Supplement-Maker Who Diluted Products With Other Powders Sentenced To 40 Months In Prison – Consumerist

Read the full article: Supplement-Maker Who Diluted Products With Other Powders Sentenced To 40 Months In Prison – Consumerist:

"When you buy a food product or a dietary supplement, you should be confident that the product’s ingredients are listed on the label, and that you’re getting what you paid for. Federal prosecutors say that one dietary supplement wholesaler in New Jersey spent four years selling products diluted with products like maltodextrin or rice flour, increasing profits but defrauding customers. The company’s owner now must forfeit $1 million in profits and has been sentenced to 40 months in prison and one year of supervised release."

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Need a Guidance Document? We’ve Got You Covered | FDA Voice

• FDA GMP Online Training - people speak highly of CGMP online training courses offered by SkillsPlus International Inc. (a regulatory compliance training provider)

Updated February 21, 2021

Links broke in the original post.

People also ask how to search for FDA guidance documents:

Search for FDA Guidance Documents - FDA.gov

- - -  the original post follows below  - - -

Read the complete post:  Need a Guidance Document? We’ve Got You Covered | FDA Voice:

"FDA’s Web & Digital Media team and the Office of Information Management and Technology have created a dynamic search list on one site so you can go to just one page and find the guidance documents you need, no matter where they are on FDA.gov. This search tool is powerful and easy to use. Now you can go to just one search box to find what you need in moments, instead of the 10 different pages on FDA’s website where guidance documents are posted."

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The FDA Guidance Search Tool: Search for FDA Guidance Documents

#FDA #GMP #training #cGMP

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The F.D.A.’s Medical Device Problem - The New York Times

Read the full op-ed: The F.D.A.’s Medical Device Problem - The New York Times:

"The 21st Century Cures Act would subject millions of Americans to unsafe or untested medical devices. We urge the Senate, as it takes up the bill, to avoid these dangerous provisions. Unlike medical drugs, which can readily be discontinued if problems are found, many medical devices are permanently implanted and cannot easily be removed if found to be defective. Stricter evidence standards and increased federal funding of the F.D.A. are needed to ensure that innovative medical devices lead to better health."

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#FDA #GMP #training #cGMP

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Your Google Searches Could Help the FDA Find Drug Side Effects - Bloomberg Business

Read the full article: Your Google Searches Could Help the FDA Find Drug Side Effects - Bloomberg Business:

"FDA spokesman Chris Kelly called the meeting an introduction and a chance "for the agency to begin a discussion on how we might collaborate with Google on identifying adverse event data, using Google’s technologies and data.”"

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SurgeonRatings.org website makes data on surgeon performance public - CBS News

Read the full news article: SurgeonRatings.org website makes data on surgeon performance public - CBS News:

"A non-profit group is making millions of records on surgeon performance available to the public.

The consumer advocacy group Consumers' Checkbook launched the website SurgeonRatings.org, which provides open access to detailed government records on patient outcomes after surgery. It says the site was created after a ten-year campaign to convince the government to release Medicare records to the public."

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FDA Issues Final Rule on Permanent Discontinuance or Interruption in Manufacturing of Certain Drug or Biological Products - FDA Law Blog

Read the full article: FDA Law Blog: FDA Issues Final Rule on Permanent Discontinuance or Interruption in Manufacturing of Certain Drug or Biological Products:

"The final rule requires “all applicants of covered approved drugs or biological products—including certain applicants of blood or blood components for transfusion and all manufacturers of covered drugs marketed without an approved application—to notify FDA electronically of permanent discontinuance or an interruption in manufacturing of the product that is likely to lead to a meaningful disruption in supply (or a significant disruption in supply for blood or blood components) of the products in the United States.”"

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Federal Register | Permanent Discontinuance or Interruption in Manufacturing of Certain Drug or Biological Products

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FDA Strengthens Warning of Heart Attack and Stroke Risk for Non-Steroidal Anti-Inflammatory Drugs - Consumer Updates

Read the full update: FDA Consumer Updates > FDA Strengthens Warning of Heart Attack and Stroke Risk for Non-Steroidal Anti-Inflammatory Drugs:

"FDA is strengthening an existing warning in prescription drug labels and over-the-counter (OTC) Drug Facts labels to indicate that nonsteroidal anti-inflammatory drugs (NSAIDs) can increase the chance of a heart attack or stroke, either of which can lead to death. Those serious side effects can occur as early as the first few weeks of using an NSAID, and the risk might rise the longer people take NSAIDs. (Although aspirin is also an NSAID, this revised warning doesn’t apply to aspirin.)"

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Who Offers GMP Training?

Who Offers GMP Training?

SkillsPlus International Inc. offers highly respected cGMP training. 

SkillsPlus Intl Inc. can be your one-stop shop that:

• meets your needs, 
• wows students, and 
• makes your training delivery easier!

Visit SkillsPlus Intl Inc. training products & services, or call  (415) 948-5220.

#FDA #GMP #training #cGMP #courses #classes

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Gov. Jerry Brown signs bill to impose strict school vaccine legislation in California | abc7.com

Read the full article: Gov. Jerry Brown signs bill to impose strict school vaccine legislation in California | abc7.com:

"The governor of California has signed a contentious bill to impose one of the strictest school vaccination laws in the country.

Democratic Gov. Jerry Brown says in a statement Tuesday that science clearly shows vaccines dramatically protect children against infectious diseases."

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Scientists describe the gross reason why your eyes sometimes sting, turn red in swimming pools - The Washington Post

Read the full article: Scientists describe the gross reason why your eyes sometimes sting, turn red in swimming pools - The Washington Post:

"The CDC also said in its report that the chlorine smell of pools isn't actually what you think. "What you smell are actually chemicals that form when chlorine mixes with pee, poop, sweat and dirt from swimmer's bodies... These chemicals -- not chlorine -- can cause your eyes to get red and sting, make your nose run, and make you cough."

"Yuck!" the CDC concluded."

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#FDA #GMP #training #cGMP

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Fidgeting May Benefit Children With A.D.H.D. - The New York Times

Read the full article: Fidgeting May Benefit Children With A.D.H.D. - The New York Times:

"“I know it’s difficult to accommodate hyperactivity,” Dr. Schweitzer said, but it may really help children whose fidgeting bodies seem to contribute to calmer, more focused brains."

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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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Q7 Q&As - Quality Guidelines : ICH

• Respected FDA cGMP online training courses and programs taught by SkillsPlus International Inc.

Q7 Q&As - Questions and Answers: Good Manufacturing Practice Guide for Active Pharmaceutical Ingredients

Follow this link to the Q7 section: Q7 Q&As - Quality Guidelines : ICH:

"Experience gained with the implementation of the ICH Q7 Guideline since its finalisation in 2000 shows that uncertainties related to the interpretation of some sections exist. Technical issues with regard to GMP of APIs – also in context with new ICH Guidelines - are addressed in this Question and Answer document in order to harmonise expectations during inspections, to remove ambiguities and uncertainties and also to harmonise the inspections of both small molecules and biotech APIs."

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The FDA takes step to remove artificial trans fats in processed foods

Read the full release:  Press Announcements > The FDA takes step to remove artificial trans fats in processed foods - FDA.gov:

"Based on a thorough review of the scientific evidence, the U.S. Food and Drug Administration today finalized its determination that partially hydrogenated oils (PHOs), the primary dietary source of artificial trans fat in processed foods, are not “generally recognized as safe” or GRAS for use in human food. Food manufacturers will have three years to remove PHOs from products. "

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Sleeping Pill Use Raises Car Crash Risk, Study Finds - NBC News

Read the full article: Sleeping Pill Use Raises Car Crash Risk, Study Finds - NBC News:

"Sleeping pills such as Ambien and Restoril may double someone's risk of a car crash — even after their effects should have worn off — and may raise the risk as much as having too much to drink, researchers reported Thursday.

A close look at medical and driving records showed that people who took any one of the three popular sleeping aids had anywhere between a 25 percent and three times higher risk of being involved in an accident while driving."

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Rising Cyber Attacks Costing Health System $6 Billion Annually - Bloomberg Business

Read the full article: Rising Cyber Attacks Costing Health System $6 Billion Annually - Bloomberg Business:

"Criminal attacks against health-care providers have more than doubled in the past five years, with the average data breach costing a hospital $2.1 million, according to a study today from the Ponemon Institute, a security research and consulting firm. Nearly 90 percent of health-care providers were hit by breaches in the past two years, half of them criminal in nature, the report found."

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Root Cause Analysis for Better Deviation Investigations - GMP Training

Root Cause Analysis for Better Deviation Investigations - A cGMP Training Course

A top reason why companies receive a 483 is a deficiency in the deviation investigation process. In our experience, most employees need deviation investigation training, and here's why:

• Staff struggle to solve problems
• Teams often fail to get results
• The pharma and biotech sector repeatedly demonstrate difficulty in complying with FDA expectations for thorough deviation investigations.

In this SkillsPlus International Inc. hands-on workshop, employees learn the most effective tools to determine the real root cause of the problem. Attendees use actual plant deviations to practice the use of the tools. Allan Dewes, the lead instructor, has taught this course all over the world with exceptional results.

Call (415) 948-5220, or learn more: http://www.skillsplusinc.com/root_cause.htm

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Why Your Future Vaccination Might Not Be A Shot : NPR

Read the full article: Why Your Future Vaccination Might Not Be A Shot : Goats and Soda : NPR:

"Vaccines don't always make it into the people who need them the most. Many require a syringe and a needle to enter the bloodstream and create immunity. And that means a doctor or nurse has to do the job.

But with if a vaccine could be delivered by simply applying a patch? That's Mark Prausnitz's goal: creating a nickel-sized bandage-like device covered with 100 microscopic needles that would puncture the skin, then dissolve to get the vaccine into the body."

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FDA seeks more data on safety of hospital hand cleaners - Yahoo News

• Respected FDA GMP online training courses and programs taught by SkillsPlus International Inc.

Updated October 6, 2021

The original link broke.

You can still read about the same topic here:

FDA seeks more data on safety of hospital hand cleaners - Medical Xpress

Safely Using Hand Sanitizer - FDA.gov

---  the original post follows below  ---

Read the full article: FDA seeks more data on safety of hospital hand cleaners - Yahoo News:

"Federal health officials say more information is needed to establish the safety and effectiveness of common hand cleaners used in hospitals, doctors' offices and nursing homes to kill germs and prevent infections.

The Food and Drug Administration is asking manufacturers to submit additional data about medical hand washes and sanitizers, including the long-term effects of their daily use on the skin."

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World Health Day 2015: A Global Focus on Food Safety | FDA Voice

Updated February 9, 2022

The original link broke.

You can still read about the same topic here:

World Health Day 2015: Food Safety - WHO

---  the original post follows below  ---

Read the full post:  World Health Day 2015: A Global Focus on Food Safety | FDA Voice:

"Food safety is a public health issue that affects all nations – from the most advanced to the most poor. World Health Day, observed on April 7 each year to mark the anniversary of the 1948 founding of the World Health Organization (WHO), gives us an opportunity to reflect on the progress that has been made to address the need for strong food safety systems, and on the enormous challenges that lie ahead.

The global importance of this issue is reflected in this year’s World Health Day theme: “Food Safety: From Farm to Plate, Keep it Safe.”  Keeping food safe, from farm to table, is at the core of our mission as an agency and at the heart of the preventive, risk-focused food safety system envisioned by the FDA Food Safety Modernization Act (FSMA)."

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