Wednesday, July 30, 2014

Quality of Dietary Supplements - QM USP

Read the full article: Quality of Dietary Supplements - QM (Quality Matters) USP:

"In the United States, current Good Manufacturing Practices (cGMPs) for dietary supplements are mandated by law, and the FDA has the authority to oversee dietary supplement companies for compliance with those GMPs. This provision of the law acts to safeguard consumers of some quality issues, helping to keep dietary supplements from becoming adulterated.

However, most quality specifications for dietary supplements in the United States are set by manufacturers with no premarketing oversight and few uniform requirements. For that reason, the quality of dietary supplements may vary significantly from one manufacturer to another.

Moreover, dietary supplements and their ingredients may be manufactured in countries with weaker regulatory systems making it even more difficult to control the quality of dietary supplements imported into our domestic market."

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Smart pill firm Proteus raises $172 million | Reuters

Read the full article: Smart pill firm Proteus raises $172 million | Reuters:

"A U.S. biotech company pioneering tablets containing embedded microchips that can tell if patients have taken their medication has raised a further $172 million, showing investor interest in its ingestible and wearable technology.

Privately held Proteus Digital Health, which is working with drugmakers including Novartis and Otsuka, said on Tuesday the funding was one of the biggest U.S. private financings this year and the largest in the digital health sector.

Proteus already has European and U.S. approval for its "smart pill" technology system, in which a tiny sensor is embedded in a tablet and linked to a patch worn on the patient's abdomen."

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Monday, July 21, 2014

Safety Alerts & Advisories > FDA Consumer Advice on Powdered Pure Caffeine

Read the full alert: FDA Consumer Advice on Powdered Pure Caffeine - FDA.gov:

"Key Message

The FDA is warning about powdered pure caffeine being marketed directly to consumers, and recommends avoiding these products.  In particular, FDA is concerned about powdered pure caffeine sold in bulk bags over the internet.

The FDA is aware of at least one death of a teenager who used these products.

These products are essentially 100 percent caffeine. A single teaspoon of pure caffeine is roughly equivalent to the amount in 25 cups of coffee.

Pure caffeine is a powerful stimulant and very small amounts may cause accidental overdose. Parents should be aware that these products may be attractive to young people.

Symptoms of caffeine overdose can include rapid or dangerously erratic heartbeat, seizures and death. Vomiting, diarrhea, stupor and disorientation are also symptoms of caffeine toxicity. These symptoms are likely to be much more severe than those resulting from drinking too much coffee, tea or other caffeinated beverages."

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Wednesday, July 16, 2014

GMP News: Insufficient failure investigations, supplier qualification, stability testing - the most common GMP violations in the FDA warning letters

Read the full article: GMP News: Insufficient failure investigations, supplier qualification, stability testing - the most common GMP violations in the FDA warning letters:

"The analysis of the warning letters issued in the last fiscal year shows no surprise at a first glance: as in recent years the FDA detected an insufficient investigation of unexplained discrepancies and deviations from defined standards and specifications in their inspections. The corresponding paragraph 21 CFR 211.192 requires that the drug maker clarifies the reason for the deviation, takes corrective actions and also creates a complete documentation. In the last 5-year period on average annually about 22 companies received a warning letter listing this GMP deficiency. This fact shows that many quality assurance departments' understanding of deviations handling, failure investigations and corrective actions is frequently fragmentary."

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Monday, July 14, 2014

Spoonfuls can lead to medicine errors, study finds - US News

Read the full article: Spoonfuls can lead to medicine errors, study finds - US News:

"Parents who used spoonfuls "were 50% more likely to give their children incorrect doses than those who measured in more precise milliliter units," said Dr. Alan Mendelsohn, a co-author and associate professor at New York University's medical school.

Incorrect doses included giving too much and too little, which can both be dangerous, he said. Underdosing may not adequately treat an illness and can lead to medication-resistant infections, while overdoses may cause illness or side effects that can be life-threatening. The study doesn't include information on any ill effects from dosing mistakes."

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Wednesday, July 2, 2014

Buy, Store & Serve Safe Food > Eating Outdoors, Handling Food Safely - FDA.gov

Read the full article: Buy, Store & Serve Safe Food > Eating Outdoors, Handling Food Safely - FDA.gov:

"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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