Friday, March 29, 2013

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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Thursday, March 28, 2013

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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Wednesday, March 27, 2013

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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GAO Makes Dietary Supplements AERs Recommendations to FDA

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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Sunday, March 24, 2013

Big Pharma Should Use Some Silicon Valley Techniques

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."
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Saturday, March 23, 2013

Medical Device Tax Repeal Applauded

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.”"

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

Updated August 13, 2016

The original video is apparently no longer available

You might also be interested in this FDA resource:
Egg Safety: What You Need to Know
Barbecue Basics: Tips to Prevent Foodborne Illness

- -  original post follows below  - -

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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Thursday, March 21, 2013

Kids Getting Into Medicines At Alarming Rate (video)



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."

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Wednesday, March 20, 2013

FDA Says, Be Safe - Know Your Online Pharmacy

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.



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Tuesday, March 19, 2013

New Recommendations - Child Food Allergy Prevention

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:

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FDA Changes Its Food Webpages

News & Events > Learn About the Changes to FDA.gov/Food:

"Welcome to FDA.gov/Food. If you have used this website before, you may have noticed that we’ve made some changes since your last visit. This page explains why we made changes to the Food section of FDA.gov. It also highlights the major changes so that you can quickly navigate to some of our most popular content.


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Saturday, March 16, 2013

Mobile Usage While Driving - Increasing In The US

My latest pet peeve, seeing people driving while on the phone or using their phone.

The Distracted American Driver - NYTimes.com:

"Despite increasing media attention and laws forbidding the practice, more Americans than ever are using their cellphones to talk and send text messages while driving, a new study shows.

According to the research, nearly 70 percent of Americans ages 18 to 64 said they had chatted on their phones while driving in the past 30 days, and about 30 percent said they had sent text messages while behind the wheel. Drivers in seven European countries were also included in the study, and the numbers showed that the practice appears to be far more common in the United States than overseas."

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Read the findings of the study that's referenced above:
Mobile Device Use While Driving — United States and Seven European Countries, 2011 - MMWR March 15, 2013 / 62(10);177-182

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Wednesday, March 13, 2013

New EU GDP Guidelines Published

Quality and integrity of medicinal products are key factors that must be maintained during the entire supply chain from the manufacturer to the patient. The European Commission revised the guidelines that lay down appropriate tools to assist wholesale distributors in conducting their activities and to prevent falsified medicines from entering the legal supply chain.

Wholesale distribution of medicinal products is defined as "all activities consisting of procuring, holding, supplying or exporting medicinal products, apart from supplying medicinal products to the public. Such activities are carried out with manufacturers or their depositories, importers, other wholesale distributors or with pharmacists and persons authorized or entitled to supply medicinal products to the public in the Member State concerned."

The revised EU GDPs, Good Distribution Practices, become effective September 8, 2013.
Guidelines of 7 March 2013 on Good Distribution Practice of Medicinal Products for Human Use (2013/C 68/01)

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Tuesday, March 12, 2013

What Should I Expect During An Inspection? - FDA Basics

FDA Basics for Industry > What should I expect during an inspection?:

"FDA may conduct an inspection of your operation for a variety of reasons, such as a routinely scheduled investigation, a survey, or a response to a reported problem. The investigator will present credentials and "Notice of Inspection" (FDA Form 482) upon arriving at your plant. A knowledgeable person in your firm, such as the plant or production manager, preferably designated ahead of time, should accompany the investigator at all times. It is in your best interest to fully understand FDA's inspection procedures. When you are unsure of certain actions taken by the investigator, don't hesitate to ask questions." . . .

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You might also be interested in:
Surviving An FDA Inspection - A live, in-person, onsite, in-plant course

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Monday, March 11, 2013

FDA Focusing On Food & Drug Manufacturing GMP Compliance

FDA is focusing on cGMP compliance by food and drug manufacturers.

FDA investigative chief eyes manufacturing practices:

"John Roth, director of the FDA's Office of Criminal Investigations, said officials are seeking to ensure that companies are appropriately balancing their profit motives with the need to manufacture food and drugs responsibly.

The meningitis outbreak and other recent cases have spurred the agency to take a closer look at this balance, Roth told lawyers at an American Bar Association-sponsored conference in Las Vegas focused on white-collar crime.

"We wonder exactly if this is a systemic problem, if it requires a broader response by the FDA or is it an anomaly," Roth said in a panel discussion Friday. "We're going to be taking a look at that and hopefully we'll launch in a thoughtful way.""

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You might also be interested in:
On the FDA website - FD&C Act Chapter III: Prohibited Acts and Penalties

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Friday, March 8, 2013

What Sequestration Means To The FDA - by FDA Matters

This is a good article that highlights what Sequestration means to the FDA.

Funding Cutbacks at FDA: A Sequester Primer « FDA Matters:

" . . .  If food is less safe…if drug and devices reviews go more slowly….if problems with imports increase….and if regulatory science and agency modernization stall….then there is a huge loss to the American people.

This loss is made larger by the knowledge that the agency’s mission is not static.  Congress has passed 6 new laws since 2009 giving FDA substantially more responsibility. Globalization and complex science makes the agency’s job larger and more difficult each year.

FDA staff wasn’t large enough to get the whole job done last year. Problems will  multiply quickly over the coming months as existing employees represent an every smaller proportion of the numbers needed to carry out this year’s and next year’s responsibilities."

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FDA and Tobacco Industry - The Tension & Next Steps

Updated 1/18/2016:
You might be interested in:
FDA's Smoking Prevention Campaigns: Reaching Teens Where They 'Live'

Updated 10/30/2015
You might've been looking for:
E-cig firms steel for legal battle
FDA Acts to Shut Down Tobacco Sales at Stores That Sell to Minors

= = original post below = =

FDA's New Tobacco Scheme, and its Legislative Underpinnings, May Go Up in Smoke - Forbes:

"Several years ago, the federal government entered into a Faustian bargain with the tobacco industry — and the cigarette makers with the government. It was legislation borne of mutual antipathy.

Under the scheme, Washington brought the tobacco industry under the thumb of federal regulation. FDA now oversees everything from the way cigarettes are marketed, to the manner in which they are made. In exchange, the tobacco industry was promised a regulatory track out of their current (declining) business model.

FDA was to create a path to enable cigarette makers to transition away from smoked tobacco and win government approval of consumable products that used tobacco but presumably harbored less, and perhaps even none of the health risks posed by smoking. "

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Learn more about an upcoming March 2013 workshop:
FDA - Third Party Governance of Industry-Sponsored Tobacco Product Research - A Public Workshop

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Thursday, March 7, 2013

FDA Asked About Mobile Apps and the FDA 510K Process

Congress asks FDA if “actual use” is factor in medical app regulation | mobihealthnews:

". . . The letter also asks whether the FDA will consider the “actual use” of a mobile medical app in addition to the “intended use” when making its determination about whether an app needs to go through the 510(K) process. Finally, the letter closes with a series of questions related to the final guidance document and the committee wants answers by March 15th."

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Read the Letter Sent to FDA Commissioner Margaret Hamburg (pdf)

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FDA Free Tips - Don't Fall for Health Fraud Scams (video)

Consumer Updates > 6 Tip-offs to Rip-offs: Don't Fall for Health Fraud Scams:

"In this video, FDA Commissioner Margaret A. Hamburg, M.D., and FDA National Health Fraud Coordinator Gary Coody, R.Ph., discuss health fraud and tips for avoiding scams."



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Learn more about health fraud scams from the FDA:  Health Fraud Scams (FDA)
"Health fraud scams refer to products that claim to prevent, treat, or cure diseases or other health conditions, but are not proven safe and effective for those uses. Health fraud scams waste money and can lead to delays in getting proper diagnosis and treatment. They can also cause serious or even fatal injuries."

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Monday, March 4, 2013

FDA Intro To The FSMA (video)

The FDA Food Safety Modernization Act (FSMA) video explains how the new law makes prevention from farm to table the basis of food safety.



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FDA Facts About Current Good Manufacturing Practices (cGMPs)

If you're new to the FDA's cGMPs, then follow the link below, to their website. It explains what the cGMPs are all about:

Manufacturing > Facts About Current Good Manufacturing Practices (cGMPs):

"Current Good Manufacturing Practices (cGMPs) for human pharmaceuticals affect every American.  Consumers expect that each batch of medicines they take will meet quality standards so that they will be safe and effective.  Most people, however, are not aware of cGMPs, or how FDA assures that drug manufacturing processes meet these basic objectives.  Recently, FDA has announced a number of regulatory actions taken against drug manufacturers based on the lack of cGMPs.  This paper discusses some facts that may be helpful in understanding how cGMPs establish the foundation for drug product quality.

What are cGMPs?" . . .

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