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IRISS

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Please join CSC and other vendors of IDMP solutions at IRISS' IDMP Vendor Showcase November 28, 29 and 30. IRISS Membership is required -- we're presenting IDMP as a Service on the 30th
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UDI Requirements Delayed

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Joel Finkle's insight:
FDA isn't ready to implement UDI for device labeling, so you've got a little more time
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EMA on Brexit: New Headquarters Locale Will be Decided by Member States | RAPS

The European Medicines Agency (EMA) on Wednesday said the agency will not be the one deciding where to move its London headquarters as it will be decided by common agreement among member state representatives.

Joel Finkle's insight:
At the recent IDMP/SPOR meeting there was a grass-roots campaign for Barcelona.
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Successfully lab-tested 3D Bioprinter for stem cells.

Successfully lab-tested 3D Bioprinter for stem cells. | lifescienceregulatory | Scoop.it
NESS ZIONA, Israel, May 25, 2016 - Nano Dimension Ltd. (NASDAQ, TASE: NNDM), a leader in the area of 3D Printed Electronics, today announced it has successfully lab-tested a proof of concept 3D Bioprinter for stem cells.
Joel Finkle's insight:
Quite cool - time to start building organs from scratch?  Needs FDA approval yet, but I can see it coming.
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10 ways desktop 3D printers are sparking a medical revolution

10 ways desktop 3D printers are sparking a medical revolution | lifescienceregulatory | Scoop.it
Desktop 3D printers have only recently become affordable enough to stand on our desks and manufacture physical objects for us, on-dem.
Joel Finkle's insight:
I haven't posted on 3D printing for a while, it seemed time for a summary of what's been going on.
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FDA declines to approve Proteus-Otsuka sensor-equipped pill, asks for more tests

FDA declines to approve Proteus-Otsuka sensor-equipped pill, asks for more tests | lifescienceregulatory | Scoop.it
The FDA declined to approve what would have been the first mass market drug to incorporate Proteus Digital Health's ingestible sensor.
Joel Finkle's insight:
This is a little odd.  Proteus is designed to track compliance of meds... but if you're not taking the combination product, how would it track it?  I'm obviously missing something here.
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Handheld 3D printing BioPen can 'draw' human stem cells for cartilage repair

Handheld 3D printing BioPen can 'draw' human stem cells for cartilage repair | lifescienceregulatory | Scoop.it
The BioPen, a breakthrough 3D printing medical device, allows surgeons to sculpt customized 3D cartilage implants made from live stem cells and a hydrogel bioink, allowing damaged tissue to regenerate directly inside the patient.
Joel Finkle's insight:
Handheld bio-sculpting! One small step toward Star Trek style healing. #bioprinting #3dprinting
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Dario All-In-One Glucometry System Now Available in U.S.

Dario All-In-One Glucometry System Now Available in U.S. | lifescienceregulatory | Scoop.it
LabStyle Innovations, a Caesarea, Israel firm, is finally making available in the U.S. its tiny all-in-one smartphone-connected glucometer. The firm received FDA clearance late last year and has had the European CE Mark since 2013.
Joel Finkle's insight:
A small device that includes the lancet, strip storage and glucose meter, synched to your smartphone.  The next step would be to build it into a phone case, but then you need 800 models. #theresanappforthat #medicaldeviceapps
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Breakthrough Molecular 3D Printer Can Print Billions of Possible Compounds

Breakthrough Molecular 3D Printer Can Print Billions of Possible Compounds | lifescienceregulatory | Scoop.it
What will 3D printers ultimately evolve into?
Joel Finkle's insight:
This is chemical fabrication, not 3dprinting. Instant lab. If these get to a reasonable price, there's no preventing counterfeit drugs (let alone recreational ones) from flooding the market... depending on how expensive the "feedstock" is. #meddevices #bioprinting
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Curbing death and injury with safer medication (2016-03-07) - ISO

Curbing death and injury with safer medication (2016-03-07) - ISO | lifescienceregulatory | Scoop.it
ISO is updating and expanding its key Identification of Medicinal Products (IDMP) standards to help stem the global toll of death and injury caused by medication errors. Medication errors and adverse drug events can occur in nearly half of all surgical procedures, according to a new study published in the October 2015 issue of  Anesthesiology1). Although focused on 277 operations involving 3 671 medication administrations at the Massachusetts General Hospital, Boston, USA, the disturbing statistic highlights the frequency of drug-related incidents, many caused by mistakes in labelling, incorrect dosage and documentation errors that are occurring on a global scale.
Joel Finkle's insight:
Excellent article on the whys and wisdom of IDMP
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3D printed at-home medical device detects anemia within seconds

3D printed at-home medical device detects anemia within seconds | lifescienceregulatory | Scoop.it

Researchers at Kansas Sate University have developed a low-cost, point-of-care 3D printed device that, when paired with a smartphone app, can detect anemia in as little as 60 seconds.

Joel Finkle's insight:

Awesome example of a 3D-printed medical device and smartphone app that, together really need regulatory approval by FDA: it diagnoses disease, not just monitors health.

But it's cool, and should be part of every Medicines Sans Frontiers kit.

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Total IDMP Solution

Total IDMP Solution | lifescienceregulatory | Scoop.it
Leverage CSC’s unique combination of software, consulting, business process services and application modernization to solve the upcoming IDMP requirements and build a controlled product lifecycle master data environment.
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Journey with CSC into IDMP

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Electronic Common Technical Document (eCTD)

Joel Finkle's insight:

FDA has updated their eCTD page... but I don't see any new information, just reorganization.

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FDA Finalizes New Regulations for Drugmakers a Decade After First Proposal | RAPS


FDA Finalizes New Regulations for Drugmakers a Decade After First Proposal

2016-08-30

After a decade of consideration, the US Food and Drug Administration (FDA) on Tuesday finalized new regulations governing drug establishment registration and drug listing for foreign and domestic firms, though the...


Joel Finkle's insight:
Establishment Registration rules finalized, finally!
Drugs must be listed for any facility where they are "manufactured, repacked, relabeled or salvaged" - but not distributed.
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The nose knows how to fight staph

The nose knows how to fight staph | lifescienceregulatory | Scoop.it
A bacterium isolated from the nose produces a new antibiotic active against resistant pathogens.
Joel Finkle's insight:
Compound isolated from bacterium can kill MRSA. Potential looks good at least for a topical anti-infective.  But I have to think that if bacteria have movies, the tag line would be "the killer is already in the host!"
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ICH Adds 14 New Observers, Adopts New Guidelines at Lisbon Meeting | RAPS

The recently renamed International Council for Harmonisation (ICH) is adding new pharmaceutical and medical device regulators, industry groups and the US Pharmacopeia into its ranks as observers.

Joel Finkle's insight:
Lots, more ICH observer nations and organizations - Bring on eCTD 4 everywhere!!!
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Can you teach old drugs new tricks?

Can you teach old drugs new tricks? | lifescienceregulatory | Scoop.it
Faced with skyrocketing costs for developing new drugs, researchers are looking at ways to repurpose older ones — and even some that failed in initial trials.
Joel Finkle's insight:
Interesting article on how drug research can reuse existing "known safe(ish)" chemicals for new indications.  Nothing particularly new, but the databases are better every day.
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FDA Issues Long-Awaited 3D Printing Guidance for Medical Devices | RAPS

The US Food and Drug Administration (FDA) has released a new draft guidance for medical device manufacturers working with additive manufacturing (AM), which is more commonly known as 3D printing.
Joel Finkle's insight:
It's good to have guidance, but this specifically excludes devices which include drugs or biologics, and requires validation of a "range of sizes" for patient-customized devices.  In addition, they express concerns about devices made on premise rather than at something like a 3d-printing lab.  All of which are reasonable... but may dampen this growing industry. #3dprinting #3dprintmeddevice
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FDA Collaborates With FTC on Mobile Health App Regulatory Tool | RAPS

FDA Collaborates With FTC on Mobile Health App Regulatory Tool | RAPS | lifescienceregulatory | Scoop.it
The US Food and Drug Administration (FDA), the Federal Trade Commission (FTC) and other regulators are looking to help health-related mobile application developers comply with the Federal Food, Drug and Cosmetics Act (FD&C Act) and other applicable laws.
Joel Finkle's insight:
FTC and FDA create tools to help determine when health apps cross the line into medical apps.  I know there's a "Most Interesting Man in the World" joke in here somewhere.... "I don't always register my apps, but when I do, they're FDA-apps" just doesn't make me laugh though. #theresanappforthat #medicalapps
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Your optimized brain: Exploring the frontier of neurostimulation

Your optimized brain: Exploring the frontier of neurostimulation | lifescienceregulatory | Scoop.it
From Hercules to Superman, humankind has always been fascinated by characters who defy the natural limits of the human body. Scientists haven’t yet figured..
Joel Finkle's insight:
More science fiction coming true: not quite to the cyberpunk brain implants of William Gibson (Neuromancer) and George Alec Effinger (When Gravity Fails), but being able to change mental states with non-invasive stimulation has a lot of potential #theresanapforthat
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FDA Requires Strong New Safety Warnings For Opioids

FDA Requires Strong New Safety Warnings For Opioids | lifescienceregulatory | Scoop.it
The Food and Drug Administration is demanding that the instructions for the most commonly prescribed opioids include so-called black box warnings about dangers of abuse, misuse, overdose and death.
Joel Finkle's insight:
Black box warnings on all opioid pain medications about addiction risk.  Probably will be ignored because, hey, they're opioids, and there's pain. The root is worker safety, and finding medications designed for long term management of pain that aren't as addictive, or hepatotoxic, or nephrotoxic....
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Target to launch digital health section of devices in 500 stores

Target to launch digital health section of devices in 500 stores | lifescienceregulatory | Scoop.it
Target has plans to launch a new digital health initiative next month online and in 500 of its 1,793 stores. Beyond knowing the stories will offer a new section for health devices, details on what, exactly, the launch will entail are scarce.
Joel Finkle's insight:
Consumer medical devices are becoming big business. 
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3D Printed Liver Tissue Leads to $30M NIH Bioresearch Grant for UCSD

3D Printed Liver Tissue Leads to $30M NIH Bioresearch Grant for UCSD | lifescienceregulatory | Scoop.it

Innovations at UCSD such as 3D bio-printed liver tissue will not only revolutionize medication testing, it has led to the NIH making their 4D hub.

Joel Finkle's insight:

3d-printed liver tissue not for transplant but for testing drugs. Very nice. #bioprinting

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3D-Printed Vertebrae Saves Man From Becoming Quadriplegic

3D-Printed Vertebrae Saves Man From Becoming Quadriplegic | lifescienceregulatory | Scoop.it

Australian surgeons made medical history in 2015 by surgically inserting two 3D-printed vertebrae into the spine of a man with Chordoma cancer, keeping the man from becoming a quadriplegic.

Joel Finkle's insight:

It's been a while since I've posted a 3D-printed surgery piece, this one is pretty cool.

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FDA Issues More Medical Device Security Guidance

FDA Issues More Medical Device Security Guidance | lifescienceregulatory | Scoop.it

New proposed FDA cybersecurity guidance is an important step in getting medical device manufacturers more focused on the risks posed by their products as they’re

Joel Finkle's insight:

Updated guidance on cybersecurity in medical devices.

I still think it's an overstated risk: the potential is there, but the value of hacking medical devices such as infusion pumps isn't that high. #cyber

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