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The FDA published a new draft guidance on the scientific and ethical considerations for including pregnant women in clinical trials, telling sponsors that data are needed to inform safe and effective treatment during pregnancy, and that it is appropriate to enroll pregnant women in certain situations. Read More
The FDA adopted an addendum updating the ICH’s E11 guideline on pediatric clinical trials, outlining ethical considerations, age classifications, pediatric drug formulations, practicalities in clinical trials and approaches to optimizing drug development. Read More
Rep. Frank Pallone (D-N.J.) proposed new legislation on continuous manufacturing during a joint visit with FDA Commissioner Scott Gottlieb to Rutgers University on Monday to discuss the campus’ role in advancing the technology. Read More
The FDA adopted an addendum updating the ICH’s E11 guideline on pediatric clinical trials, outlining ethical considerations, age classifications, pediatric drug formulations, practicalities in clinical trials and approaches to optimizing drug development. Read More
The draft guidance recommends sponsors initiate pediatric studies early in development, typically after obtaining initial evidence from early-phase adult studies. Read More
The FDA published a new draft guidance outlining how early sponsors should incorporate pediatric patients, and the relevant age groups, for systemic therapies for atopic dermatitis. Read More
The FDA published a new draft guidance on the scientific and ethical considerations for including pregnant women in clinical trials, telling sponsors that data are needed to inform safe and effective treatment during pregnancy, and that it is appropriate to enroll pregnant women in certain situations. Read More
For vaccines that target a second type B strain in addition to the other three strains, a B/Phuket/3073/2013-like virus is considered appropriate, EMA said. Read More
The FDA released five guidances on treatments for a variety of neurological disorders including Duchenne muscular dystrophy and Alzheimer’s disease, offering suggestions for trial designs and methods of measuring effectiveness. Read More
Such a framework would “inform negotiations between drug manufacturers and payers and… could guide development of value-based payment models,” the panel said. Read More