Wednesday, November 23, 2016

Inspect your FDA Inspector Before Your Inspection | FDAZILLA BLOG

Read the full article: Inspect your FDA Inspector Before Your Inspection | FDAZILLA BLOG:

"Each investigator brings their unique perspective, experience and idiosyncrasies, the study of which is demonstrated to be a crucial element of inspection management, readiness, and preparation. With the Inspector Profile, you’ll be able to see the inspector’s:

  •  483 issue rate 
  • Total inspections 
  • Total 483s 
  • Most common citations (based on CFR), CFR description, and citation frequency 
  • Longest / shortest inspection in duration – all time, last year 
  • Total warning letters"
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Tuesday, November 15, 2016

How long will Congress wait to help Medicare seniors? | Washington Examiner

How long will Congress wait to help Medicare seniors? | Washington Examiner:

"While many medical equipment providers are making tough decisions such as cutting staff, reducing product offerings or no longer accepting new Medicare patients, others are making even more difficult choices to close their stores. As a result, seniors on Medicare have fewer places to find the products they need to stay home and comfortable. In many cases, store closures force seniors to drive farther to stores in neighboring communities 30 miles or more away. This may not seem like a big difference, but to a senior in need of oxygen therapy or a wheelchair these trips can require Herculean effort, not to mention support from family and friends."

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Friday, November 11, 2016

Cancers linked to tobacco use make up 40% of all cancers diagnosed in the United States | CDC Online Newsroom | CDC

Read the full article:  Cancers linked to tobacco use make up 40% of all cancers diagnosed in the United States | CDC Online Newsroom | CDC:

"Forty percent of cancers diagnosed in the U.S. may have a link to tobacco use, according to this month’s Vital Signs Report. Tobacco use is the leading preventable cause of cancer and cancer deaths. It causes more than lung cancer — based on current evidence, it can cause cancers of the mouth and throat, voice box, esophagus, stomach, kidney, pancreas, liver, bladder, cervix, colon and rectum, and a type of leukemia (acute myeloid leukemia)."

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Friday, November 4, 2016

Consumer expenditure on FDA regulated products: 20 cents of every dollar | FDA Voice

Read the full article:  Consumer expenditure on FDA regulated products: 20 cents of every dollar | FDA Voice:

"One of the much-cited statistics about FDA is this: that FDA-regulated products account for about 20 cents of every dollar of annual spending by U.S. consumers. Add up 20 cents of every dollar and it amounts to more than $2.4 trillion in annual consumption that includes medical products, food and tobacco."

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The FDA sure has a broad economic reach!

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FDA cGMP QSR GMP Training



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Tuesday, October 25, 2016

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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Monday, October 3, 2016

FDA Guidance for Industry: Use of the Term “Healthy” in the Labeling of Human Food Products

Read the full article: Guidance Documents & Regulatory Information by Topic > Guidance for Industry: Use of the Term “Healthy” in the Labeling of Human Food Products - FDA.gov:

"The purpose of this guidance is to advise manufacturers who wish to use the implied nutrient content claim “healthy” to label their food products as provided by our regulations."

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cGMP basics training for newbies and seasoned staff

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Wednesday, September 28, 2016

Tuesday, September 27, 2016

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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Monday, August 15, 2016

FDA Issues Long-Awaited Revised Dietary Supplement NDI Draft Guidance: FDA Law Blog

FDA Law Blog: FDA Issues Long-Awaited Revised Dietary Supplement NDI Draft Guidance:

"Last week, FDA issued for the dietary supplement industry a draft guidance document that largely doubles-down on controversial positions the Agency has previously taken. The draft guidance – “Dietary Supplements: New Dietary Ingredient Notifications and Related Issues” – replaces the draft of the same name that was issued in July 2011."

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Read the FDA guidance:
Dietary Supplements: New Dietary Ingredient Notifications and Related Issues: Guidance for Industry - Draft Guidance (PDF)


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Monday, August 8, 2016

Protecting the Public and Especially Kids from the Dangers of Tobacco Products, Including E-Cigarettes, Cigars and Hookah Tobacco | FDA Voice

Read the full blog post: Protecting the Public and Especially Kids from the Dangers of Tobacco Products, Including E-Cigarettes, Cigars and Hookah Tobacco | FDA Voice:

. . . "federal law now prohibits retailers from selling e-cigarettes, hookah tobacco or cigars to people under age 18"

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You might also be interested in:
To support the public health goals of the Tobacco Control Act, FDA provides guidance to help industry understand and comply with all regulations and the law

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Friday, July 22, 2016

Basic GMP Training - A course focusing on cGMP basics

This live onsite course teaches the FDA cGMP basics, "Essentials for Pharmaceutical Manufacturers."

Designed for new employees and refresher GMP training for your seasoned staff.

cGMP basics training for newbies and seasoned staff

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Root Cause Analysis & Deviation Investigation Report Writing - cGMP Training
Our most popular course
Qualstar - Pharmaceutical Simulation - Advanced cGMP Training
Put fun back into GMP training!














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Thursday, July 14, 2016

Obesity More Deadly for Men Than Women: Study - philly.com

Read the full article: Obesity More Deadly for Men Than Women: Study - philly.com:

"In a study of nearly 4 million men and women around the globe, the risk of dying before the age of 70 was 19 percent for men and 11 percent for women of normal weight.

But that risk jumped to 30 percent and 15 percent, respectively, for obese men and women. That's an absolute increased risk of 11 percent for men and 4 percent for women, the researchers reported."

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Tuesday, July 12, 2016

Summer 2016 Update On ED Drugs Viagra / Cialis / Levitra: Medical And Legal Developments - Drug Injury Watch

Read the full article: Summer 2016 Update On ED Drugs Viagra / Cialis / Levitra: Medical And Legal Developments - Drug Injury Watch:

"In late June 2016 the Food and Drug Administration (FDA) said it will study a potential link between melanoma skin cancer and erectile dysfunction (ED) drugs such as Viagra, Cialis, and Levitra.

This announcement appeared in the agency's latest watch list of drugs with possible safety issues, "January - March 2016: Potential Signals of Serious Risks/New Safety Information Identified from the FDA Adverse Event Reporting System (FAERS)". In relevant part, the document listed these drugs which have been associated with melanoma as a serious side effect."

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Root Cause Analysis & Deviation Investigation Report Writing - cGMP Training
Our most popular course
Qualstar - Pharmaceutical Simulation - Advanced cGMP Training
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Friday, June 3, 2016

Stroke survivors walk again after 'unprecedented' trial at Stanford - CNBC

Read the full article: Stroke survivors walk again after 'unprecedented' trial at Stanford - CNBC:

""This wasn't just, 'They couldn't move their thumb, and now they can.' Patients who were in wheelchairs are walking now," Steinberg went on to add."

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Friday, May 6, 2016

In Prince's Age Group, Risk Of Opioid Overdose Climbs : Shots - Health News : NPR

Read the full article: In Prince's Age Group, Risk Of Opioid Overdose Climbs : Shots - Health News : NPR:

"In 2013 and 2014, according to the The Centers for Disease Control and Prevention, people ages 45 to 64 accounted for about half of all deaths from drug overdose. Prince died on April 21 at his home and music studio, Paisley Park, in Minneapolis. He was 57."

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