fda
Viewpoint: FDA should expand drug safety test program to include new technologies, including ‘organs on a chip’
Every March, thousands of toxicologists from around the world gather for the Society of Toxicology’s annual meeting. Animal-based approaches once ...
FDA mulling whether patients should have to pay to join clinical trials
Some [clinical trials] plan to ask participants to pay $7,000 or so to enroll. Another wanted to ask for upward ...
Lack of regulation could slow introduction of lab-grown meat, former FDA attorney says
[A] former leading FDA attorney has warned that the speed at which companies in the cell-based meat sector are developing ...
Application for pricey gene therapy Zolgensma contained manipulated data, but drug will remain on market, FDA says
The Food and Drug Administration said Tuesday [August 7] that Novartis submitted manipulated data as part of its application for ...
Deep dive into US stem cell clinics gives reason to worry about ‘unsafe or useless treatments’
Medical clinics that provide largely unregulated stem cell treatments are popping up all over the U.S. But a new study ...
GMO Impossible Burger soy ingredient that ‘bleeds’ approved by FDA, clearing way for US grocery store sales
The U.S. Food and Drug Administration on [July 31] approved a key ingredient in plant-based burger patties made by Impossible ...
Curaleaf’s unproven claims that CBD treats cancer, Alzheimer’s, chronic pain draws FDA warning
The company Curaleaf claims that it has developed products that can treat a slew of the most formidable conditions found ...
Bipartisan congressional group urges FDA to develop ‘workable’ GMO, CRISPR-edited animal rules
More than 20 House Energy & Commerce Committee members sent a letter to acting FDA Commissioner Ned Sharpless on [July 26] ...
Podcast: AI-powered nutrition devices could cut exploding obesity rates. Will FDA rules keep them off the market?
Medical devices powered by artificial intelligence could help overweight people customize diets based on their biomarkers ...
Viewpoint: FDA ‘accelerated’ drug approvals offer relief for critically ill patients. But more could be done.
Desperately-needed therapies often warrant early approvals ...
Viewpoint: FDA’s CRISPR-edited animal rules threaten US farming innovation
“Keep America First in Agriculture” was launched June 25 by the National Pork Producers Council, stressing the need for establishing ...
FDA rejects call for USDA takeover of CRISPR gene-edited animal regulation
The Food and Drug Administration is standing its ground in the latest battle over its regulatory turf, warning livestock groups ...
‘Uncharted territory’: Doctors struggle with patient demand for unproven CBD supplements
[Jacqueline] French, a neurologist at New York University’s Langone Health, tries to steer her patients away from sprinting to the ...
FDA warns kratom sellers to stop making unproven claims about chronic pain, opioid addiction benefits
The Food and Drug Administration is still pressing down hard on kratom—the plant treatment that adherents say has helped them ...
FDA regulatory dilemma: Are fecal transplants drugs, human tissue, or something new?
For the past several years, the U.S. Food and Drug Administration has been trying to figure out how to regulate ...
Trump executive order streamlining biotech rules won’t speed CRISPR animal approvals, livestock industry says
The executive order that the Trump administration announced [in June 2019] to streamline the approval process for agricultural biotechnology has ...
Controversial new drug meant to increase sexual desire in women is approved for sale
The Food and Drug Administration approved a controversial drug meant to increase women’s desire for sex, a treatment that has ...
Milk without cows? Biotech startup recreates dairy proteins in the lab
Lab-grown meat is getting a lot of attention along with plant-based meat substitutes. Technology is driving the industry toward providing ...
Viewpoint: US government’s clinical trial registry plagued by ‘bogus’ patient-funded stem-cell trials
When a judge ruled [June 3] that the FDA could stop the work of U.S. Stem Cell, the firm’s trials ...
Viewpoint: FDA must do more to protect consumers from ‘outright fraud’ of dietary supplements
Dietary supplements are often ineffective, if not dangerous. What does the path to supplement legislation and regulation look like? ...
Why an FDA legal victory won’t stop controversial stem cell clinics
When the Food and Drug Administration won a landmark lawsuit [June 3] against a stem cell company, health officials hailed ...
Viewpoint: Consumers shouldn’t trust paid anti-GMO activists over independent biotech experts
Despite the benefits of GMOs, 80% of respondents to the 2018 Food and Health Survey Report from the International Food Information ...
Ethical ‘quagmire’: How one ALS patient got in line for a therapy never tested in humans
The FDA gave Jaci Hermstad, a 25-year old Iowan who is dying from a rare form of ALS, an early ...
Cancer patients should get quicker access to unapproved drugs through FDA ‘concierge service’
The Food and Drug Administration plans to provide “concierge service” to doctors seeking access to unapproved drugs for cancer patients ...
These dietary supplements could slow your aging. But they might also increase your cancer risk.
As the world’s aging population grows rapidly, so has its appetite for health tips, tricks and products that could help ...
Congress renews ban on editing human embryos, despite calls from scientists touting research benefits
A House committee on Tuesday [June 4] restored to pending legislation a ban on altering the genomes of human embryos ...
FDA cracking down on unregulated dietary supplements, which it contends are almost all ineffective
The FDA recently announced that it plans to increase its oversight of the multi-billion dollar supplement industry. This would include ...
