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3D-Printed Anatomical Models: FDA Explains Regulatory Framework | RAPS

The US Food and Drug Administration (FDA) on Thursday presented its case for regulating 3D-printed, patient-specific anatomical models as medical devices when they are marketed for diagnostic use at a joint meeting with the Radiological Society of North America's 3D Printing Special Interest Group.
Joel Finkle's insight:
Reasonable regulation of 3D Printing.  If it's a 'standard' item used to illustrate diagnostics or disease state, I can understand needing approval.  3D prints of personal imaging, though, needs to remain an available option to use to help patients understand and visualize.
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Drug Product Registration Process - 2017 Edition

Drug Product Registration Process - 2017 Edition | lifescienceregulatory | Scoop.it
Regulations in the United States and Europe require technologies for registration of medicinal products in a structured format to facilitate inspections, safety tracking and licensing. This paper addresses the requirements of the two current and one future standards, as well as the processes used by pharmaceutical companies to maintain such information, and suggests best practices for maintenance of such databases within a company.
Joel Finkle's insight:
New edition of my white paper comparing XEVMPD, SPL and IDMP
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European Regulatory Roundup: Lead Brexiteer Muddies Waters on UK-EMA Relationship (2 February 2017) | RAPS

Welcome to our European Regulatory Roundup, our weekly overview of the top EU regulatory news.

Joel Finkle's insight:
Will they or won't they?  I hope they keep ties to EMA post #brexit - anything else will mean huge costs in developing their own regulations.
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Trump Pledges to Gut FDA: Which Regulations Need to Go? | RAPS

With an executive order (EO) and comments from President Donald Trump yesterday calling for a massive overhaul of US Food and Drug Administration (FDA) regulations, legal experts and former FDA officials are offering some practical and creative ways the agency could clean house.

Joel Finkle's insight:
Some insight on how FDA might be streamlined under our current administration. Yes, there are some regulations that no longer apply, but it's not like they're restricting business. Public safety should remain concern #1.
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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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The Complexity of IDMP

Many pharmaceutical companies are sceptical about IDMP despite the business benefits and its contribution to patient safety.
Joel Finkle's insight:
nothing new here, but interesting to see what my former boss Paul Attridge is up to
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Vada Perkins regulatory strategist/expert consultant RIM, ISO IDMP SPL

IDENTIFICA offers comprehensive Regulatory Information Management (RIM) expertise from strategy to execution for Global Product Lifecycle Data Management (IDMP)
Joel Finkle's insight:
Vada Perkins talks about Manufacturing Establishment Information at @FDA and how it relates to #IDMP
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Proof will track your blood alcohol content with a wristband

Proof will track your blood alcohol content with a wristband | lifescienceregulatory | Scoop.it
Checking your blood alcohol content with a breathalyzer while out with some friends might just be a party trick — but if you really wanted to know it to..
Joel Finkle's insight:
More biometrics to be concerned about leaking or being used as evidence #theresanappforthat
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Suspecting arson, cops subpoena homeowner's pacemaker logs, then charge him with multiple felonies

Suspecting arson, cops subpoena homeowner's pacemaker logs, then charge him with multiple felonies | lifescienceregulatory | Scoop.it
Ross Compton, a 59-year-old homeowner in Middletown, Ohio called 911 in September 2016 to say that his house was on fire; there were many irregularities to the blaze that investigators found suspic…
Joel Finkle's insight:
Biometrics used as evidence in a crime - can you encrypt your own data, protect it from seizure?
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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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