fda (Photo credit: Wikipedia)

Drug Safety and Availability > FDA Statement on Fungal Meningitis Outbreak: Additional Patient Notification Advised:

"At this point in FDA’s investigation, the sterility of any injectable drugs, including ophthalmic drugs that are injectable or used in conjunction with eye surgery, and cardioplegic solutions produced by NECC are of significant concern, and out of an abundance of caution, patients who received these products should be alerted to the potential risk of infection. At this time, no cases of infection have been reported in connection with any NECC-produced ophthalmic drug that is injectable or used in conjunction with eye surgery, but FDA believes this class of products could present potentially similar risks of infection. Products from NECC can be identified by markings that indicate New England Compounding Center by name or by its acronym (NECC), "

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