Food and Drug Administration recently warned GeneTech Inc. that its unauthorized stem cell regenerative medicine products, may be causing serious blood infections. . . . → Read More: FDA Warns Cord Blood-Stem Cell Company
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 2 comments - (Comments are closed)  Regulations  biomedical, FDA, health care, life sciences, pharmaceuticals, stem cells 
A law school professor urges developers, users, and regulators of machine learning in medicine to validate the algorithms that represent their underlying decision-making processes. . . . → Read More: Validation Scheme Proposed for Medical Algorithms Comments are closed Regulations biomedical, clinical trials, computer science, engineering, FDA, mathematics, medical device, physical sciences, software, university 
The Food and Drug Administration authorized a mobile app, when prescribed by clinicians for patients with opioid use disorder in outpatient treatment programs. . . . → Read More: FDA Clears Mobile App for Opioid Use Disorder One comment - (Comments are closed) Regulations behavioral science, biomedical, clinical trials, engineering, FDA, health care, life sciences, medical device, NIH, pharmaceuticals, software 
A report by a pharmaceutical industry organization says nearly 300 new therapies that transfer live cells or genes as treatments for disease are in clinical trials or being reviewed by Food and Drug Administration. . . . → Read More: Report – 289 Cell and Gene Therapies in Development One comment - (Comments are closed) Business conditions biomedical, biotechnology, cancer, clinical trials, FDA, genomics, heart disease, life sciences, pharmaceuticals 
The Food and Drug Administration identified a public database of genomics and diseases as a resource to assess new diagnostics tests using genetic data for precision medicine. . . . → Read More: FDA Identifies Database to Evaluate Precision Diagnostics 2 comments - (Comments are closed) Regulations biomedical, FDA, genomics, life sciences, NIH, pharmaceuticals 
The company developing a treatment for a rare inherited eye disease using the genome editing technique Crispr received authorization from the Food and Drug Administration to begin clinical trials. . . . → Read More: Trials OK’d for Inherited Eye Disease Therapy with Crispr 2 comments - (Comments are closed) New products biomedical, biotechnology, clinical trials, FDA, genomics, licensing, life sciences, pharmaceuticals 
The Food and Drug Administration yesterday approved a treatment for solid tumor cancers that focuses on specific cancer-causing genetic conditions rather than location of the cancer in the body. . . . → Read More: FDA Approves Biomarker-Targeting Cancer Drug 3 comments - (Comments are closed) New products, Regulations biomarkers, biomedical, biotechnology, cancer, clinical trials, FDA, genomics, life sciences, pharmaceuticals 
Final results from a clinical trial show a preventive treatment desensitizes children and adolescents with peanut allergies against reaction-causing proteins in peanuts for one year. . . . → Read More: Trial Shows Treatment Prevents Peanut Allergy Reactions Comments are closed New products, Regulations biomedical, biotechnology, clinical trials, Europe, FDA, life sciences, pharmaceuticals 
New data from a continuing survey of smoking among school-age children shows large increases in electronic cigarette use in high school and middle school children in just the past year. . . . → Read More: Survey Shows Sharp Rise in Teen E-Cigarette Use 
The Food and Drug Administration says it’s streamlining policies for making drugs and medical devices in clinical trials or under review available for people in the U.S. with life-threatening conditions. . . . → Read More: FDA Updating Expanded Access to Investigational Drugs, Devices One comment - (Comments are closed) Regulations biomedical, clinical trials, FDA, health care, medical device, pharmaceuticals |
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