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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You might also be interested in:

• Pack and Transport Food Safely
• Quick Tips for Picnic Site Prep
• Follow Safe Grilling Tips
• Serving Picnic Food: Keep it Cold/Hot

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FDA approves 1st exoskeleton to help paralyzed walk again | MassDevice

Read the full article (and view video): FDA approves 1st exoskeleton to help paralyzed walk again | MassDevice:

"FDA regulators announced this evening that they approved for the U.S. market the 1st robotic exo-suit for helping patients with lower-body paralysis walk upright.

Called ReWalk , the motorized system is comprised of metal leg braces that strap around the legs and back, supplying movement to joints in the hips, knees and ankles. The system includes a watch-based remote that controls the suit's movements and patients rely on crutches to provide stability."

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Aspirin May Cut Pancreatic Cancer Risk - NYTimes.com

Read the full article: Aspirin May Cut Pancreatic Cancer Risk - NYTimes.com:

"A new study adds to the evidence that low-dose aspirin, known to reduce the risk for heart disease, may also reduce the risk for pancreatic cancer.

Pancreatic cancer has a 93 percent fatality rate, and the National Cancer Institute estimates there will be about 46,000 new cases and 40,000 deaths from the disease this year."

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Dietary Supplement Manufacturer Audit Preparation - NPI

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Read the full article: Dietary Supplement Manufacturer Audit Preparation - NPI:

"Common Mistakes Auditors Find

Recent GMP audits reveal companies failure to perform tasks in two main areas:

Quality Issues

• Perform required identity testing on incoming dietary ingredients raw materials
• Set appropriate specifications for raw materials, components and finished good product
• Perform finished good product testing confirming identity, strength and composition
• Lack of finished product release criteria (does finished batch conform to product spec?)
• Adopt written procedures (e.g., SOPs)
• Prepare and follow master manufacturing records (MMR) and/or batch production records (BPRs) for manufacture of dietary supplements (with formulation and batch size)
• Document corrective actions undertaken
• To conduct required material reviews and make disposition decisions

Facility Issues

• Physical plant design
• Sanitation requirements of the physical plant and associated grounds
• Issues with manufacturing equipment and utensils"

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Electrical Current To Heal Cavities - Business Insider

Updated Dec 8, 2015:
You might also be interested in:
Goodbye to dental fillings? ‘No-drill’ techniques can treat tooth decay just as well, study finds

= = =  original post follows below  = = =

Read the full article: Electrical Current To Heal Cavities - Business Insider:

"Researchers at King's College London have developed a technique called Electrically Accelerated and Enhanced Remineralzation, in which a device they've dubbed a "healing hand piece" is placed over the site of a cavity. The tool emits a small electrical current that promotes the remineralization of the tooth, driving calcium, phosphate, and other substances back into the enamel, the scientists told the Washington Post (cavities happen when bacteria break down, or demineralize, the enamel with acid). The technique would take about as much time and cost about the same or less than a traditional filling, and publications describing the technique should be published "in coming months," they said."

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Marijuana Considered for Looser Restrictions by U.S. FDA - Bloomberg

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Read the full article: Marijuana Considered for Looser Restrictions by U.S. FDA - Bloomberg:

"U.S. regulators are studying whether restrictions on marijuana should be eased, a step toward decriminalizing the drug at the federal level.

The Food and Drug Administration is conducting an analysis at the Drug Enforcement Administration’s request on whether the U.S. should downgrade the classification of marijuana as a Schedule 1 drug, said Douglas Throckmorton, Deputy Director for Regulatory Programs at the FDA, at a congressional hearing."

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Medtronic got hacked, company reveals | MassDevice

Read the full article: Medtronic got hacked, company reveals | MassDevice:

"Medtronic reported in regulatory filings today that it and 2 other unnamed "large medical device manufacturers" were targeted by hackers appearing to originate from Asia. Those infiltrators didn't breach any patient data, Medtronic assured regulators.

Medtronic offered few other details regarding the hack, but the disclosure seems to fall in line with an reports earlier this year that Chinese hackers targeted systems at Medtronic, Boston Scientific (NYSE:BSX) and St. Jude Medical (NYSE:STJ)."

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Put Medicines Up and Away For Child Safety

The FDA emphasizes that it's National Safety Month.

View the website of: Up and Away:

"Any kind of medicine or vitamin can cause harm if taken in the wrong way, even medicine you can buy without a prescription. Walk around your house and find a storage place too high for a child to reach or see."

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FDA > Fish: What Pregnant Women and Parents Should Know

Read the full article: Metals > Fish: What Pregnant Women and Parents Should Know - FDA:

"Key Message:  Eat 8 to 12 ounces of a variety of fish* each week from choices that are lower in mercury. The nutritional value of fish is important during growth and development before birth, in early infancy for breastfed infants, and in childhood."

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Warning - What Is Secondary Drowning of Kids?

Updated February 9, 2017 (the original video disappeared):

I've never heard of "Secondary Drowning" until now.  Now that school is out for Summer, be on the lookout.


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FDA Patient Network - What We Do

What We Do | Patient Network:

"You can use this Web site to learn more about how FDA works and how you can participate in the drug and medical device approval process."

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The Exemptee Institute
The Designated Representative Institute

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Another Free GMP Glossary

Here's another free GMP glossary.

Free cGMP Glossary by Contract Pharma - 'via Blog this'

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• Onsite cGMP Training - Olympics for Pharmaceutical & Biotech Manufacturers (skillsplusinfo.blogspot.com)

FDA issues draft guidance on nanotechnology

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Updated June 25, 2023:

The original link broke.

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GUIDANCE DOCUMENT - Drug Products, Including Biological Products, that Contain Nanomaterials - Guidance for Industry - APRIL 2022 - FDA.gov

---  the original post follows below  ---

Two draft guidance documents that address the use of nanotechnology by the food and cosmetics industries were issued today by the U.S. Food and Drug Administration.

Nanotechnology is an evolving technology that allows scientists to create, explore, and manipulate materials on a scale measured in nanometers – particles so small that they can not be seen with a regular microscope. The technology has a broad range of potential applications, such as the packaging of food or altering the look and feel of cosmetics.

Press Announcements - FDA issues draft guidance on nanotechnology:


The two draft guidance documents are: “Guidance for Industry: Assessing the Effects of Significant Manufacturing Process Changes, including Emerging Technologies, on the Safety and Regulatory Status of Food Ingredients and Food Contact Substances, Including Food Ingredients that are Color Additives” and “Guidance for Industry: Safety of Nanomaterials in Cosmetic Products.”

The food draft guidance describes the factors manufacturers should consider when determining whether changes in manufacturing processes, including those involving nanotechnology, create a significant change that may:

• affect the identity of the food substance;
• affect the safety of the use of the food substance;
• affect the regulatory status of the use of the food substance; or
• warrant a regulatory submission to FDA.

The cosmetic product draft guidance discusses the FDA’s current thinking on the safety assessment of nanomaterials when used in cosmetic products. Key points include:

• The legal requirements for cosmetics manufactured using nanomaterials are the same as those for any other cosmetics. While cosmetics are not subject to premarket approval, companies and individuals who market cosmetics are legally responsible for the safety of their products and they must be properly labeled.
• To conduct safety assessments for cosmetic products containing nanomaterials, standard safety tests may need to be modified or new methods developed.

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FDA Inspection Preparation

Don't get surprised!  Prepare yourself well in advance of an FDA inspection.

But if you should find yourself on the brink of one in a week or so, here's something helpful:
Rapid Deployment Tips to Prepare for an Inspection Quickly by John Avellanet (PDF)

If you're not so much in a rush, then invest some time in getting prepared.

You might be interested in:
Surviving an FDA Inspection - a live onsite training class

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FDA on Tattoos and Permanent Makeup

Updated November 18, 2024

The original link broke.

---  the original post follows below  ---

FDA Webinar on Tattoos and Permanent Makeup (PDF):  '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." 

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.
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Additional Resources:
Tattoos & Permanent Makeup: Fact Sheet - FDA.gov

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GMP Proper Documentation Tips - Free

Updated 10/19/2015:
The post below is outdated.  You might be interested in cGMP training by SkillsPlus Intl Inc.

===========

I found this helpful document, it's free, Documentation - Rules for Completion (GMP Trainers' Survival Kit II) - PDF

It could be especially useful for classroom trainers, or for staff trying to reinforce GMP good documentation practices.

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FDA Wants Resource Planning In Corrective Action Plans

According to the The QA Pharm blog,

"The most successful corrective action plans have been those where the direct responsible individuals are named and appear in detailed project plans. There is a clear picture of what success looks like and how to get there. But most of all, the resources are identified to execute the work."

Apparently in an FDA Warning Letter to Teva early this year,  the FDA is telegraphing their desire to see these kinds of elements in a response:

• a plan
• what kind of data will be collected to measure the effectiveness of the plan
• a timeline for the plan
• the identification of resources allocated to address the issue

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NIH Complementary and Alternative Medicine Website

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From the NIH (National Institutes of Health): 

NCCAM's (National Center for Complementary and Alternative Medicine) Time to Talk campaign encourages patients to tell their providers about CAM (complementary and alternative medicine) use and providers to ask about it by offering tools and resources — such as wallet cards, posters, and tip sheets — all of which are available for free at:   http://nccam.nih.gov/timetotalk/

More information for providers:  http://nccam.nih.gov/health/providers/.

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Sharecare.com - Expert Wellness Info

I'm a little slow getting this post out. I ran across this while reading the December issue of the AARP Bulletin. An article mentioned this website:   Sharecare ( http://www.sharecare.com/ ).

About Sharecare states:

"Our mission is to answer the world's questions of health and achieve a collective wisdom by developing a comprehensive database of all of the questions of health and wellness and actively recruiting industry experts to answer them. Leading physicians, nurses, hospitals, clinics, authors, healthcare companies and non-profits connect, interact and share their collective expertise encouraging consumers to ask, learn and act upon questions of health."

I made a quick tour of the site. It feels elegant and polished. I found it easy to navigate. At a glance it seems to offer up quickly accessible information to topics of interest.

Happy hunting!

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FDA Launches Website Explaining Food and Drug Regulations

It's a new year, and it's time to think about professional development goals for 2011.  You or your friends, family, or staff, might want to consider learning some of these FDA Basics:

FDA Basics for Industry  or
FDA Basics - Provides Information About FDA and What the Agency Does

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