Saturday, July 13, 2019

Health Fraud Scams (video) - FDA.gov

Health Fraud Scams (video) - FDA.gov



The FDA says, "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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Tuesday, July 2, 2019

COULD CANNABIS COMBAT THE OPIOID CRISIS? MARIJUANA USERS SAY DRUG HELPED THEM STOP PRESCRIPTION MEDS - Newsweek

Read the full article:  COULD CANNABIS COMBAT THE OPIOID CRISIS? MARIJUANA USERS SAY DRUG HELPED THEM STOP PRESCRIPTION MEDS - Newsweek

"Cannabis could be used instead of prescription and over-the-counter medications - including opioids - to treat pain and insomnia, researchers have found. The team also found that many people who took marijuana for pain had been able to stop taking opioids, potentially suggesting it could lower the use of these pain relievers."

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Sunday, June 16, 2019

FDA Conducts Anticipated Hearing on the Regulation of CBD Products - FrierLevitt.com

Read the full article:  FDA Conducts Anticipated Hearing on the Regulation of CBD Products - FrierLevitt.com

"At the hearing, Acting Commissioner Dr. Ned Sharpless delivered opening remarks and reiterated that recent changes to federal and state law, and the explosion of CBD products in the marketplace, have not affected FDA’s view that CBD cannot be lawfully added to any FDA-regulated consumer product. While the Agriculture Improvement Act of 2018 (the “Farm Bill”) generally legalized CBD derived from hemp (defined as cannabis with THC content below 0.3% by dry weight), the Farm Bill explicitly preserved FDA’s authority to regulate foods, drugs, dietary supplements and cosmetics containing CBD."

Still more to follow, as the entire country holds its breath on personal use and big business making huge money investments and gambles.

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FDA cGMP QSR GMP Online Training Courses by SkillsPlus International Inc.

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Friday, June 14, 2019

Statement on FDA’s scientific work to understand per- and polyfluoroalkyl substances (PFAS) in food, and findings from recent FDA surveys - FDA.gov


Read the full article:  Statement on FDA’s scientific work to understand per- and polyfluoroalkyl substances (PFAS) in food, and findings from recent FDA surveys - FDA.gov

"PFAS are a family of human-made chemicals that are found in a wide range of products used by consumers and industry. There are nearly 5,000 types of PFAS, some of which have been more widely used and studied than others. Many PFAS are impermeable to grease, water and oil. For this reason, beginning in the 1940s, PFAS have been used for many different applications including in stain- and water-resistant fabrics and carpeting, cleaning products, paints and fire-fighting foams, as well as in limited, authorized uses in cookware and food packaging and processing, referred to as food contact substances."

" ... the FDA has been working to develop new methods to quantify certain per- and polyfluoroalkyl substances (PFAS) in foods. We have employed these new methods to test samples of foods Americans typically consume for certain types of PFAS, and today we are making available recently analyzed data from these initial testing initiatives.

Overall, our findings did not detect PFAS in the vast majority of the foods tested. In addition, based on the best available current science, the FDA does not have any indication that these substances are a human health concern, in other words a food safety risk in human food, at the levels found in this limited sampling. These data give our scientists a benchmark to use as we continue our critical work studying this emerging area of science."

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FDA cGMP QSR GMP Training Courses by SkillsPlus International Inc.

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Wednesday, June 12, 2019

F.D.A. tackling C.B.D. in food - Food Business News

Read the full article:   F.D.A. tackling C.B.D. in food - Food Business News


"Stakeholders in the manufacture, distribution, use and regulation of products containing cannabis or cannabis-derived compounds, such as cannabidiol (C.B.D.), had their say before a panel of Food and Drug Administration officials during a daylong public hearing held May 31 at the agency’s White Oak Campus in Silver Spring, Md. More than 400 individuals and associations applied to address the panel; more than 100 were able to do so."

According to "Amy Abernethy, Ph.D., the F.D.A.’s deputy commissioner ... “Key questions about product safety need to be addressed. Data are needed to determine the safety thresholds for C.B.D … There are both positive supporters of cannabis and cannabis-derived products including C.B.D. and also concerned citizens worried that widely available products can be harmful.”"

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FDA cGMP QSR GMP Training Courses by SkillsPlus International Inc.

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Wednesday, May 22, 2019

SkillsPlus International Inc. Announces Online GMP e-Learning Courses

SkillsPlus International Inc. proudly announces  the reintroduction and updating of our very popular GMP e-learning courses. 
FDA cGMP QSR GMP Training Courses by SkillsPlus International Inc.
FDA cGMP QSR GMP Training Courses by SkillsPlus Intl Inc.


Do you need . . . ?

  • New employee GMP training awareness that is quick and easy?
  • Annual refresher training that is on a flexible schedule for team members?
  • Training solutions that are responsive to a demanding production environment?

Our LMS GMP Training solution is the answer to your needs!

  • A current list of topics is available.
  • 24-7 Availability
  • An ever growing list of topics is planned.
  • Our pricing is structured for today’s tight budgets

Additional Features

  • Private classrooms allow your company trainer to share notes to all your employees.
  • Trainers can be identified as classroom monitors to tracking student grades and completion.

Online Courses Currently Available

  • 21 CFR 211: Pure, Safe and Effective – An overview to of the Current Good Manufacturing Practice Regulation.
  • Proper Documentation Practices – An explanation of the GDPs for paper and electronic records.
  • Equipment – A review of equipment related GMPs.
  • Root Cause Analysis – An in-depth examination of the most effective tools for investigation deviations. Individual deviation specific feedback and coaching is available.
  • Investigation Report Writing – This course offers an in-depth examination of the FDA and QA expectations for writing a comprehensive investigation report. Individual report specific feedback and coaching is available.

Email us for a quote:  skillsplus@aol.com

Saturday, May 18, 2019

The Generic Drugs You're Taking May Not Be As Safe Or Effective As You Think - NPR.org

Read the full article:  The Generic Drugs You're Taking May Not Be As Safe Or Effective As You Think - NPR.org

"Eban has covered the pharmaceutical industry for more than 10 years. She notes that most of the generic medicines being sold in the U.S. are manufactured overseas, mostly in India and China. The U.S. Food and Drug Administration states that it holds foreign plants to the same standards as U.S. drugmakers, but Eban's new book, Bottle of Lies, challenges that notion. She writes that the FDA often announces its overseas inspections weeks in advance, which allows plants where generic drugs are made the chance to fabricate data and results."


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Tuesday, April 9, 2019

FDA approves first two-drug complete regimen for HIV-infected patients who have never received antiretroviral treatment - FDA.gov

Read the full press release:

FDA approves first two-drug complete regimen for HIV-infected patients who have never received antiretroviral treatment - FDA.gov

The U.S. Food and Drug Administration . . .

"approved Dovato (dolutegravir and lamivudine), as a complete regimen for the treatment of human immunodeficiency virus type 1 (HIV-1) infection in adults with no antiretroviral treatment history and with no known or suspected substitutions associated with resistance to the individual components of Dovato. This is the first FDA-approved two-drug, fixed-dose, complete regimen for HIV-infected adults who have never received treatment for HIV. 
“Currently, the standard of care for patients who have never been treated is a three-drug regimen. With this approval, patients who have never been treated have the option of taking a two-drug regimen in a single tablet while eliminating additional toxicity and potential drug interactions from a third drug,” said Debra Birnkrant, M.D., Director of the Division of Antiviral Products. “Having a drug-sparing treatment available that uses fewer drugs is beneficial to patients who may have issues taking multiple medications over a long period of time.”"


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#FDA

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Thursday, February 28, 2019

FDA plans first public hearings on legalizing CBD foods in April - CNBC

Read the full article:  FDA plans first public hearings on legalizing CBD foods in April - CNBC

"The Food and Drug Administration will hold its first public hearings on CBD in April as the agency weighs rules allowing companies to add the popular cannabis-based compound to food, Commissioner Scott Gottlieb said Wednesday. 
"We're deeply focused on this. We have taken on other hard challenges before," Gottlieb told the House Appropriations Committee on Wednesday. "You have my commitment I'm focused on this one.""

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Friday, February 8, 2019

Liquor before beer? You will still feel terrible, new study says - CNBC

Wine Lovers Dishwasher Magnet - Clean or Dirty
Wine Lovers Dishwasher Magnet - Clean or Dirty

Read the full article:  Liquor before beer? You will still feel terrible, new study says - CNBC

"... a new medical study has concluded that the threat of a crushing hangover cannot be removed by making sure that beer comes before, or after, wine. 
The study, published in the American Journal of Clinical Nutrition on Friday, went further claiming that hangovers were also not made more bearable by sticking to one type of drink thereby debunking another of the barfly's favorite: "Grape or grain but never the twain.""


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Tuesday, February 5, 2019

Amazon hints at national online pharmacy plans with new licenses - MedCity News

Read the full article:  Amazon hints at national online pharmacy plans with new licenses - MedCity News

"Pillpack’s Phoenix, Arizona facility has been granted nine additional state pharmacy licenses in the past two months, allowing that site to sell into other states, according to a research note from financial services firm Jefferies. 
The Arizona site now has active pharmacy licenses across 19 states with three applications pending. This is in addition to the company’s mail-order facilities in Manchester, New Hampshire (which has licenses in 49 states), Miami, Florida (which has licenses in 45 states) and Austin, Texas (which has licenses in 43 states). Pillpack’s New York location has licenses in only two states."

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California Designated Representative Training Courses (wholesaler, 3PL, reverse distributor) - Approved by the California State Board of Pharmacy
California Designated Representative Training Courses (wholesaler, 3PL, reverse distributor) - Approved by the California State Board of Pharmacy


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Tuesday, October 30, 2018

Thrills and Pills: Another Top 5 Scary Pharma Flicks - Pharmaceutical Manufacturing

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Read the full article:

Thrills and Pills: Another Top 5 Scary Pharma Flicks - Pharmaceutical Manufacturing

"It’s that time of year when watching a movie means snuggling up to a blood-curdling tale that will make you want to hide under the covers. And filmmakers love to tap into the collective fear of Big Pharma, bad medicines, and drug experiments gone horribly awry."

Halloween Candy Corn - FDA QSR cGMP Training Courses

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Friday, August 17, 2018

CGMP and QSR Trainer Certification Program

GMP Trainer Courses

GMP Trainer Awareness, Certification, and Master Trainer Course


This online self-study course leads participants through many different ways to teach cGMPs and QSRs. Learn what a class instructor thinks while delivering a training session to students, so you can repeat that training approach in your own organization.
  • This class is implemented in three phases: Awareness, Certification and Master Trainer.
  • This is NOT a public seminar workshop. Our public seminar was so popular, we turned it into an online self-study course that fits into your busy schedule.

Keywords:   FDA cGMP GMP QSR, Train the Trainer, Train-the-Trainer, Train-The-Trainer, GMP Trainer Certification, cGMP Trainer Certification, QSR Trainer Certification, FDA Trainer Certification, GMP Trainer Awareness Course, GMP Master Trainer Course, Training For Trainers, Trainer Education

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Tuesday, July 3, 2018

Coffee Drinkers Are More Likely To Live Longer. Decaf May Do The Trick, Too - NPR

Read the full article:

Coffee Drinkers Are More Likely To Live Longer. Decaf May Do The Trick, Too  -  NPR

"We found that people who drank two to three cups per day had about a 12 percent lower risk of death compared to non-coffee drinkers" during the decade-long study, says Erikka Loftfield, a research fellow at the National Cancer Institute."

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Thursday, June 28, 2018

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"
Shop for low prices (holding Rx bottles)
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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