- published: 16 Nov 2014
- views: 2863
On 11/19/14, the FDA’s Center for Drug Evaluation and Research (CDER) released its new “Validation Rules for Study Data Tabulation Model (SDTM) Formatted Studies.’’ In this webinar, the experts at P21 detail these changes and what they mean, and explain how you can leverage OpenCDISC Community 2.0 to execute against these rules.
In order to help food companies properly label their products for U.S. distribution, Registrar Corp compiled a list of some U.S. Food and Drug Administration (FDA) food and beverage labeling regulations. Join Registrar Corp to learn more about the requirements for compliance with the new FDA food labeling rules.
"Counting your calories will become easier under new government rules requiring chain restaurants, supermarkets, convenience stores — and even movie theaters, amusement parks and vending machines — to post the calorie content of food "clearly and conspicuously" on their menus. The Food and Drug Administration plans to announce the long-delayed rules on Tuesday. The regulations will apply to businesses with 20 or more locations and they will be given until November 2015 to comply.”* Ben Mankiewicz (http://www.twitter.com/benmank77) Jimmy Dore (http://www.twitter.com/jimmy_dore) and Misty Kingma (http://twitter.com/mistykingma) of The Young Turks discuss. *Read more from here http://bigstory.ap.org/article/cb5694c0fe1d4fc58fabf0a8631da159/new-fda-rules-will-put-calorie-counts-menus ****...
Is China Fueling The Drug War? http://testu.be/1GzTYHN Subscribe! http://bitly.com/1iLOHml The Food and Drug Administration is one of the world's strictest regulatory agencies. So, how do drugs get approved for use in the U.S.? Learn More: Drug Safety/Drug Approval Process http://www.fda.gov/NewsEvents/Testimony/ucm161673.htm "Modern drugs provide unmistakable and significant health benefits." House overwhelmingly passes bill to speed FDA drug approvals http://www.washingtonpost.com/blogs/wonkblog/wp/2015/07/10/house-overwhelmingly-passes-bill-to-speed-fda-drug-approvals/ "A bipartisan bill that would make significant changes to the process for developing new drugs and medical devices overwhelmingly passed the House in a 344-77 vote Friday morning." Novel New Drugs 2013 Summary htt...
Dr. Richard Besser looks at the proposed changes covering farms, processing plants.
Cigar retailers and manufacturers said a new rule from the Food and Drug Administration is wiping their entire industry off the map. Subscribe to KMBC on YouTube now for more: http://bit.ly/1fXGVrh Get more Kansas City news: http://kmbc.com Like us:http://facebook.com/kmbc9 Follow us: http://twitter.com/kmbc Google+: http://plus.google.com/+KMBC
The Food and Drug Administration will announce broad new rules for posting calorie counts on menus. The FDA wants listings just about everywhere you eat, outside your kitchen as part of a directive in the Affordable Care Act. CBS news medical contributor Dr. Holly Phillips joins "CBS This Morning" to discuss the upcoming rules.
FDA Regulations: 499 pages https://s3.amazonaws.com/public-inspection.federalregister.gov/2016-10685.pdf Royal College of Physicians Report: https://www.rcplondon.ac.uk/projects/outputs/nicotine-without-smoke-tobacco-harm-reduction-0 CASAA: http://casaa.org/ SFATA: http://sfata.org/
On September 10, 2015, the U.S. Food and Drug Administration (FDA) released its final rules for Preventive Controls for Human and Animal Food. This rule is part of FDA’s implementation of the Food Safety Modernization Act (FSMA). FDA's Preventive Controls Rules require registered food facilities to create food safety plans, monitor suppliers, and more. Join Registrar Corp to learn about requirements and compliance dates of the Preventive Controls Rules and how you can comply.
"The Rulemaking Process" video explains how laws are implemented by rules, and how rules get made in an open and transparent process. It describes how FDA publishes a proposed rule and how the public can offer comments on the proposed rule. Finally, the video explains how the Agency considers those comments before publishing a final rule and how the Agency gives companies time before a final rule becomes effective, having the force of law. For more information visit http://www.fda.gov/Food/FoodSafety/FSMA/ucm249243.htm
If the CDC was a private company, it would be in a heap of trouble with the Federal Government right now. But because the CDC IS a branch of the Federal Government, it’s in trouble with no one. But that doesn’t mean the FDA is very happy with their stance on this year’s flu outbreak. Late last week, the Centers for Disease Control and Prevention released updated figures, admitting that this year’s FLU vaccine is even worse than they first thought. Now, health officials believe the shot is 77 percent ineffective. Meaning only 23 percent of those who got the shot are even PARTLY protected from the FLU. So much for herd immunity. But as we’ve reported several times, the CDC took advantage of their own failures to prop up another expensive drug in the big pharma industry. An endorsement th...
Huge news today everyone! Please read the description below for all advocacy links #DoSomething #GetInvolved ▇▇▇▇▇▇▇▇▇▇▇▇▇▇▇▇▇▇▇▇▇▇▇▇▇▇▇▇▇▇▇▇▇▇▇▇▇▇▇▇▇▇▇▇▇▇▇▇▇▇▇▇▇▇▇▇▇▇▇▇▇▇▇▇▇▇▇▇▇▇▇ IF YOU CARE ABOUT VAPING UTILIZE THE FOLLOWING LINKS AND MAKE A DIFFERENCE. ►http://august8th.org ►http://casaa.org/ ►http://notblowingsmoke.org/ ►http://fdaregs.info/ ►http://www.r2bsmokefree.org Epic huge news today regarding the RDA Vaping Regulations, Article link and Reddit link are below. Read / share then share again. I don't have 100% of the information right now as I said the original "deeming rule" still exists in its original form. That's what we need to change. This announcement today now just gives us more time to do that. ⇨⇨https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm56...
My thoughts, such as they are.
US FDA’s new Generic labeling rule? How it will allow Generic Drug Companies to update their labels? The measures to be taken and the complexities to overcome; decode the complete guidance visually
Webinar recorded on April 6, 2017. On Tuesday, March 14th, FDA published new business rules for SDTM and SEND studies. In this webinar, Max Kanevsky of Pinnacle 21, guides you through the changes and best practices to bring clarity to your data standardization and regulatory compliance efforts.
These are the proposed FDA Rules, Regulations, and Standards to be taking place in 2 years time. Which simply means we have time to protest, fight, and knock some of the rediculous standards/rules off thier list of proposals! So lets band together as Vaper's and members of the Vaping community and beat the FDA, Big Tobacco, and Pharma at thier own game! The more people who band together in this Vaping Community the better off we are and the better chance we have of winning the fight somewhat! Please join CASAA and join the fight we all know that we need as many people as we can get to send letters, emails, and phone calls to our local Representatives, Government, FDA, and Legislative Representatives. We need to overwhelm them with these things so we can possibly knock them off thier high ...
The FSMA rule on Sanitary transport of human and animal food advances FDA’s effort to protect foods from farm to table by keeping product safe from contamination during transportation. This presentation will discuss the requirements and likely impact for all stakeholders including, brokers, loaders, transporters, and receivers.
The vaping industry says the lengthy federal reviews announced on Thursday would be time-consuming and costly. They warn that the rules could also put many smaller companies out of business. (May 5) Subscribe for more Breaking News: http://smarturl.it/AssociatedPress Get updates and more Breaking News here: http://smarturl.it/APBreakingNews The Associated Press is the essential global news network, delivering fast, unbiased news from every corner of the world to all media platforms and formats. AP’s commitment to independent, comprehensive journalism has deep roots. Founded in 1846, AP has covered all the major news events of the past 165 years, providing high-quality, informed reporting of everything from wars and elections to championship games and royal weddings. AP is the largest...
New FDA rule bans 3 food packaging chemicals with suspected cancer links