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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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)


cGMP basics training for newbies and seasoned staff

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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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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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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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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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Thursday, May 5, 2016

FDA - Extending Authorities to All Tobacco Products, Including E-Cigarettes, Cigars, and Hookah

Read more about this: Rules, Regulations & Guidance > Extending Authorities to All Tobacco Products, Including E-Cigarettes, Cigars, and Hookah - FDA.gov:

"Previously, the FDA regulated cigarettes, cigarette tobacco, roll-your-own tobacco and smokeless tobacco, but in 2016, the FDA finalized a rule – Deeming Tobacco Products To Be Subject to the Federal Food, Drug, and Cosmetic Act – which extends the FDA’s authority to include the regulation of electronic nicotine delivery systems (such as e-cigarettes and vape pens), all cigars, hookah (waterpipe) tobacco, pipe tobacco and nicotine gels, among others.

This action is a milestone in consumer protection . . ."

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Wednesday, May 4, 2016

Medical errors now 3rd leading cause of death in U.S., study suggests - CBS News

Read the full article: Medical errors now 3rd leading cause of death in U.S., study suggests - CBS News:

"Medical errors, including wrong diagnoses, botched surgeries and medication mistakes, are the third leading cause of death in the United States, a new study suggests.

Scientists from Johns Hopkins found that more than 250,000 Americans die due to medical mishaps every year, greater than the toll from any major medical condition except heart disease or cancer."

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Thursday, March 31, 2016

Talk to your doctor about health costs. It can save you money. - KevinMD.com

Learn more: Talk to your doctor about health costs. It can save you money. - KevinMD.com:

"For starters: They can talk to their doctors about these costs. According to a study my colleagues and I just published, when health care costs come up for discussion during clinical appointments, doctors and patients increasingly discuss strategies for how to lower out-of-pocket expenditures."

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Friday, March 25, 2016

Exploring better options for ACL repairs – MassDevice

Updated September 22, 2016

You might also be interested in:
NEW ACL SURGERY COULD CUT REHAB AND RECOVERY TIME IN HALF - An engineer-turned-doctor says clinical studies show real promise

- -  original post follows below  - -

Read more, and watch the animation: Exploring better options for ACL repairs – MassDevice:

"An anterior cruciate ligament (ACL) tear can be a devastating sports injury. Every year, 400,000 people, many of them teen and young adult athletes, sustain ACL injuries or tears. Martha Murray, MD, an orthopedic surgeon at Boston Children’s Hospital, worked with a team of colleagues to create a new procedure known as bridge-enhanced ACL repair (BEAR) that encourages natural healing."

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Wednesday, March 16, 2016

Contact Lens Solutions With Hydrogen Peroxide: To Avoid Injury, Follow All Instructions - FDA

Read the full article: Consumer Updates > Contact Lens Solutions With Hydrogen Peroxide: To Avoid Injury, Follow All Instructions - FDA:

"Before you use solution with hydrogen peroxide, read all warning labels and instructions. Also note that the tip of the bottle is red. The red coloring is a reminder that these products require special handling.

“You should never put hydrogen peroxide directly into your eyes or on your contact lenses,” Lepri says. That’s because this kind of solution can cause stinging, burning, and damage—specifically to your cornea (the clear surface that covers your eye).

If you use a solution that has hydrogen peroxide you absolutely must follow the disinfecting process with a “neutralizer.” A neutralizer is always sold as part of your hydrogen peroxide cleaning solution kit. It turns the peroxide into water and oxygen, making it safe to put lenses into your eyes."

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Friday, March 4, 2016

Daily Low-Dose Aspirin Linked to Reduced Risk of Certain Cancers - US News

Read the full article: Daily Low-Dose Aspirin Linked to Reduced Risk of Certain Cancers - US News:

"Taking low-dose aspirin every day may lower the overall risk of cancer by 3 percent, mostly because of larger reductions that were seen in the risk for colon and gastrointestinal tumors, researchers are reporting.

But the benefit was only seen after six years of taking aspirin almost daily, the study authors said."

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Tuesday, February 23, 2016

Obama's Pick to Lead FDA Nears Senate Confirmation - Scientific American

Read the full article: Obama's Pick to Lead FDA Nears Senate Confirmation - Scientific American:

"After a five-month delay, the US Senate is finally poised to vote on the nominee to head the US Food and Drug Administration (FDA), cardiologist and clinical trials expert Robert Califf.

On February 22, lawmakers voted to limit debate on Califf's nomination. That procedural tactic sets the stage for a final vote this week that would determine whether he will lead the FDA."

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Tuesday, February 16, 2016

Hacking of Health Care Records Skyrockets - NBC News

Read the full article: Hacking of Health Care Records Skyrockets - NBC News:

. . ."experts say health care-record hacking is skyrocketing — up 11,000 percent last year alone.

Roughly one out of every three Americans had their health care records compromised and most are completely unaware. Such hacks give criminals a wealth of personal information that, unlike a credit card number, can last forever."

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Thursday, January 21, 2016

Making Progress in Protecting Consumers from Unsafe Supplements | FDA Voice

Read Dr. Ostroff's (FDA) full comments: Making Progress in Protecting Consumers from Unsafe Supplements | FDA Voice:

"We want to expand our use of criminal investigation and enforcement tools to address serious safety-related violations and cases of intentional fraud; and further build strategic investigatory and enforcement collaborations with the Federal Trade Commission, Department of Justice, and state governments, including state health departments and attorneys general.

Ultimately our top priority is to protect the consumers who want to improve, not damage, their health and have a right to expect that dietary supplements will be safe for them and their families."

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