Halloween Safety Tips: Costumes, Candy, and Colored Contact Lenses

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Halloween Safety Tips: Costumes, Candy, and Colored Contact Lenses - FDA.gov

According to the FDA: 

"Enjoy a safe and happy Halloween by following these guidelines.

Halloween is fast approaching, and you and your kids may be celebrating it a bit differently this year. Whatever form your celebration takes, make sure it includes safe hygiene practices such as covering your mouth and nose with a cloth face covering or mask when around others, maintaining social distance and frequent hand washing.  The Centers for Disease Control also have tips for protecting yourself and others.

Whether you’re a ghost or zombie, vampire or witch, poor costume choices—including decorative (colored) contact lenses and flammable costumes—and face paint allergies can cause injuries that haunt you long after Halloween.

Enjoy a safe and happy Halloween by following these guidelines from FDA, the Consumer Product Safety Commission, and the Centers for Disease Control and Prevention:" ...

Shop Around for Lower Drug Prices - Consumer Reports

Read the full article:   Shop Around for Lower Drug Prices - Consumer Reports

". . . we found that the lowest retail prices in pharmacies can sometimes be a better deal than using insurance, especially in the case of drugs that aren’t covered well"

This is a good article, with several helpful tips on how to save money, by shopping for the best
prescription prices.

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Pediatricians Release New Guidance For Preventing Sudden Infant Deaths : The Two-Way : NPR

Read the full article: Pediatricians Release New Guidance For Preventing Sudden Infant Deaths : The Two-Way : NPR:

"The pediatricians say that children should sleep in the same room but on a separate surface from their parents for at least the first six months of their lives, and ideally the first year. They say that this can halve the risk of SIDS."

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cGMP basics training for newbies and seasoned staff

#FDA #GMP #cGMP #training #course #class

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How to save on prescription drugs - marinij.com

Follow this link to some great suggestions:  How to save on prescription drugs - marinij.com:

"For more ways to save money on your next prescription, remember:" . . .

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In-Person Ways to Avoid Form 483 Observations and Warning Letters | MDDI - Free Tips

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Read the full article for free tips: In-Person Ways to Avoid Form 483 Observations and Warning Letters | MDDI Medical Device and Diagnostic Industry News Products and Suppliers:

"For many medical device companies, it's a scary idea that an FDA inspector could show up at your reception desk tomorrow—or even today. Device executives need to ensure that everyone, from their regulatory affairs team to their receptionist, know how to interact with FDA personnel."

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#free #tips

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Inspection Observations - FDA.gov

Go to this FDA webpage:  Inspections > Inspection Observations - FDA.gov:

"FDA’s Office of Regulatory Affairs (ORA) is the lead office for all field activities, including inspections and enforcement. During an inspection, ORA investigators may observe conditions they deem to be objectionable. These observations, are listed on an FDA Form 483 when, in an investigator’s judgment, the observed conditions or practices indicate that an FDA-regulated product may be in violation of FDA’s requirements.

Spreadsheets summarizing the areas of regulation cited on FDA's system-generated 483s are available by fiscal year on the menu links on this page. These spreadsheets are not a comprehensive listing of all inspectional observations but represent the area of regulation and the number of times it was cited as an observation on an FDA Form 483 during inspections conducted by FDA and its representatives. Turbo EIR is FDA's automated Form 483 reporting system. Turbo EIR is utilized to generate the FDA Form 483 when applicable cite modules exist. Not all FDA Form 483s are generated in TurboEIR as some 483s are manually prepared and not available in this format. Observations have been broken out by Product or Program Area on separate tabs of the spreadsheet. The Product and Program Areas include the following:

• Biologics
• Drugs
• Devices
• Human Tissue for Transplantation
• Radiological Health
• Parts 1240 and 1250"

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In fiscal year 2014, you'll notice that biologics and drugs areas were highly associated with some kind of sub-standard investigation.

You might also be interested in this workshop:

Root Cause Analysis for Better Investigations - a cGMP Training Workshop by SkillsPlus Intl Inc.

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Next Time an FDA Inspector Visits, Make Sure Everything is Dusted - Pharmalot - WSJ

Read the full article: Next Time an FDA Inspector Visits, Make Sure Everything is Dusted - Pharmalot - WSJ:

"Records indicated the company supposedly used an oxygen analyzer to obtain test results. But the FDA inspector displayed a Sherlock Holmesian propensity for uncovering discrepancies. The inspector spotted cobwebs running from the portable oxygen analyzer to an adjacent wall, according to the letter. In other words, the analyzer had not been used for, well, a while."

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FDA > Buy, Store & Serve Safe Food > Safe Food Handling: What You Need to Know

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Read the full article: Buy, Store & Serve Safe Food > Safe Food Handling: What You Need to Know - FDA.gov:

"The Federal government estimates that there are about 48 million cases of foodborne illness annually – the equivalent of sickening 1 in 6 Americans each year. And each year these illnesses result in an estimated 128,000 hospitalizations and 3,000 deaths.

Since foodborne illness can be serious — or even fatal — it is important for you to know and practice safe food handling behaviors to help reduce your risk of accidentally getting sick from contaminated food."

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CRN FDA GMP Warning Letter Database - For Dietary Supplements - Free

Read the full press release: CRN FDA GMP Warning Letter Database Document:

"The Council for Responsible Nutrition (CRN), the leading trade association for the dietary supplement and functional food industry, today announced a free online tool that compiles FDA Warning Letters sent to dietary supplement companies into a searchable database to help industry achieve better regulatory compliance. The database can be used to evaluate FDA’s warning letter allegations of good manufacturing practices (GMPs) violations, products making impermissible claims, and products tainted with illegal ingredients."

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Access the CRN FDA Warning Letters Database for Dietary Supplements

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FDA - Consumer Updates > Food Safety Tips for Healthy Holidays

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Read the full article: Consumer Updates > Food Safety Tips for Healthy Holidays - FDA.gov:

"Combating bacteria, viruses, parasites, and other contaminants in our food supply is a high priority for the Food and Drug Administration. But consumers have a role to play, too, especially when it comes to safe food-handling practices in the home.

"The good news is that practicing four basic food safety measures can help prevent foodborne illness," says Marjorie Davidson, a consumer educator at FDA."

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Best Practices for Handling FDA Inspections - Pharmaceutical Compliance Monitor

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Updated July 30, 2021

Sadly, the original link broke.

---  the original post follows below  ---

Read the full article: Best Practices for Handling FDA Inspections - Pharmaceutical Compliance Monitor:

"Successfully managing an FDA inspection begins with the development of a clear company policy. It requires frequent employee training so they are in a position to maintain best practices regarding day-to-day procedures. Companies also need to make sure they define the roles and responsibilities of all company employees during an inspection.

Based on 15 years of experience and eight successful FDA inspections, here are some best practices to prepare for a successful FDA Inspection."

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Eating Outdoors, Handling Food Safely - from the FDA

Consumers > Eating Outdoors, Handling Food Safely - FDA:

"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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More from the FDA:

• 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: For Women > Dietary Supplements: Tips for Women

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For Women > Dietary Supplements: Tips for Women - FDA:

"Dietary supplements are products that people add to their diets. They include vitamins, minerals, herbs, and amino acids. They can be pills, liquids, powders or energy bars.

Although dietary supplements can help support good health, they may also cause side effects and health problems. It is important to think about the health benefits and risks before taking any product.

Tips for Women
Anyone can have problems with dietary supplements. Some women need to take special steps to stay safe."

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FDA Finalizes 2009 Draft Guidance on Distinguishing Liquid Dietary Supplements from Beverages - FDA Law Blog

FDA Law Blog: FDA Finalizes 2009 Draft Guidance on Distinguishing Liquid Dietary Supplements from Beverages:

"Compared to the 2009 draft guidance, the final guidance “Distinguishing Liquid Dietary Supplements from Beverages” provides considerably more information, including specific examples, on the factors FDA considers when determining whether the product is a conventional food or a dietary supplement.  As mentioned in the draft guidance, FDA considers labeling and advertising, product name, product packaging, serving size and recommended daily intake, directions for use, marketing practices and composition.  Where the draft guidance merely listed these factors, the final guidance discusses each factor and provides specific examples."

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The two new guidances:
Distinguishing Liquid Dietary Supplements from Beverages (PDF)
Considerations Regarding Substances Added to Foods, Including Beverages and Dietary Supplement (PDF)

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Emergency Situations (Medical Devices) > FDA Offers Tips about Medical Devices

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Emergency Situations (Medical Devices) > FDA Offers Tips about Medical Devices and Hurricane Disasters:

"Warning about Potential Carbon Monoxide Problems when Using Generators

Since many medical devices used in the home require a source of electrical power, generators are often used to supply electricity during a general power outage. The following points should be followed to prevent carbon monoxide poisoning." . . .

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Buy, Store & Serve Safe Food - The FDA on Holiday Food Safety

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Buy, Store & Serve Safe Food > Holiday Food Safety - FDA.gov:

"Many people don't realize that food safety is the most important ingredient in preparing food for the holidays. Below are some helpful food safety resources to keep your holidays happy.

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10 Tips to Avoid Holiday Weight Gain - HealthCastle

Updated November 14, 2021

The original link broke.

You can still read about the same topic here:

20 Tips to Avoid Weight Gain During the Holidays - Healthline

---  the original link follows below  ---

Follow the link below to view the 10 tips . . .

10 Tips to Avoid Holiday Weight Gain - HealthCastle:

"The holiday and party season is upon us! Studies show that the weight gain around this time of year is more than just an urban legend. It adds up to a solid 1-2 pounds per year for most adults, more for adults who are already overweight. This year, skip the weight gain altogether and stay one step closer to your best self with these easy strategies."

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Mobile Medical Applications: Guidance Finalized - FDA Law Blog

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FDA Law Blog: Mobile Medical Applications: A Thoughtful Guidance Is Finalized:

"The final guidance is similar to the draft guidance – but with improved clarity. Hence, it has expanded from 29 to 43 pages. Most of the additional pages are appendices with examples and other supplementary information. This guidance is sensible and well written."

Follow this link to the Mobile Medical Applications - FDA Guidance for Industry and Food and Drug Administration Staff (PDF)

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New Joint Commission Video Offers Advice on Medical Care at Home

New Joint Commission Video Offers Advice on Medical Care at Home:

"Video characters Nurse Clare, Home Care Aide Jesse and Home Medical Equipment Specialist Boyd help Hector in his home with his IV, oxygen tank and daily living needs while his wife Reyna watches and helps. "Speak Up: At Home" emphasizes that patients and their families or friends should ask questions in order to be sure they receive the care necessary to get better."

Follow this link to the video, Speak Up: At Home

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MedlinePlus - Free Health Information from the NLM

This is a great collection of health-related information, resources, tools, and more! It's FREE!

MedlinePlus - Health Information from the National Library of Medicine

"MedlinePlus is the National Institutes of Health's Web site for patients and their families and friends. Produced by the National Library of Medicine, it brings you information about diseases, conditions, and wellness issues in language you can understand. MedlinePlus offers reliable, up-to-date health information, anytime, anywhere, for free."

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