FDA

[LinksEtc]

"FDA Pegs Food Industry With Primary Responsibility For Implementing And Monitoring FSMA Reforms"
http://www.foodsafetymagazine.com/fsm-edigest/fda-pegs-food-industry-with-primary-responsibility-for-implementing-and-monitoring-fsma-reforms/

by placing primary responsibility for food safety on the industry itself, FDA intends to dedicate its resources to providing technical expertise, setting and fostering compliance with food safety standards, responding to food safety problems should they nevertheless occur, learning from problems and modifying protocols as needed.

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Operational Strategy for Implementing the FDA Food Safety Modernization Act (FSMA)
Protecting Public Health by Strategic Implementation of Prevention-Oriented Food Safety Standards   
May 2, 2014

http://www.fda.gov/Food/GuidanceRegulation/FSMA/ucm395105.htm


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"FDA Operations Team Prepares to Implement Food Safety Laws"
http://blogs.fda.gov/fdavoice/index.php/2014/05/fda-operations-team-prepares-to-implement-food-safety-laws/

[LinksEtc]

Tweeted by @LNelsonMD

"FDA gives controversial doc green light to restart work"
http://www.usatoday.com/story/news/nation/2014/06/25/burzynski-trial-reopens/11353085/

The Food and Drug Administration has given a controversial Houston doctor the green light to resume administering experimental cancer treatments.

"This puts patients at risk," says Peter Adamson, chairman of the Children's Oncology Group and chief of clinical pharmacology and therapeutics at the Children's Hospital of Philadelphia.

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Tweeted by @Skepticscalpel

"Texas medical board charges controversial cancer doctor"
http://www.usatoday.com/story/news/nation/2014/07/24/new-charges-for-burzynski/13111483/

Jaffe says the board, which put Burzynski on probation from 1994 to 2004, is "under tremendous pressure to take away Burzynski's license" because of negative publicity that Burzynski has received in recent years.

[LinksEtc]

http://www.fda.gov/Food/NewsEvents/ConstituentUpdates/ucm398828.htm

The U.S. Food and Drug Administration (FDA) is announcing a public meeting on the following two proposed rules that appeared in the FEDERAL REGISTER on March 3, 2014:

“Food Labeling: Revision of the Nutrition and Supplement Facts Labels”

“Food Labeling: Serving Sizes of Foods That Can Reasonably Be Consumed At One-Eating Occasion; Dual-Column Labeling; Updating, Modifying, and Establishing Certain Reference Amounts Customarily Consumed; Serving Size for Breath Mints; and Technical Amendments.”

FDA will discuss the proposed rules aimed at updating nutrition information and serving size requirements on the Nutrition and Supplement Facts labels to provide consumers with information that could be used to maintain healthy dietary practices. The meeting will be held June 26, 2014

[LinksEtc]

"In Unprecedented Project, FDA Prepares to Free its Own Data"
Posted 03 February 2014
http://www.raps.org/focus-online/news/news-article-view/article/4582/#

In May 2012, the White House instructed the FDA and other federal agencies to immediately begin implementing a new "digital strategy" aimed at making governmental information more readily and easily accessible to the public.

Open APIs would hypothetically allow people to access the raw data FDA puts out through its various databases-approvals, adverse event reports, recall notices, etc-and repurpose them, potentially making them easier to use or more enjoyable to read.

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"DIGITAL GOVERNMENT:BUILDING A 21st CENTURY PLATFORM TO BETTER SERVE THE AMERICAN PEOPLE"

http://www.whitehouse.gov/sites/default/files/omb/egov/digital-government/digital-government-strategy.pdf

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https://open.fda.gov/


"FDA launches openFDA to provide easy access to valuable FDA public data"
http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm399335


http://thehill.com/policy/healthcare/207922-open-fda-project-releases-millions-of-reports#.U44lV0mtg3g.twitter

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Tweeted by @ElaineSchattner

"How the FDA Unlocked Millions of Files on Drug Side Effects"
http://www.businessweek.com/articles/2014-06-05/how-the-fda-unlocked-millions-of-files-on-drug-side-effects

The Food and Drug Administration this week released software designed to let people tap into 3.6 million reports about drug side effects.

[LinksEtc]

"FDA, tech leaders talk regs and innovation at health IT hearing"
http://www.modernhealthcare.com/article/20140624/NEWS/306249932/fda-tech-leaders-talk-regs-and-innovation-at-health-it-hearing

“From an FDA standpoint, we want to engage in smart regulation, (which) means knowing when to regulate, and how to regulate,” said Jeff Shuren, the director of FDA's device center. “We're trying to provide greater predictability, and clarity. And we're trying to get out of the way,” he said, citing the agency's decisions to “deregulate scores of technologies” from apps to medical-device-data-systems.

[LinksEtc]

Tweeted by @marionnestle

"FDA Issues Guidance on Use of Nanotechnology by Food and Cosmetics Industries"
http://www.fda.gov/Food/NewsEvents/ConstituentUpdates/ucm402781.htm

[LinksEtc]

"The crucial FDA nutrition label battle you probably don’t know about, but should"
http://www.washingtonpost.com/blogs/wonkblog/wp/2014/07/02/the-crucial-fda-nutrition-label-battle-you-probably-dont-know-about-but-should/?Post+generic=%3Ftid%3Dsm_twitter_washingtonpost

For the first time in more than a decade, the FDA was mulling over making significant changes to the Nutrition Facts label (pdf) found on just about every food item sitting on grocery store shelves around the nation. More than five months later, the agency is still hearing vehement support from a number of advocacy groups and vicious dissent from several major food associations, and much of it is about one subtle but crucial proposed addition: an "added sugar" label.

[LinksEtc]

Tweeted by @bmarler


"FDA losing battle against tainted imported food"
http://seattletimes.com/html/nationworld/2023988311_fdaimportsxml.html#.U7f7VtS6KlQ.twitter

The FDA has been outgunned and overmatched for years as a rising tide of imported food has found a place at the U.S. dinner table. For budget reasons, only 1 to 2 percent of food imports are physically inspected by the agency. Congressional funding has lagged, and consumers continue to become sick.

&


"Industry Rep Questions the Resources Devoted to Antibiotic Resistance Research, Prevention"
http://www.foodsafetynews.com/2014/08/industry-representative-questions-the-resources-devoted-to-antibiotic-resistance-research-prevention/#.U-1AHn-9KSN

When it comes to fighting antibiotic resistance, Richard Carnevale of the Animal Health Institute, which represents the veterinary pharmaceutical industry, wonders, “Are we putting more resources into this than need be?”

[LinksEtc]

US FDA issues draft strategic priorities document
By Gareth MacDonald+, 02-Jul-2014

The US FDA has set emphasising the benefits of QbD, traceability and risk based manufacturing facility inspections as strategic priorities for the next four years in document published for consultation this week.

http://www.in-pharmatechnologist.com/Regulatory-Safety/US-FDA-issues-draft-strategic-priorities-document

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"FDA aims to stay the course in new 4-year plan"
http://www.massdevice.com/news/fda-aims-stay-course-new-4-year-plan

The FDA today revealed a draft version of its 4-year plan, laying out strategic priorities and goals for keeping patients and consumers safe while addressing industry concerns.

[LinksEtc]

"Toward More Comprehensive Food Labeling"
http://www.nejm.org/doi/full/10.1056/NEJMp1402971?query=featured_home#.U8cQN6gFKCw.twitter

The Food and Drug Administration (FDA) is proposing to revise the Nutrition Facts label that must appear on virtually all packaged foods in the United States. The agency's proposals are strong, urgently needed, and likely to make an important contribution to consumer behavior. But I believe they don't go far enough — additional labeling requirements can do more to influence food choices, reduce obesity, and promote health.

[LinksEtc]

"Ruling on FDA’s Oversight of Animal Antibiotic Use Called a ‘Big Blow to Public Health’"
http://www.foodsafetynews.com/2014/07/appeals-court-rules-fda-not-required-to-hold-hearings-on-animal-antibiotic-use/

“Today’s decision allows the FDA to openly declare that a particular animal drug is unsafe, but then refuse to withdraw approval of that drug,” wrote Judge Robert Katzmann in his dissent. “It also gives the agency discretion to effectively ignore a public petition asking it to withdraw approval from an unsafe drug. I do not believe the statutory scheme can be read to permit those results.”

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"FDA Doesn’t Have to Ban Antibiotics Given to Food-Producing Livestock"
http://blogs.wsj.com/pharmalot/2014/07/24/fda-doesnt-have-to-ban-antibiotics-given-to-food-producing-livestock/

Centers for Disease Control and Prevention in a report last year that recommended minimizing inappropriate use.

As for the FDA, a spokeswoman writes us that “the FDA is currently reviewing the decision but is pleased with the outcome.”

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Tweeted by @sewellchan

"The F.D.A.’s Blatant Failure on Food"
http://www.nytimes.com/2014/07/31/opinion/the-fda-blatant-failure-on-food.html?smid=tw-share&_r=3

The F.D.A. has issued a toothless voluntary guidance document for the industry, which requires no action to reduce antibiotic use and will therefore do little to nothing to stop the spread of antibiotic-resistant superbugs.

[LinksEtc]

Curious how the

FDA Voice blog
http://blogs.fda.gov

is so active while the

Transparency blog
http://fdatransparencyblog.fda.gov

has been abandoned.

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Reminds me of this

"FDA Commish to Employees: Take the FDA Back!"
http://invivoblog.blogspot.com/2009/04/fda-commish-to-employees-take-fda-back.html

The FDA is now defined by others. You must speak up and take the FDA back. It is yours, not theirs. You do more good, day in and day out, than most others, inside or outside government.

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It's "look what a great job we're doing" while they block out criticism, ideas, & issues they don't want to deal with.  They want to control the conversation, agenda, & narrative.

Just my opinion / 2 cents.

As a citizen who was active in the transparency effort, I am disappointed that I no longer sense that they are sincere in their commitment to transparency.

[LinksEtc]

"FDA's Culture of Secrecy Will Beat Obama"
http://www.lasiknewswire.com/2009/10/fdas-culture-of-secrecy-will-beat-obama.html

FDA silence about its own investigations is discretionary, not required. When the public and President Obama were upset about contaminated peanut butter, the agency fell over itself to talk about its diligent investigations into Peanut Corporation of America. Beyond the limelight, however, small enforcement matters that millions don't care about are routinely hidden because the agency's culture is more comfortable with not having to explain itself.

Culture of Secrecy.

[LinksEtc]

"As More Imported Foods Reach the Dinner Table, Holes Remain in the FDA Safety Net"
http://www.foodsafetynews.com/2014/07/as-more-imported-food-reach-the-dinner-table-holes-remain-in-fda-safety-net/

FDA has been outgunned and overmatched for years as a rising tide of imported food has found a place at the U.S. dinner table. Because of budget constraints, ordinarily only 1 to 2 percent of food imports are physically inspected by the agency at the border each year.

[LinksEtc]

"BPA-Free Plastic Containers May Be Just as Hazardous"
http://www.scientificamerican.com/article/bpa-free-plastic-containers-may-be-just-as-hazardous/

In 2012 the U.S. Food and Drug Administration banned the sale of baby bottles that contain bisphenol A (BPA), a compound frequently found in plastics.

recent research reveals that a common BPA replacement, bisphenol S (BPS), may be just as harmful.