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In its fifth annual drug shortage report to Congress, the FDA called 2017 “a challenging year” with shortages up again from 2016 despite a steady overall improvement since 2011. 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
“We were delighted to be one of the first companies to work with the PRIMA service, and collaborate with NICE on improving this valuable tool,” said Peter Wheatley-Price, Takeda UK’s market access and pricing director. Read More
In enrolling patients in prophylaxis trials, sponsors should ensure that patients have no detectable CMV infection post-transplantation within five days before the beginning of therapy. 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
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should use incidence of disease within 6 to 12 months post-transplantation as their primary endpoint, according to new draft guidance from the FDA.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