FDA

[LinksEtc]

Tweeted by @RAPSorg

"FDA Says It's Not Interested in Regulating Most Mobile Apps or Wearable Devices"
http://www.raps.org/Regulatory-Focus/News/2015/01/16/21102/FDA-Says-Its-Not-Interested-in-Regulating-Most-Mobile-Apps-or-Wearable-Devices/?utm_source=social&utm_medium=post&utm_campaign=RFnews

Will the US Food and Drug Administration (FDA) ever regulate your FitBit, Apple iWatch or calorie-tracking mobile apps? Almost certainly not, the regulator confirmed today in a new draft policy document covering all "low-risk" general wellness devices.

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General Wellness: Policy for Low Risk Devices

Draft Guidance for Industry and Food and Drug Administration Staff

http://tinyurl.com/oyy5gym

[LinksEtc]

Tweeted by @ElaineSchattner

"Why the FDA should regulate lab tests"
http://www.modernhealthcare.com/article/20150110/MAGAZINE/301109983/why-the-fda-should-regulate-lab-tests

The Food and Drug Administration's proposal to regulate the accuracy of laboratory-developed tests has drawn heated opposition from the laboratory testing industry, hospitals and most medical specialty societies.

Medical practitioners and the public deserve protection from test purveyors making unproven claims.

[LinksEtc]

Tweeted by @MedscapeAllergy

Suspend Dozens of Drugs Based on Flawed Studies, EMA Says
Robert Lowes
January 23, 2015

(Medscape links often show personal info of person linking so I think that I will stop using them  )

A committee of the European Medicines Agency (EMA) has recommended suspending the sale of roughly four dozen generics for conditions such as diabetes, depression, and hypertension because their approvals were based on flawed clinical studies conducted in India, the agency announced today.

According to the FDA statement, the agency inspected GVK Biosciences in September 2014 on the heels of the French inspection in May 2014 and failed to find any evidence "that affects the safety or efficacy of drug products subject to pending applications or products approved in the US."

[LinksEtc]

 FDA Citizen Petition Tracker

http://www.fdalawblog.net/fda_law_blog_hyman_phelps/files/CPTracker.xls

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The Federal Register
The Daily Journal of the United States Government

https://www.federalregister.gov

[LinksEtc]

Tweeted by @EricTopol

"This Medical Supercomputer Isn't a Pacemaker, IBM Tells Congress"
http://www.bloomberg.com/news/articles/2015-01-29/this-medical-supercomputer-isn-t-a-pacemaker-ibm-tells-congress

The effort to protect decision support tools like Watson from Food and Drug Administration regulation is part of a proposal by the Republican chairman of the House Energy and Commerce Committee, Michigan's Fred Upton. Called the 21st Century Cures initiative

IBM has called current regulations outdated. "It is important to recognize that the current Food and Drug Administration regulatory framework was largely developed during the decades before the rise of today's sophisticated IT technologies,"

[LinksEtc]

Tweeted by @foodanddruglaw

"FDA takes steps to make sure defibrillators work"
http://www.washingtonpost.com/national/health-science/fda-takes-steps-to-make-sure-debrillators-work/2015/01/28/96b632b0-a701-11e4-a7c2-03d37af98440_story.html

One company, for example, had fixed a defect in one of its devices on a case-by-case basis but had never sought to systematically check and fix the issue in all the units it had sold. Other companies had relied on suppliers for various components, such as batteries and electrodes, that didn't meet certain standards.

&


"Washington Calls for a Single Regulatory Agency for Food"
http://www.foodsafetymagazine.com/news/washington-calls-for-a-single-regulatory-agency-for-food/

Lawmakers are talking about what the food industry itself has bantered about for years: creating a single food safety agency, bringing together the oversight functions of the U.S. Food and Drug Administration (FDA), U.S. Department of Agriculture (USDA) and other agencies.

[LinksEtc]

"Will FDA Have to Change its Name? New Bill Takes the 'Food' out of FDA"
http://www.raps.org/Regulatory-Focus/News/2015/01/29/21202/Will-FDA-Have-to-Change-its-Name-New-Bill-Takes-the-Food-out-of-FDA/?utm_source=social&utm_medium=post&utm_campaign=RFnews

The bill, known as the Safe Food Act of 2015, is set to strip several regulatory bodies of their authority to regulate food products and transfer that authority to a new regulator, the Food Safety Administration (FSA), whose sole job would be to regulate food.

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http://delauro.house.gov/images/pdf/SafeFoodAct2015FINALBill.pdf

[LinksEtc]

Tweeted by @bmarler


FDA seeks $4.9 billion for FY 2016 to implement the FDA Food Safety Modernization Act and improve the quality and safety of the medical products Americans use
FY 2016 request reflects a nine percent increase from FY 2015 budget

http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm432600.htm?source=govdelivery&utm_medium=email&utm_source=govdelivery#.VM_bawmUpy5.twitter

"This budget accurately reflects the challenges FDA faces in a global regulatory environment, which is becoming increasingly complex and scientifically demanding," said Commissioner Margaret A. Hamburg, M.D. "As FDA's mission expands on several fronts –– from the regulation of tobacco products to supporting the development of personalized medicine to ushering in a new era of food safety – we must possess the resources to run a modern agency that fosters innovation and ensures the safest possible drug and food supply for the American people."

[LinksEtc]

Tweeted by @owenmp

"U.S. FDA Commissioner Margaret Hamburg to step down"
http://www.reuters.com/article/2015/02/05/us-fda-hamburg-resignation-exclusive-idUSKBN0L90GT20150205?irpc=932

Hamburg's resignation comes at a crucial time for the FDA as Congress pushes initiatives to speed new drug development, and food safety advocates, backed by Obama, back the creation of a separate agency combining the food safety functions of the FDA and the U.S. Department of Agriculture.

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Tweeted by @TomBurtonWSJ


FDA Commissioner to Resign
Dr. Margaret A. Hamburg to Step Down in March
http://www.wsj.com/article_email/u-s-fda-commissioner-to-resign-1423120471-lMyQjAxMTE1ODAxNTAwOTU3Wj

Her temporary replacement will be the FDA's chief scientist, Dr. Stephen Ostroff. One possible permanent successor is Robert Califf of Duke University, whom Dr. Hamburg recently selected as her deputy commissioner for medical products and tobacco.

The new FDA commissioner will require approval from the Republican-controlled Congress.

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Tweeted by @MedscapeAllergy


FDA Commissioner Dr Margaret Hamburg to Step Down
Lisa Nainggolan and Robert LowesDisclosures
February 05, 2015
Medscape

This pressure to grease the track for drug and device makers at the expense of safety, she said, could become more intense if Republican lawmakers, now in control of both the House and Senate, manage to enact their 21st Century Cures initiative. It is designed, in their words, "to accelerate the pace of cures and medical breakthroughs."

[LinksEtc]

Tweeted by @bmarler


"The Takeaway: Obama Proposes Radical Overhaul of Nation's Food Safety Operations"
http://www.marlerblog.com/legal-cases/the-takeaway-obama-proposes-radical-overhaul-of-nations-food-safety-operations/#.VNQO-H-9KSN

Wil S. Hylton is the author of a terrifying New Yorker article about lax food safety titled, "A Bug in the System: Why Last Night's Chicken Made you Sick." Food safety lawyer Bill Marler is the man leading the charge against unsafe food in Hylton's story.

Together they weigh in on the president's proposal and the state of food safety in America.

[LinksEtc]

"FDA Confirms it Won't Regulate Apps or Devices Which Store Patient Data"

http://www.raps.org/Regulatory-Focus/News/2015/02/06/21269/FDA-Confirms-it-Wont-Regulate-Apps-or-Devices-Which-Store-Patient-Data/?utm_source=social&utm_medium=post&utm_campaign=RFnews

FDA's approach was clear: It would take a risk-based approach that would leave most consumer devices free from regulatory requirements (such as registration with FDA, meeting good manufacturing practices or filing premarket applications) as long as they did not make disease-specific claims.

Now the agency is finalizing its approach toward two types of products: Mobile medical applications ("apps") and medical device data systems.

[LinksEtc]

Tweeted by @ivanoransky


"FDA has repeatedly hidden evidence of scientific fraud," says author of new study
http://retractionwatch.com/2015/02/09/fda-repeatedly-hidden-evidence-scientific-fraud-says-author-new-study/


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Are Your Medications Safe?
The FDA buries evidence of fraud in medical trials. My students and I dug it up.

http://tinyurl.com/mavnxq6

That misconduct happens isn't shocking. What is: When the FDA finds scientific fraud or misconduct, the agency doesn't notify the public, the medical establishment, or even the scientific community that the results of a medical experiment are not to be trusted. 

The FDA has repeatedly hidden evidence of scientific fraud not just from the public, but also from its most trusted scientific advisers, even as they were deciding whether or not a new drug should be allowed on the market.

[LinksEtc]

Tweeted by @ElaineSchattner


"FDA Okays 23andMe Gene Carrier Test, Proposes Premarket Exemption For Others"
http://www.forbes.com/sites/davidkroll/2015/02/19/fda-okays-23andmes-direct-to-consumer-gene-carrier-testing-starting-with-bloom-syndrome/

home-use genetic testing for other carrier genes will be exempt from premarketing approval

The FDA believes that in many circumstances it is not necessary for consumers to go through a licensed practitioner to have direct access to their personal genetic information.

The regulatory argument had been that providing such medical results should be done only by a trained and credentialed medical intermediary

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Tweeted by @CMichaelGibson


"23andMe Gains U.S. FDA Approval for First Genetic Test Kits"
https://www.bloomberg.com/news/articles/2015-02-20/23andme-gains-u-s-fda-approval-for-first-genetic-test-kits

the genetic-testing company backed by Google Inc.

approval of 23andMe's test for Bloom syndrome

The approval also opens the way for 23andMe to pursue its ambitious plan to become a repository for humanity's genetic makeup, and to turn data gathered from $99 saliva tests sold to consumers into multimillion-dollar deals with drugmakers who want the information to help develop drugs.

[LinksEtc]

Tweeted by @Paulflevy

"CRE, ERCP, FDA, but not you and me"
http://runningahospital.blogspot.com/2015/02/cre-ercp-fda-but-not-you-and-me.html?spref=tw

I was struck by the need for an FDA announcement to users of duodenoscopes—the endoscopes used in endoscopic retrograde cholangiopancreatographies, or ERCPs--that they should be extra careful about cleaning the scopes to avoid transmittal of drug resistant bugs.

So, people knew about this problem:  MDs, the AGA, the FDA, the manufacturers.  Everybody but you and me.

[LinksEtc]

Tweeted by @foodanddruglaw

"Free the Tweets: Group Asks FDA to Allow its Scientists to Use Social Media"
http://www.raps.org/Regulatory-Focus/News/2015/03/19/21765/Free-the-Tweets-Group-Asks-FDA-to-Allow-its-Scientists-to-Use-Social-Media/

The findings, outlined in the report "Grading Government Transparency: Scientists' Freedom to Speak (and Tweet) at Federal Agencies," are meant to spur discussion about whether FDA's employees are free to speak out on issues in an unofficial capacity.

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"Grading Government Transparency: Scientists' Freedom to Speak (and Tweet) at Federal Agencies (2015)"
http://www.ucsusa.org/center-science-and-democracy/promoting-public-access-science/grading-government-transparency-2015#.VQweCH-9KSM

In 2013, more than two years after the Obama administration had issued a directive ordering reform of federal scientific integrity policies—including those governing media access—we published the first version of Grading Government Transparency. This new report added social media policies to the mix, and expanded the number of agencies to 17.