FDA Cites 70% of Dietary Supplement Firms on GMPs

FDA GMP Inspectors Cite 70% of Dietary Supplement Firms:

"During a three-year period, federal inspectors have cited seven out of 10 facilities that make dietary supplements for violating regulations intended to ensure products are safe and contain the ingredients that are listed on the labels.

A total 444 out of 626 inspections for cGMPs (current Good Manufacturing Practices) resulted in the issuance of a "Form 483," according to data Natural Products INSIDER obtained through a Freedom of Information Act (FOIA) request."

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Dirty Medicine - A Fortune Feature - A Must Read!

This is a must-read . . .

Dirty medicine - Fortune Features:

"On May 13, Ranbaxy pleaded guilty to seven federal criminal counts of selling adulterated drugs with intent to defraud, failing to report that its drugs didn't meet specifications, and making intentionally false statements to the government. Ranbaxy agreed to pay $500 million in fines, forfeitures, and penalties -- the most ever levied against a generic-drug company."

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Sex Supplements - Containing Viagra; Other Issues

Sex supplements often contain Viagra ingredients | Reuters:

"Herbal supplements aimed at improving men's sexual abilities often contain the active ingredients in erectile dysfunction pills such as Viagra, according to a new study.

Additionally, researchers found that some of these over-the-counter herbal remedies contained more of the ingredient than is allowed in prescription-only pharmaceuticals."

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What The CDC Says About Prescription Drug Abuse - Top 10 List

Follow the link below, and read on . . .

Prescription Drug Abuse: Top 10 Things CDC Says You Should Know | PBS NewsHour:

" . . . the CDC has compiled a list of 10 things you should know about prescription drug abuse. . . . "

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Growing Anger Against The Pharmaceutical Industry

We The People vs. The Pharmaceutical Industry - Forbes:

". . . All this adds up to a giant pushback against the astronomical drug prices that are becoming commonplace. It seems that price tags of $100,000 or above are becoming the norm. Of 12 cancer drugs approved in 2012, 11 cost more than that. As more drugs are offered at that level and their sponsors get away with it, it seems to set a floor that emboldens drug companies to push the envelope. They are badly misjudging the brewing anger. . . ."

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Supplements Involved in Half of Drug Recalls

Supplements Involved in Half of Drug Recalls:

"Analysis of FDA data showed 51% of Class I recalls over a 9-year period involved adulterated dietary supplements instead of a pharmaceutical product, Ziv Harel, MD, of St. Michael's Hospital in Toronto, and colleagues reported in a Research Letter published online in JAMA Internal Medicine.

Most of those supplements were either sexual-enhancement, body-building, or weight-loss aids, they reported."

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FDA Warns - DMAA for Wt Loss & Performance Could Be Dangerous

Consumer Updates > Stimulant Potentially Dangerous to Health, FDA Warns:

"The ingredient, DMAA, is most commonly used in supplements promising weight loss, muscle building and performance enhancement; it can elevate blood pressure and could lead to cardiovascular problems, including heart attack, shortness of breath and tightening of the chest. Given the known biological activity of DMAA, the ingredient may be particularly dangerous when used with caffeine."

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SharedClarity Evaluates Implanted Medical Device Effectiveness

Three Large Health Systems and UnitedHealthcare Launch SharedClarity, a New Venture to Study Long-Term Effectiveness of Medical Devices | Business Wire:

"Three large U.S. health systems and one of the nation’s largest health benefits companies today launched a new venture to conduct independent studies on the long-term effectiveness of medical devices that are implanted into patients for everything from heart problems to bad knees and hips.   

“SharedClarity was formed to help our members deliver high-quality care to their patients”

The new venture, called SharedClarity, includes Dallas-based Baylor Health Care System, San Francisco-based Dignity Health, and Illinois-based Advocate Health Care, along with UnitedHealthcare."

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Shingles Vaccine for Seniors

Hmmm, my posts are starting to show my age ;)

Shingles Vaccine Works in Older Adults:

"The CDC recommends that all individuals 60 and older receive the shingles vaccine -- which is approved for use in those 50 and older -- although immunosuppression is a contraindication to vaccination. "Given that [immunosupressed] individuals are at greatest risk of both herpes zoster and complications, [the current findings] may have important implications for policy," the researchers wrote."

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Food Companies Must Prep For FDA & FSMA

FDA’s Changing Culture: What Every Food Company Needs to Know - Food Safety Magazine:

"Implications for Food Companies - Thus, FDA has demonstrated increased or renewed interest in using a number of its enforcement tools, including inspections, Import Alerts, Warning Letters, actions for injunction and criminal liability under the Park doctrine. FSMA requires FDA to conduct more frequent inspections and gives it authorities for mandatory recalls and suspension of registration. Clearly, companies must recognize and adjust to FDA’s changing culture."

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Find Open Pharmacies In Disaster Areas - About Rx Open

I just learned about Rx Open. It's a very cleverly designed tool to help people find pharmacies that are open. Now that I live in a hurricane prone part of the country, these kind of tools are catching my eye.

About Rx Open:

"... enables patients to be able to locate nearby open pharmacies in a disaster impacted area, Rx Response created Rx Open (formerly called the Pharmacy Status Reporting Tool).

This powerful online tool maps the location of open pharmacies using Google Maps, and also shows which pharmacies are closed and those whose status is unknown. This tool not only helps citizens locate open pharmacies following a major emergency,"

'via Blog this'

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Olive Oil Aroma Might Make You Feel Full

Olive oil the key to feeling full? | ScienceBlog.com:

“Our findings show that aroma is capable of regulating satiety,” concludes Schieberle. “We hope that this work will pave the way for the development of more effective reduced-fat food products that are nonetheless satiating.”

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How To Select A GMP Consultant - Free Tips

The following linked article offers some nuggets to consider when looking at prospective consultants.

7 Tips to Hire a Top GMP Consultant:

"Due to all the layoffs in the pharma industry in recent years, we have seen a flood of new consultants in the pharmaceutical field. We’ve talked to quite a few experienced hands in the industry and this is what they tell us to do to hire the best GMP consultant: . . . "

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Pharma & Pers Care Products - In The Top 10 Most Counterfeited

The 10 Most Counterfeited Products - Business Insider:

An estimated $83 million worth of pharmaceuticals and personal care products were seized in 2012, down from nearly $142 million just a year earlier.

China was responsible for most of the seized counterfeit drugs and personal care items, with an estimated $46.9 million worth of products.

You might also be interested in:
Customs and Border Protection - Seizure Statistics

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FDA 101 Digital Health Guide - Free Rock Health Report

Does your mobile health app need FDA clearance? Checklist gives guidance for digital health entrepreneurs | MedCity News:

In a report dubbed “FDA 101,” health startup accelerator Rock Health has compiled a handy report to help digital health entrepreneurs assess whether their mobile health apps would be classified as medical devices by the FDA and require 510(k) clearance. Rock Reports - FDA 101 - A guide for digital health entrepreneurs

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