How Congress almost delayed the FDA’s mobile medical app guidance

I can't wait to see what's in the final guidance, when it's finally published.

How Congress almost delayed the FDA’s mobile medical app guidance | mobihealthnews:

"Much has been written in the past few weeks about Congress’ efforts to put its mark on the FDA’s regulation of mobile medical apps. I was curious how this issue of 510(k) clearance for mobile apps became a topic of interest for Congress. The FDA published its draft guidance a year ago now. After hundreds of companies weighed in with their thoughts on the document, the industry widely expects a final guidance document any week now. Why did the Senate take an interest in medical app regulation this past spring? Who asked them to? And, what exactly did their conversation sound like?"

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FDA warns companies to stop making unapproved oxycodone painkiller pills

Companies have been doing what?!

FDA warns companies to stop making unapproved oxycodone painkiller pills - The Washington Post:

"The Food and Drug Administration says it will begin cracking down on companies that market versions of the painkiller oxycodone which have not undergone federal review.

Oxycodone is a powerful pain reliever with the potential for addiction, abuse and death, when used inappropriately. The drug is marketed legally by companies like Purdue Pharma, which sells the time-release pill OxyContin. FDA reviews these drugs to make sure they are safe and effective.

However, other companies have marketed similar pills for years without FDA clearance."

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FDA - Eating Outdoors, Handling Food Safely - Free Tips

Excellent advice from the FDA.  Simple and straightforward tips for outdoor food safety.

Consumers > Eating Outdoors, Handling Food Safely:

"Picnic and barbecue season offers lots of opportunities for outdoor fun with family and friends. But these warm weather events also present opportunities for foodborne bacteria to thrive. As food heats up in summer temperatures, bacteria multiply rapidly.

To protect yourself, your family, and friends from foodborne illness during warm-weather months, safe food handling when eating outdoors is critical. Read on for simple food safety guidelines for transporting your food to the picnic site, and preparing and serving it safely once you've arrived."

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Dietary supplements: Manufacturing troubles widespread, FDA inspections show

The FDA began conducting inspections in 2008 to assess compliance with new regulations governing the manufacturing, packing and holding of dietary supplements. Since then, 1 in 4 dietary supplement companies inspected by the agency have received a warning letter, considered a significant enforcement action.

Dietary supplements: Manufacturing troubles widespread, FDA inspections show | Chicago Tribune:

"Federal inspections of companies that make dietary supplements - from multivitamins and calcium chews to capsules of echinacea and bodybuilding powders - reveal serious and widespread manufacturing problems in a $28 billion industry that sells products consumed by half of all Americans.

In the last four years, the U.S. Food and Drug Administration has found violations of manufacturing rules in half of the nearly 450 dietary supplement firms it has inspected, according to agency officials.

The inspection reports portray an industry struggling to meet basic manufacturing standards, from verifying the identity of the ingredients that go into its products to inspecting finished batches of supplements.

Some firms don't even have recipes, known as master manufacturing records, for their products."

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RAPS - Open Access Month - Free July Access to Regulatory Focus Online

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Updated March 10, 2021

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What a treat!  I'm looking forward to exploring Regulatory Focus.

RAPS > Focus Online > Open Access Month:

"If you are a RAPS member, you already enjoy access to all Regulatory Focus news and in-depth features.

But if you aren’t a member, now is the chance to see what you are missing.

For the month of July, all articles – news, features and departments – are open for all to read. This is your opportunity to get information and insight from regulatory insiders on topics that affect you."

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