FDA Notes Primatene Mist Departure

Medical News: FDA Notes Primatene Mist Market Departure - in Product Alert, OTC from MedPage Today:     'via Blog this'

The only over-the-counter asthma inhaler sold in the United States will no longer be available next year as part of a phase-out of epinephrine inhalers containing chlorofluorocarbons (CFCs).

Epinephrine CFC inhalers, marketed as Primatene Mist, are being phased out because they use CFCs as a propellant (spray) to move the medicine out of the inhaler so patients can breathe the medicine into their lungs. 

Primatene Mist is approved by the Food and Drug Administration (FDA) for the temporary relief of occasional symptoms of mild asthma.

If you're a Primatene Mist user, the FDA recommends that you see a health care professional soon to get another medicine. A doctor, physician assistant, or nurse practitioner can all help you determine the best treatment option for you. Primatene Mist may be harder to find on store shelves even before Dec. 31, 2011.

From the FDA: Primatene Mist With Chlorofluorocarbons No Longer Available After Dec. 31, 2011

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Securing Pharma Supply Chain - Senate HELP Committee Hearing - Videos

The Senate Health, Education, Labor and Pensions (HELP) Committee is examining the globalization of the pharmaceutical drug market and supply chain. Senators are seeking solutions for how to improve the FDA's inspection of foreign drugmakers and secure the drug supply chain - without adding too much to the agency's bottom line.

Here's a brief video snippet of the entire hearing. Senator Mike Enzi (R-Wyo.), Ranking Member on the Senate Health, Education, Labor and Pensions (HELP) Committee:

You can watch the entire hearing, Senate Committee on Health, Education, Labor and Pensions - Full Committee Hearing - Securing the Pharmaceutical Supply Chain - September 14, 2011 (video).  If you follow this link, you can access the text of the testimony given by each witness.  If you want a slightly larger video image, you can try watching:  C-SPAN - Committee Examines Foreign-made Pharmaceuticals - September 14, 2011 (video). 

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Make GMP Training Effective - free tips

Allan Dewes
President - SkillsPlus Intl Inc.

More food for your GMP training thoughts. Some free training tips.

Why GMP Training Does Seem To Work - SkillsPlus International Inc. Training Tips (pdf):  'via Blog this'

In a nutshell:

• You must address poorly designed or delivered training.
• It is essential that you align what's preached with what's practiced.
• The organization must support and encourage GMP compliance in everything that they do.

For more information:

SkillsPlus International Inc. - Compliance training experts. GMP, QSR, Designated Representative and Exemptees.

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Will the FDA issue 10,000+ 483s in 2011?

FDA will issue 10,000+ 483s in 2011 – one every 52 minutes FDAzilla Blog:   'via Blog this'

The number is kind of shocking!  According to the FDAzilla Blog:

"Based on new data obtained by FDAzilla, the FDA should surpass 10,000 483s in 2011 for the second time in its history, breaking its all-time record for the third consecutive year."

According to e-How - The Definition of FDA 483:

FDA Form 483, is the form on which inspectors for the Food and Drug Administration detail unsatisfactory results of their inspection of manufacturing facilities for compliance with current good manufacturing practices (cGMP). The FDA inspects plants making human drugs (both prescription and over-the-counter drugs), animal and veterinary drugs, medical devices, food, radiation-emitting products, vaccines, blood and biological products and cosmetics for compliance with cGMP.

You might also be interested in:

Inspection Detection - a GMP training game by SkillsPlus Intl Inc.

An extensive library of 483 citation summaries from the FDA. Match the case with the corresponding 21 CFR 211 reference. Used as a classroom training tool or for self-study, this training aid challenges the student to identify and justify the 21 CFR 211 reference that supports the 483 citation.

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Raise Mesothelioma Awareness - Mon 9-26

Image via WikipediaHelp raise awareness of mesothelioma and curemeso.org with an appearance in the Today Show's audience!,

Mesothelioma Applied Research Foundation:   'via Blog this'

Wendi Lewis reports in Meso warriors will assemble on the Plaza for Mesothelioma Awareness Day:

"The Mesothelioma Applied Research Foundation is once again issuing the call for all Meso Warriors to gather at Rockefeller Plaza in New York City on Monday, September 26, for Mesothelioma Awareness Day."

• Festivities will kick off on Sunday, Sept. 25, at 6 p.m. with a gathering at Bill’s Bar and Burger Rockefeller Center. 
• Monday, Sept. 26, Meso Warriors will meet on Rockefeller Plaza at 5:30 a.m. ET.

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GMP Audit Checklist For Drug Manufacturers

GMP Audit Checklist For Drug Manufacturers:  'via Blog this'

I'm always on the lookout for goodies out there.  Checkout this audit checklist.

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FDA on Tattoos and Permanent Makeup

FDA Webinar on Tattoos and Permanent Makeup:  'via Blog this'

The FDA hosted a webinar on tattoos and permanent makeup. Bhakti Petigara Harp, Ph.D., of the Office of Cosmetics and Colors, Division of Color Certification and Technology in FDA's Center for Food Safety and Applied Nutrition, provided an overview of the composition of tattoo and permanent makeup inks and the pigments used in them, as well as their regulatory status. Dr. Petigara Harp talked about problems that have occurred with the use of these inks, such as allergic reactions, infections, and scarring, and addressed FDA's response to these occurrences. She also discussed misrepresentation of these inks and pigments as "FDA approved." FDA on Tattoos and Permanent Makeup (webinar slides - pdf) 

Background:
FDA considers the inks used in intradermal tattoos, including permanent makeup, to be cosmetics and considers the pigments used in the inks to be color additives requiring premarket approval under the Federal Food, Drug, and Cosmetic Act. However, because of other public health priorities and a previous lack of evidence of safety concerns, FDA traditionally has not exercised its regulatory authority over tattoo inks or the pigments used in them. The actual practice of tattooing is regulated by local jurisdictions. In addition, concerns raised by the scientific community regarding the pigments used in these inks have prompted FDA to investigate the safe use of tattoo inks. FDA continues to evaluate the extent and severity of adverse events associated with tattooing and is conducting research on inks. As new information is assessed, the agency will consider whether additional actions are necessary to protect public health.
Image via Wikipedia

Additional Resources:
FDA Resources - Tattoos and Permanent Makeup - Resources on tattoos, permanent makeup, temporary tattoos, and henna (mehndi).

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Sixth Annual FDA Inspections Summit

Sixth Annual FDA Inspections Summit:  'via Blog this'

This caught my eye. I'm sharing it because I know that many of you have an interest in FDA inspections.  The Sixth Annual FDA Inspections Summit is scheduled for Tuesday, Oct. 4 - Thursday, Oct. 6, 2011, in Bethesda, MD.

With a quick Google search, the other large event seminar offering an FDA Inspection focus, was this seminar held earlier in the year:

ISPE - The FDA inspection enforcement trends seminar, titled, “Pharmaceutical Inspections and Compliance: Current FDA Enforcement Trends,”

You might also be interested in:
Inspection Detection - a training program that can be used as a classroom training tool or for self study

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Drug Poisoning Increase In Children

Pharmaceutical drug poisonings rise in children - latimes.com:  'via Blog this'

The LA Times article gives a nice highlight and summary of the much longer research article published in the Journal of Pediatrics, The Growing Impact of Pediatric Pharmaceutical Poisoning.

To give you an idea of what they found,  I'm sharing just a portion of their conclusion:

"We conclude that the problem of pediatric medication poisoning is getting worse, not better. Past preventive efforts have proved to be inadequate. More children are exposed, more are seen in an ED, more are admitted, and more are injured each year."

Not surprisingly, there are mentions that medical bottles and packages may need to be redesigned to limit how fast a child can consume medication, and that drugs should be stored in locked cabinets, and unused medications need to removed from the home.

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Women - A Drink A Day Leads to Longer Life

Image via WikipediaStudy of the Day: One Drink a Day May Lead to One Long Life - Atlantic Mobile:  'via Blog this'

"Talk about toast-worthy. New research shows, for older women, one alcoholic beverage a day may help keep the doctor away."

Reference:
The full study, "Alcohol Consumption at Midlife and Successful Ageing in Women: A Prospective Cohort Analysis in the Nurses' Health Study," is published in the journal PLoS Medicine.

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The FDA on Gluten-Free Food Labeling

FDA Consumer Updates; A Glimpse at 'Gluten-Free' Food Labeling:  'via Blog this'

Whether as muffins, rolls, or loaves, wheat bread is found in most households. But few consumers may appreciate the substance that helps the dough rise, keeps the bread from falling apart, makes it chewy, and adds to its flavor.

That substance is gluten. Breads, cakes, cereals, pastas, and many other foods are made with wheat or added wheat gluten to improve their baking quality and texture.

Technically, gluten represents specific proteins that occur naturally in wheat. However, the term “gluten” is commonly used to refer to certain proteins that occur naturally not only in wheat, but also in rye, barley, and crossbreeds of these grains and that can harm people who have celiac disease. The only treatment for this disorder is a life-long gluten-free diet.


FDA Press Announcements; FDA reopens comment period on proposed ‘gluten-free’ food labeling rule:

The U.S. Food and Drug Administration today reopened the comment period for its 2007 proposal on labeling foods as “gluten-free.” The agency is also making available a safety assessment of exposure to gluten for people with celiac disease (CD) and invites comment on these additional data.

One of the criteria proposed is that foods bearing the claim cannot contain 20 parts per million (ppm) or more gluten. The agency based the proposal, in part, on the available methods for gluten detection. The validated methods could not reliably detect the amount of gluten in a food when the level was less than 20 ppm. The threshold of less than 20 ppm also is similar to “gluten-free” labeling standards used by many other countries.

“Before finalizing our gluten-free definition, we want up-to-date input from affected consumers, the food industry, and others to help assure that the label strikes the right balance,” said Michael Taylor, deputy commissioner for foods. “We must take into account the need to protect individuals with celiac disease from adverse health consequences while ensuring that food manufacturers can meet the needs of consumers by producing a wide variety of gluten-free foods.”

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Offshore Drug Manufacturing Plants - Quality problems more likely

Image via WikipediaQuality problems more likely in offshore drug plants, study finds - FiercePharma:  'via Blog this'

"Researchers found drugs made in offshore plants are more likely to have quality problems than meds made by the same companies in the U.S. -- and that calls into question the industry's move to ship more production overseas."

According to one of the authors, John Gray, in the release from Ohio State:

"One of the managers I spoke to currently in a Puerto Rican plant said it best: No one here knows what it looks like to run a world-class operation in terms of quality control. This kind of knowledge can't just come from books and manuals, especially when you're dealing with workers who speak another language and come from another culture."

For more information:
Quality risk in offshore manufacturing: Evidence from the pharmaceutical industry (abstract)

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Disaster Supplies and Preparedness Checklist

Image via WikipediaThere have been recent global earthquakes, floods, and storms.

I live in the San Francisco Bay Area of California, and I sense that we're due for an earthquake.

To that end, I'm sharing this checklist for all of us to start following, so that we can be fully prepared for whatever disaster comes our way:

Your Family Disaster Supplies and Preparedness Calendar (pdf)

Be safe, be well!

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21 CFR 11 Questions and Answers

Compliance Zen: Recent 21 CFR 11 Questions and Answers:  'via Blog this'

A nice collection of things you should know about 21 CFR 11 by John Avellanet.

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CDRH Learn Course List (Spanish)

CDRH Learn; CDRH Learn Course List (Spanish):   'via Blog this'

It's great to see the FDA continue to expand their free training offerings, especially these in Spanish

CDRH Learn Course List (Spanish)
Listed below are the courses CDRH currently offers in Spanish. Additional online courses are being developed.

Course List

1. Overview of Regulatory Requirements: Medical Devices [New! 9/2]
2. Quality System Regulation 21 CFR Part 820 Basic Introduction
3. Export Certificates for Medical Devices
4. Overview of the Premarket Notification Process - 510(k)
5. Bioresearch Monitoring (BIMO) [New! 7/25]
6. Medical Device Reporting

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Medical device software criticized as under-regulated - latimes.com

Image via WikipediaMedical device software criticized as under-regulated - latimes.com:  'via Blog this'

In a nutshell:

"Between 1983 and 1997, 1 in 4 medical devices used software. Today, the figure is more than half. Software problems are now the third-leading cause for recalls of medical devices."

Just when you thought technology might move us ahead.

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Standing Desks Are on the rise

Standing Desks Are on the Rise - WSJ.com:  'via Blog this'

For the longest time, I always wondered why some folks had these kind of desks in my office.

Now I know!  Standing desks for good health.

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Emergency Situations (Medical Devices): Free FDA Preparedness Tips

Emergency Situations (Medical Devices); FDA Offers Tips about Medical Devices and Hurricane Disasters:  'via Blog this'

With the recent string of storm, hurricanes, and earthquakes, it might be worthwhile to review these free FDA disaster preparedness tips.

The tips focus on medical devices, and there are many more important and related tips to consider.

Be safe, be well.

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FDA - 21 CFR 820 - Formatted for Mobile

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