fda
Animal gene-editing researchers leaving US to escape FDA’s ‘regulatory confusion’
In a few weeks, reproductive biologist Charles Long will travel from Texas to São Paulo, Brazil in search of collaborators ...
Fighting depression: Nasal-based ketamine spray clears key FDA hurdle
One of the largest hurdles to ketamine becoming a mainstream depression treatment may have just been cleared. On [February 12], ...
Viewpoint: We’re letting bureaucracy get in the way of diagnostic innovation
Should we be making it easier for companies to bring new tests to market, rather than having a process that ...
Proposed U.S. regulation of gene-edited food animals is not fit for purpose
Both plant and animal breeders need access to gene editing tools to introduce sustainability traits ...
Audio: New FDA pesticide residue study confirms America’s food supply is safe
The FDA recently released its annual Pesticide Residue Report. As pesticides are one of the things people worry most about, I ...
Unapproved stem cell treatments draw FDA investigation following bacterial infections
This year [2018], 12 people have been hospitalized with bacterial infections after being treated with stem cell products derived from ...
Viewpoint: We aren’t doing enough to protect people against ‘false promises’ of unproven stem cell treatments
In an announcement of no surprise, the U.S. Food and Drug Administration (FDA) again officially warned a company it previously warned in ...
Animal gene editing could ‘transform’ our food supply, but will ‘questionable regulations’ block innovation?
As scientists in labs across the world create virus-resistant pigs, heat-tolerant cattle and fatter, more muscular lambs, a big question looms: Will regulation, safety ...
Viewpoint: FDA’s plan to regulate gene-edited animals as drugs is a ‘failed policy’
Some bureaucrats in the Trump administration seem not to have gotten the memo about deregulation being good for innovation, the ...
CRISPR treatment for rare genetic eye disorder gains FDA study approval
Days after a Chinese researcher incensed the world of science with claims of editing the genomes of twin girls, an American ...
Boost for precision medicine? FDA approves drug targeting different cancers with shared mutation
The Food and Drug Administration on [November 26] approved a drug for a wide range of cancers based on a ...
Onto the grill: But are consumers ready to embrace—and eat—lab-grown meat?
It’s been a busy summer for food-based biotech. The U.S. Food and Drug Administration made headlines when it approved the ...
USDA, FDA approval of lab-grown protein likely to spur ‘all-out development’ of clean meat products
The virtual super nova of interest in clean meat has arrived at the regulatory stage. The FDA and USDA are ...
USDA, FDA announce plan to split regulatory oversight of lab-grown meat
The Agriculture Department and FDA laid out new details on [November 16] about how the two agencies plan to split ...
FDA reaffirms much-criticized plan to regulate genetically engineered animals as if they were a drug
FDA Commissioner Dr. Scott Gottlieb has doubled down on his agency’s failed policy for regulating an entire sector of biotechnology — the ...
Non-GMO labels mislead everybody, but may hurt poor people the most, nutritionist claims
Non-GMO labels on foods are popping up on grocery store shelves all over the US. These labels are intended to ...
Opioid controversy: FDA approves powerful new drug despite addiction concerns
In a highly controversial move, the Food and Drug Administration approved an especially powerful opioid painkiller despite criticism that the ...
Viewpoint: FDA plan to treat gene-edited animals like ‘walking drugs’ will stifle agricultural innovation
Nov. 3 marked One Health Day (www.onehealthcommission.org) – an international campaign to recognize the importance of a broad, trans-disciplinary approach ...
FDA approves 23andMe’s direct-to-consumer DNA test assessing patient’s ability to respond to antidepressants
The U.S. Food and Drug Administration (FDA) announced [October 31] that it has approved the marketing of 23andMe’s reports on ...
FDA plan to regulate a gene-edited animal as a ‘drug’ will ‘choke’ research, experts say
Despite the Trump administration's calls to increase innovation in biotechnology in a new draft proposal, experts say the classification of genetic editing ...
The stuff that ‘makes magic mushrooms so magic’ moves closer to FDA approval for treating depression
The active ingredient that makes magic mushrooms so magic—the psychedelic drug psilocybin—is one step closer to becoming a legal treatment for ...
Animal biotechnologist Alison Van Eenennaam questions FDA plan to classify CRISPR gene-edited animals as drugs
The [FDA in 2019] will roll out several guidance documents meant to provide “intensive assistance” for navigating its guidelines for ...
Quick FDA approval of GMO human insulin 36 years ago contrasts with today’s biotechnology regulatory sclerosis
This week marked the 36th anniversary of one of biotechnology’s most significant milestones—the approval by the FDA of human insulin ...
Who benefits most from FDA’s ‘accelerated’ drug approvals? Patients or drugmakers?
Increasing reliance on this and other means of moving drugs quickly to market have many critics worried, given that drugmakers ...
FDA launches initiative to support plant, animal biotechnology innovation
Today, [October 30] the U.S. Food and Drug Administration announced the Plant and Animal Biotechnology Innovation Action Plan to outline the key ...
Despite FDA safety data, media promote glyphosate scare stories to drive readership, farmer says
FDA Testing Finds No Glyphosate Residues in Over Half of Commodities Tested. And what they did find was well within ...
FDA, USDA tackle lab-grown meat label regulations at joint agency conference
[Ocotber 24 was] Day 2 of the joint USDA-FDA public meeting on cell-based meat — or whatever we end up ...
