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FDA - Unusual Letter Sent To iPhone-Based Testing Device Co

noreply@blogger.com (Austin Lee) — Fri, 24 May 2013 11:08:00 +0000

FDA Sends Unusual Letter to Maker of iPhone-Based Testing Product:

"(FDA) revealed that it had sent off another type of letter to a medical device company, one rarely publicized by the agency." . . .

"Prior FDA explanations make clear that the letters are part of a "triage" strategy practiced by the agency's device regulators in which the "It Has Come To Our Attention" letter follows a "call to clarify," preceding further actions such as an Untitled Letter, Inspection or Warning Letter."

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Ten FDA 483s Summarized by FDAzilla Blog

noreply@blogger.com (Austin Lee) — Fri, 24 May 2013 10:52:00 +0000

Follow the link below to read FDAzilla Blog's overview of 10 recent 483s.

10 FDA 483 News Stories | FDAzilla Blog:

"Here’s 10 recent stories that have hit our radar related to FDA 483s: . . . "

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FDA - Don't Represent Dietary Supplements As Foods

noreply@blogger.com (Austin Lee) — Wed, 22 May 2013 11:50:00 +0000

FDA: Dietary Supplements Can't be Marketed as Foods:

" . . . If nothing else, it is a very good reminder that you must be extremely careful making any representations about your product, not just the claims on the label," Prochnow said in an email Tuesday to the media. "Claims on websites and in other marketing and advertising can and will be used by FDA as evidence of the company's true intent to sell the product.""

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FDA Cites 70% of Dietary Supplement Firms on GMPs

noreply@blogger.com (Austin Lee) — Tue, 21 May 2013 03:42:00 +0000

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!

noreply@blogger.com (Austin Lee) — Fri, 17 May 2013 11:36:00 +0000

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

noreply@blogger.com (Austin Lee) — Mon, 13 May 2013 10:57:00 +0000

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

noreply@blogger.com (Austin Lee) — Tue, 30 Apr 2013 19:29:00 +0000

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

noreply@blogger.com (Austin Lee) — Tue, 30 Apr 2013 12:55:00 +0000

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

noreply@blogger.com (Austin Lee) — Wed, 17 Apr 2013 11:42:00 +0000

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

noreply@blogger.com (Austin Lee) — Fri, 12 Apr 2013 13:57:00 +0000

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

noreply@blogger.com (Austin Lee) — Wed, 10 Apr 2013 12:40:00 +0000

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

noreply@blogger.com (Austin Lee) — Wed, 10 Apr 2013 12:24:00 +0000

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

noreply@blogger.com (Austin Lee) — Mon, 08 Apr 2013 21:51:00 +0000

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

noreply@blogger.com (Austin Lee) — Sat, 06 Apr 2013 15:11:00 +0000

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

noreply@blogger.com (Austin Lee) — Fri, 29 Mar 2013 11:53:00 +0000

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

noreply@blogger.com (Austin Lee) — Thu, 28 Mar 2013 13:25:00 +0000

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: . . . "

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

noreply@blogger.com (Austin Lee) — Wed, 27 Mar 2013 16:54:00 +0000

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

noreply@blogger.com (Austin Lee) — Wed, 27 Mar 2013 12:55:00 +0000

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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GAO Makes Dietary Supplements AERs Recommendations to FDA

noreply@blogger.com (Austin Lee) — Wed, 27 Mar 2013 12:25:00 +0000

U.S. GAO - Dietary Supplements: FDA May Have Opportunities to Expand Its Use of Reported Health Problems to Oversee Products:

GAO recommends, among other things, that FDA explore options to obtain poison center data, if determined to be useful; collect information on how it uses AERs; provide more information to the public about AERs; and establish a time frame to finalize guidance related to GAO's 2009 recommendations. FDA generally concurred with each of GAO's recommendations.

Read the full GAO Report (PDF):
DIETARY SUPPLEMENTS - FDA May Have Opportunities to Expand Its Use of Reported Health Problems to Oversee Products

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Big Pharma Should Use Some Silicon Valley Techniques

noreply@blogger.com (Austin Lee) — Sun, 24 Mar 2013 11:59:00 +0000

I enjoyed reading the article below. It was interesting and struck a chord for me.

Strategy: Why Big Pharmas Do What They Do -- And How Silicon Valley Might Help Them Think Differently - Forbes:

"The aggressive application of emerging analytic and digital health technologies, while currently viewed as “nice to have” at best, are likely to emerge as table stakes in a world focused on the more precise identification and delineation of value."

Medical Device Tax Repeal Applauded

noreply@blogger.com (Austin Lee) — Sat, 23 Mar 2013 13:09:00 +0000

Medical Device Manufacturing Coalition Applauds Passage of Medical Device Tax Repeal Amendment | MedicalDevices.org:

"“Today’s overwhelming support of the amendment shows that clear majorities in the Senate and the House of Representatives recognize that the medical device tax needs to be repealed so that America’s medical technology community can spur growth and create the great jobs that come along with it,” said Mark Leahey, President and CEO of MDMA. “Every day innovators in this dynamic industry are looking at how to improve the quality of life for patients, and the medical device tax is standing in the way of progress and threatening America’s leadership position. While we have more work to do, MDMA applauds this important step towards ensuring that the United States remains the global leader in medical technology innovation.”"

'via Blog this'

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FDA On Eggs - Easter & Spring Food Safety (video)

noreply@blogger.com (Austin Lee) — Sat, 23 Mar 2013 12:34:00 +0000

Eating eggs that are not handled with proper care can cause food poisoning, also called foodborne illness. Salmonella, an organism that causes nausea, vomiting, diarrhea, cramps, and fever, can be found on both the outside and the inside of eggs that look perfectly normal.

Stay safe this Spring and holiday season.

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Kids Getting Into Medicines At Alarming Rate (video)

noreply@blogger.com (Austin Lee) — Thu, 21 Mar 2013 10:54:00 +0000

500,000 Times Each Year a Child gets into Medicine or gets the Wrong Dose:

"Safe Kids Worldwide released a new research report that found kids are getting into medicine at an alarming rate. Every minute of every day, a poison control center receives a call about a potential medicine poisoning for a child age five and under. And 67,000 times each year, or every eight minutes, a young child goes to the emergency room for medicine poisoning. This is a 30 percent increase over the past ten years."

'via Blog this'

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FDA Says, Be Safe - Know Your Online Pharmacy

noreply@blogger.com (Austin Lee) — Wed, 20 Mar 2013 12:08:00 +0000

The FDA is raising awareness of the dangers of buying prescription medicines from fake online pharmacies. Their BeSafeRx campaign provides the resources to help consumers.

The following short video explains why you should care, and how to protect yourself.

You might also be interested in:

The FDA's BeSafeRx Webpage

New Recommendations - Child Food Allergy Prevention

noreply@blogger.com (Austin Lee) — Tue, 19 Mar 2013 12:23:00 +0000

A committee from the American Academy of Asthma, Allergy, and Immunology (AAAAI) published new recommendations for parents aimed at helping prevent food allergies in young children.

Primary Prevention of Allergic Disease Through Nutritional Interventions. The Journal of Allergy and Clinical Immunology: In Practice. Volume 1, Issue 1 , Pages 29-36, January 2013

The journal article above, is pretty detailed and isn't a casual quick read. The following might be a better quick introductory article:

New Thinking On Preventing Food Allergies (Parade Magazine)