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Viewpoint: ‘Archaic’ FDA regulation hinders animal gene-editing innovation

Phil Borgic | 
Around the world, countries are experimenting, implementing, and – importantly – properly regulating gene editing in livestock. China has been ...
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Judge rebuffs lawsuit challenging FDA authority to regulate AquAdvantage GMO salmon as a drug

Patrick Clinton | 
Remember the GMO salmon? It was created by a company called AquaBounty back in 1989 and approved by the Food ...
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USDA, FDA, EPA launch website to promote ‘science-based’ agriculture biotechnology rules

[I]n recognition of January 2020 as National Biotechnology Month, the U.S. Department of Agriculture (USDA), the Food and Drug Administration ...
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Will 2020 see the debut of promising gene therapy for hemophilia A? It’s up to the FDA.

Ricki Lewis | 
Hemophilia A gene therapy has been twenty years in the making ...
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Controversial treatment for dwarfism meets clinical trial goals. Is FDA approval coming?

Damian Garde | 
A treatment for the most common cause of dwarfism met its goal of increasing height in a pivotal study, the ...
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FDA rejects Center for Food Safety objections to key ingredient in GMO Impossible Burger

The Food and Drug Administration (FDA or we) is responding to objections that it received from the Center for Food ...
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US revising GMO, gene editing rules to ensure health and environmental safety, protect innovation

Fan-Li Chou, Marcel Bruins | 
.... More than 30 years have passed since the three federal agencies that deal with agricultural products of biotechnology — ...
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99% of tested food samples ‘well below’ EPA pesticide safety limits, new USDA report shows

The U.S. Department of Agriculture (USDA) Agricultural Marketing Service (AMS) [Dec. 10] published the 2018 Pesticide Data Program (PDP) Annual ...
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Has modern agriculture ‘tainted’ your Thanksgiving dinner?

Cameron English | 
The Environmental Working Group knows how to grab headlines with ominous claims about America's food supply. In 2018, the Washington, ...
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GMOs are ‘substantially equivalent’ to conventional foods. Should they face reduced regulations?

Marc Brazeau | 
There really is no tension between patenting plants that are also found by the FDA to be substantially equivalent ...
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Former FDA Commissioner Scott Gottlieb suggests regulators may crack down on ‘confusing’ non-GMO labels

Hank Campbell | 
If FDA ever enforces its own rules, they could stop lots of nonsense labels on food, and recent comments by ...
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Foodborne illnesses strike almost 48 million Americans annually. Do we need better food safety testing?

Sasan Amini | 
In the U.S. alone, there are an estimated 47.8 million illnesses, more than 127,000 hospitalizations and 3,000-plus deaths attributed to ...
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Podcast: Can we ‘outsmart’ cancer with synthetic biology? Dr. Tim Lu talks customized disease treatments

Cameron English, Tim Lu | 
On this episode of Biotech Facts and Fallacies, Tim Lu talks to Cameron English about Senti's progress toward "outsmarting complex ...
Food Waste

EPA, USDA, FDA launch food-waste collaboration to help ‘build sustainable agricultural’ system

On October 30, 2019 the leaders of the U.S. Environmental Protection Agency, U.S. Food and Drug Administration, and U.S. Department ...
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Cotton industry prepares to commercialize FDA-approved GMO seeds to help ‘feed 500 million people’

The cotton industry hopes to launch a new market for a genetically modified cotton plant whose seeds are edible for ...
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Viewpoint: How organic, non-GMO marketing turned food labels into ‘wild west’ of deceptive advertising

Hank Campbell | 
Food labels these days are like the Wild West of dishonest advertising. Plant juice can be called milk, steak can ...
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Over 99% of farmers follow EPA pesticide rules, so why is the public scared of chemicals?

[In September] the Federal Food and Drug Administration (FDA) released its 2017 pesticide residue sampling data results. FDA concluded: “The ...
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AI and digital health devices: FDA’s new guidelines seek to ‘strike a delicate balance’ between safety and innovation

Casey Ross | 
The Food and Drug Administration has issued new guidelines on how it will regulate mobile health software and products that ...
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Viewpoint: Sen. Lisa Murkowski farm bill rider could keep GMO salmon off the market

Republicans claim to believe in free markets, at least until competition meets hometown interests. For a case study, witness Senator ...
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FDA investigation: Traces of possible carcinogens found in common heartburn meds, including Zantac, raising pharmaceutical supply chain safety concerns

Ed Silverman | 
Regulators in the U.S. and Europe are investigating why traces of a possible carcinogen were found in certain heartburn drugs, ...
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Viewpoint: FDA animal gene-editing rules boost food waste, stifle US agriculture research

Jeannine Otto | 
A proposed U.S. regulatory framework for how the FDA treats gene-edited livestock may do more than put U.S. livestock producers ...
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Patient death prompts new rules for fecal transplants: ‘Why weren’t these guidelines already in place?’

Linda Carroll | 
In June [2019], after a patient died and another was sickened from a fecal transplant that contained drug-resistant bacteria, the ...
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Viewpoint: FDA should expand drug safety test program to include new technologies, including ‘organs on a chip’

Elizabeth Baker | 
Every March, thousands of toxicologists from around the world gather for the Society of Toxicology’s annual meeting. Animal-based approaches once ...
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FDA mulling whether patients should have to pay to join clinical trials

Rebecca Robbins | 
Some [clinical trials] plan to ask participants to pay $7,000 or so to enroll. Another wanted to ask for upward ...
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Lack of regulation could slow introduction of lab-grown meat, former FDA attorney says

Adam Sharpe | 
[A] former leading FDA attorney has warned that the speed at which companies in the cell-based meat sector are developing ...
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Application for pricey gene therapy Zolgensma contained manipulated data, but drug will remain on market, FDA says

Laurie McGinley | 
The Food and Drug Administration said Tuesday [August 7]  that Novartis submitted manipulated data as part of its application for ...
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Deep dive into US stem cell clinics gives reason to worry about ‘unsafe or useless treatments’

Ed Cara | 
Medical clinics that provide largely unregulated stem cell treatments are popping up all over the U.S. But a new study ...
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