Monday, January 16, 2017

Next up on the Trump crazy train: A man who thinks that a “Yelp for drugs” will do a better job than the FDA – Respectful Insolence

Read the full article: Next up on the Trump crazy train: A man who thinks that a “Yelp for drugs” will do a better job than the FDA – Respectful Insolence:

"a third person under consideration for the position of FDA Commissioner: Balaji Srinivasan. I had never heard of him before, but I quickly learned that Srinivasan is also a Silicon Valley entrepreneur. Like O’Neill, he is not a scientist, but rather CEO of bitcoin start-up 21.com. He is also a partner at venture firm Andreessen Horowitz and teaches at Stanford University. His primary expertise is in the area of digital payments and computational biology, and his expertise in health regulation stems from a start-up company he co-founded, Counsyl Inc., which offers DNA screening, especially for people considering having children."

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Wednesday, December 14, 2016

FDA approves first autologous cellularized scaffold for the repair of cartilage defects of the knee - FDA.gov

Press Announcements > FDA approves first autologous cellularized scaffold for the repair of cartilage defects of the knee - FDA.gov:

"The U.S. Food and Drug Administration today approved Maci (autologous cultured chondrocytes on porcine collagen membrane) for the repair of symptomatic, full-thickness cartilage defects of the knee in adult patients. Maci is the first FDA-approved product that applies the process of tissue engineering to grow cells on scaffolds using healthy cartilage tissue from the patient’s own knee."

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Monday, December 12, 2016

2016 FDA Guidance Documents You Should Know | MDDI Medical Device and Diagnostic Industry News Products and Suppliers

View the annotated list:  2016 FDA Guidance Documents You Should Know | MDDI Medical Device and Diagnostic Industry News Products and Suppliers:

"This year FDA again issued several guidance documents that have substantial, positive implications for portfolio productivity and strategy. The following 2016 guidance documents merit careful consideration by every device manufacturer." . . .

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Friday, December 9, 2016

Destroying the FDA to save it? No, more like just destroying it. – Respectful Insolence

Look into this crystal ball:  Destroying the FDA to save it? No, more like just destroying it. – Respectful Insolence:

"First the 21st Century Cures Act passes, weakening the FDA. Next, we’ll very likely end up with either a batshit nutty libertarian who doesn’t believe the FDA should require evidence of efficacy before approving drugs or a real, honest-to-goodness pharma shill as the next commissioner of the FDA. It’s going to be a long four years."

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Thursday, December 8, 2016

Monday, December 5, 2016

What the 21st Century Cures Act is, and who benefits from it - Business Insider

Read the full article: What the 21st Century Cures Act is, and who benefits from it - Business Insider:

"Sponsors of the 21st Century Cures Act call it a win-win: a fusion of funds for medical research with new rules that direct the Food and Drug Administration to approve drugs and devices with greater urgency. There's also money to help states fight the opioid epidemic, and a boost for mental health care."

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Eating a Handful of Nuts May Prevent Major Diseases | TIME

Read the full article: Eating a Handful of Nuts May Prevent Major Diseases | TIME:

"People who ate about about a handful (20g) of any type of nuts—tree nuts, like hazelnuts, walnuts, pecans and almonds, and peanuts, which are legumes—a day had nearly 30% lower heart disease rates compared to people who didn’t eat nuts, a conclusion previous data supported. But they also had a 15% lower risk of cancer and a 22% lower risk of dying prematurely of any cause. People who ate nuts regularly also cut their risk of dying from respiratory illnesses by nearly half, and they reduced their risk of diabetes by nearly 40%."

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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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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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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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