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The European Medicines Agency issued a report card on the first two years of its Priority Medicines (PRIME) Scheme, highlighting that it has received and processed 177 requests for eligibility for the program that provides early scientific and regulatory support for medicines based on promising preliminary clinical evidence. Read More

Sponsors of trials for drugs to prevent cytomegalovirus (CMV) infection in transplantation should use incidence of disease within 6 to 12 months post-transplantation as their primary endpoint, according to new draft guidance from the FDA. Read More

The FDA finalized guidance outlining clinical trial designs for hypogonadotropic hypogonadism treatments, recommending efficacy endpoints and enrollment criteria. Read More

The increased use of fast track regulatory pathways has led to the FDA having the shortest median approval time for new active drug substances in 2017 compared to five other international regulatory agencies, according to the UK-based Centre for Innovation in Regulatory Science (CIRS). 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 to discuss the campus’ role in advancing the technology. Read More

The European Medicines Agency issued a report card on the first two years of its Priority Medicines (PRIME) Scheme, highlighting that it has received and processed 177 requests for eligibility for the program that provides early scientific and regulatory support for medicines based on promising preliminary clinical evidence. 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The FDA published a new draft guidance on the scientific and ethical considerations for including pregnant women in clinical trials, telling sponsors that data are needed to inform safe and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

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