FDA issued a series of draft documents spelling out its processes for reviewing gene therapies for three types of diseases, as well as producing and testing these treatments. . . . → Read More: FDA Issues Draft Gene Therapy Regulatory Guidance
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A new report finds a large percentage of panel members that review drug applications for the Food and Drug Administration accept payments and other rewards from companies after their drugs are approved. . . . → Read More: FDA Reviewers Found Accepting Industry Payments After Drug Approvals 
A drug based on chemicals derived from cannabis plants was approved by Food and Drug Administration for marketing in the U.S. to treat seizures associated with two rare and severe forms of epilepsy. . . . → Read More: Cannabis Drug Approved by FDA for Rare, Severe Seizures  Comments are closed  Regulations  biomedical, clinical trials, Europe, FDA, life sciences, pharmaceuticals, U.K. 
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. . . . → Read More: FDA Issues Guidance on Patient Experience Data Collection Comments are closed Regulations biomedical, clinical trials, FDA, life sciences, medical device, pharmaceuticals, statistics 
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. . . . → Read More: FDA Delays Crispr Trial for Inherited Blood Diseases One comment - (Comments are closed) Regulations biomedical, biotechnology, clinical trials, Europe, FDA, genomics, licensing, life sciences, pharmaceuticals, stem cells 
A new formulation of a current drug to treat amyotrophic lateral sclerosis, or ALS, shows in its first clinical trial the drug produces more active ingredients against ALS than the current drug and causes no safety concerns. . . . → Read More: New ALS Drug Formula Shown Active, Safe Comments are closed New products biomedical, biotechnology, clinical trials, entrepreneurs, Europe, FDA, life sciences, pharmaceuticals 
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. . . . → Read More: FDA Okays A.I.-Guided Wrist Fracture Software Comments are closed New products, Regulations biomedical, engineering, equity, FDA, investment, life sciences, mathematics, medical device, physical sciences, software 
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. . . . → Read More: FDA Urges More Industry Sun Protection Research 
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. . . . → Read More: Cannabis Derivative Shown to Reduce Severe Seizures Comments are closed Regulations biomedical, clinical trials, Europe, FDA, life sciences, pharmaceuticals, U.K., university 
Two companies developing therapies for inherited blood disorders say the Food and Drug Administration approved their application to begin clinical trials of treatments for sickle cell disease with gene editing. . . . → Read More: Clinical Trials Okayed for Sickle Cell Gene Editing One comment - (Comments are closed) Joint ventures/collaborations, New products biomedical, biotechnology, clinical trials, FDA, life sciences, pharmaceuticals, stem cells |
One Blood Test Fits All Diseases A Thinking Person’s Artificial Intelligence Do You Want Your Bacon CRISPR? Health Care, Precisely One Person at a Time Let Guinea Pigs be Guinea Pigs Look Out Pharma. The Tech Industry is After You |
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