Category: Regulations
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FDA Issues Guidance on Patient Experience Data Collection
The Food and Drug Administration issued draft regulatory guidance outlining methods for collecting data from patients that the agency says will help improve evaluations of more precisely targeted drugs.
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Infographic – Cloning Gains More U.S. Support
Although still a minority, about 4 in 10 of those polled by the Gallup organization in May of 2018 say they find the cloning of animals morally acceptable, a marked increase from 2010 and 2002.
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FDA Delays Crispr Trial for Inherited Blood Diseases
The U.S. Food and Drug Administration put a hold on beginning a clinical trial of the emerging genome editing technique known as Crispr to treat inherited blood disorders.
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Immunotherapy Trial Shows Increased Brain Cancer Survival
Results from a clinical trial show an experimental treatment for an aggressive form of brain cancer that harnesses the immune system extends patients’ survival, when combined with standard cancer care.
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FDA Okays A.I.-Guided Wrist Fracture Software
The U.S. Food and Drug Administration authorized marketing of software to help diagnose wrist fractures using machine-learning algorithms to read and interpret X-ray images.
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FDA Urges More Industry Sun Protection Research
The head of the U.S. Food and Drug Administration is asking companies making sunscreen to conduct more research on the safety of products that protect against harmful sun rays.
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Trial Testing Gene-Edited, Modified Oilseed Plants
An agricultural science lab in the U.K. is beginning research on sustainable methods for growing genome-edited camelina plants, along with modifying the plant’s genetics by adding genes from other plant species.
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Cannabis Derivative Shown to Reduce Severe Seizures
A clinical trial shows treatments made with cannabidiol, a medical-grade derivative of cannabis plants, reduce the number of severe seizures in people with Lennox–Gastaut syndrome, when combined with conventional drugs.
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Crowdfunding Found Supporting Dubious Stem Cell Clinics
More people now use crowdfunding campaigns to raise money to cover families’ medical costs, but the technique is also used to support treatments from stem cell clinics that exaggerate their outcomes and minimize their risks.
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Trial Underway Testing Universal Flu Vaccine
A clinical trial is recruiting participants to test a vaccine to protect against a variety of influenza strains, instead of today’s vaccines designed to prevent infections from specific strains expected in a given year.