FDA

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Tweeted by @jimsabogal

"FDA Will Soon Need to Publish More Information About the Outside Standards it Uses"
http://www.raps.org/Regulatory-Focus/News/2014/11/06/20694/FDA-Will-Soon-Need-to-Publish-More-Information-About-the-Outside-Standards-it-Uses/?utm_source=social&utm_medium=post&utm_campaign=RFnews

The US government's Office of the Federal Register (OFR) has finalized a rule calling on the federal agencies, including the US Food and Drug Administration (FDA), to offer more information about third-party standards they require companies to comply with.

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Tweeted by @aawayne

"U.S. Health Chief Calls Review After Obamacare Inflation"
http://www.bloomberg.com/news/2014-11-24/u-s-health-chief-calls-review-after-obamacare-inflation.html

A "culture of increased transparency" is needed at the U.S. Health and Human Services Department, Secretary Sylvia Mathews Burwell said, after Obamacare enrollment data were padded with dental plan customers in what she has called an error.

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Tweeted by @DavidAKesslerMD

"Industry groups voice disappointment over FDA labeling rule"
http://supermarketnews.com/laws-regulations/industry-groups-voice-disappointment-over-fda-labeling-rule-0

NGA will continue to work with Congress to pass bipartisan legislation to address this regulatory overreach

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Tweeted by @foodanddruglaw

"Hatch-Bennet bill sharpens hill health IT focus — Feuding vendors join forces to make FHIR"
http://www.politico.com/morningehealth/1214/morningehealth16350.html

The Medical Electronic Data Technology Enhancement for Consumers' Health, or MEDTECH, Act joins a handful of other bills that would restrain FDA's regulatory powers in the health IT domain.

Industry groups are happy to hear it.

[briheller]

Please sign this petition to the FDA requiring better labeling of sesame https://www.change.org/p/fda-add-sesame-seeds-as-an-allergen-to-us-product-labeling-laws-require-them-to-be-disclosed-on-us-food-labels  Anyone can sign this informal petition on Change.org, but the more signatures, the more they will take notice. 

FYI:  This informal petition led to a more formal "citizen's petition" by CSPI, which is not the type that take signatures, but rather, is the type the FDA must reply to by law!  http://cspinet.org/new/201411181.html

Again, here's where to sign the original petition that started it all:  https://www.change.org/p/fda-add-sesame-seeds-as-an-allergen-to-us-product-labeling-laws-require-them-to-be-disclosed-on-us-food-labels 

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Brian,

Most of us sesame folks at FAS have already signed your petition.  I support it & the CSPI petition.  Thank you for your efforts to help those with sesame allergies.

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Tweeted by @RAPSorg

#FDA Under Fire for Perceived Lack of AdComm Transparency, and more news in today's #Regulatory Recon: ow.ly/FBKj7

http://www.raps.org/Regulatory-Focus/News/2014/12/09/20939/Regulatory-Recon-FDA-Under-Fire-for-Perceived-Lack-of-AdComm-Transparency-9-December-2014/?utm_source=social&utm_medium=post&utm_campaign=RFnews

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Tweeted by @fdaatty

"FDA, FSMA, and the USDA Budget Increases- Update from Latest Spending Bill"
http://fdaatty.com/2014/12/fda-fsma-and-the-usda-budget/


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"What's in the spending bill? We skim it so you don't have to"
http://www.washingtonpost.com/blogs/post-politics/wp/2014/12/09/whats-in-the-spending-bill-we-skim-it-so-you-dont-have-to/

There's $2.589 billion for the Food and Drug Administration, a $37 million increase from last year. There's $27 million in new funding for the Food Safety Modernization Act. The Food Safety and Inspection Service would receive $1.016 billion, a $5 million increase.

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Tweeted by @hhask

"How can FDA be Improved? Patient Groups Offer Ideas"
http://www.raps.org/Regulatory-Focus/News/2014/12/10/20958/How-can-FDA-be-Improved-Patient-Groups-Offer-Ideas/?utm_source=Email&utm_medium=Informz&utm_campaign=RF-Today

Since 2012, FDA has launched several initiatives meant to better take into account the views of patients. Some, like its patient-focused drug development initiative, have involved patients in more than a dozen meetings and solicited extensive feedback. Others, such as its medical device-focused Patient Preference Initiative (PPI) are still in the early stages of development.

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Tweeted by @WSJ

Why doesn't FDA disclose all financial ties between its advisers and device firms? Here's the short answer: on.wsj.com/1vHluxP

http://blogs.wsj.com/briefly/2014/12/08/undisclosed-ties-between-fda-advisers-and-device-firms-the-short-answer/?mod=e2tw

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The FDA says its disclosure policies are designed to balance the needs to retain public trust and recruit leading experts.

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Tweeted by @foodanddruglaw

"FDA Head Speaks Up for Science"
http://blog.ucsusa.org/fda-head-speaks-up-for-science-768

Science, Hamburg stressed throughout her speech, must inform regulatory policy. And innovation must be harnessed to science-informed regulation if it is to "bridge the gap between scientific discovery, good ideas, and meaningful products and actions to address the public health issues of today and tomorrow."

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Tweeted by @US_FDA

Objectivity key for FDA Director of Biostatistics when working toward possible cures. go.usa.gov/FPYP pic.twitter.com/1YdOiuUO3C

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http://www.fda.gov/Drugs/NewsEvents/ucm416414.htm



http://www.fda.gov/Drugs/NewsEvents/ucm426610.htm

Statisticians on both sides of the application process often have a dubious reputation of throwing cold water on any excitement.   

What sets a statistician apart

A statistician's objectivity comes in large part from our training in logic, probability theory, and the application of sound statistical methods to data analysis. Years ago, when I was training, statisticians were uniquely focused on the data.  We were the data managers, the data analysts, and the translators explaining what the data meant to non-statisticians.  Now, people from other disciplines are often involved in data manipulation, data mining, and data exploration. This can be a good thing because important information is more likely to be found when more people with diverse backgrounds are looking at the data.  A downside to this abundance of both "big data" and data analysts is that the proliferation of analyses and results can make separating true signals from noise more difficult. 

There are some data or results that statisticians might focus on a little differently than other analysts.  Our heightened awareness of uncertainty and ability to appropriately quantify that uncertainty also set us apart.  To me, statistics is not just using the tools; it's a way of thinking, a way of approaching things, and a way of interpreting results.

http://www.fda.gov/Drugs/NewsEvents/ucm426621.htm

Exploring novel statistical solutions for a development challenges both old and new

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Happy Holiday's - FDA Patient Network Newsletter - December 24, 2014

http://content.govdelivery.com/accounts/USFDA/bulletins/e342ae

This bi-weekly newsletter provided by the Office of Health and Constituent Affairs at the Food and Drug Administration (FDA) is intended to inform you of FDA-related information on a variety of topics, including new product approvals,significant labeling changes, safety warnings, notices of upcoming public meetings, proposed regulatory guidances and opportunity to comment, and other information of interest to patients and patient advocates. Subscribe or update your subscriber preferences.

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The Rulemaking Process: A Primer by FDA

https://m.youtube.com/watch?utm_medium=email&feature=share&utm_source=govdelivery&source=govdelivery&v=NGc1SUedEr0

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What is Regulatory Science? (video-full version)

https://m.youtube.com/watch?source=govdelivery&utm_medium=email&utm_source=govdelivery&v=CjeG--ik_bw