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The FDA is clarifying when drugmakers can seek dispute resolution above the divisional level, citing five regulatory actions that are appropriate for a formal dispute resolution request. Read More
The primary efficacy endpoint in clinical trials for uncomplicated gonorrhea should be a negative culture at the infection site three to seven days after receiving antibacterial drug therapy, the FDA says. Read More
Drugmakers are seeking clarification on the use of in vitro studies to assess the effects of active pharmaceutical ingredients taken by men on their potential offspring. Read More
A new study looking at large-scale clinical trials funded by NIH shows the number reporting positive results dropped precipitously in the years since they were required to preregister on the clinicaltrials.gov website. Read More
Drugmakers and patient groups are pressing the FDA for more leeway on approaches to developing drugs for Duchenne Muscular Dystrophy, saying a June draft guidance doesn’t go far enough. Read More
HHS on Sept. 2 proposed an overhaul of human research subject protections, including simpler informed consent forms, informed consent for secondary research using biospecimens and using a single IRB for all domestic sites in multisite clinical trials. Read More
A decline in spending on clinical research following implementation of the Physician Payment Sunshine Act could change the clinical trial landscape if it becomes an ongoing trend, an expert warns. Read More