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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The FDA published draft guidance to assist developers of monotherapeutic, combination and adjunctive drug treatments for major depressive disorder (MDD), offering considerations for nonclinical safety and clinical pharmacology. Read More

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

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should use incidence of disease within 6 to 12 months post-transplantation as their primary endpoint, according to new draft guidance from the FDA.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