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Clinical investigators are increasingly turning to industry sponsors to help them cover “hidden” trial costs — such as prestudy services — that are starting to eat away at research institutions’ operating budgets.
Manufacturers should attempt to identify differences in drug metabolism between animals used in nonclinical safety assessments and humans as early as possible during the drug development process to ensure timely assessment of potential safety issues, the FDA recommends in a draft guidance.
Drugmakers should be prepared to justify their decisions not to follow specific recommendations in the FDA’s recent guidances on minimizing drug-safety risks, say experts, who warn the nonbinding suggestions could be used against firms in court.
Recent criticism from the medical journal community, which accused drugmakers of withholding information from online public trial registries, is unfounded and unfair, according to a pair of large pharmaceutical firms that said they are doing everything in their power to improve transparency and accessibility.
Pharmaceutical firms developing antiviral drugs should conduct nonclinical studies of the product candidates before initiating Phase I clinical trials, according to an FDA draft guidance.
Drugmakers should conduct nonclinical studies of antiviral drug candidates before initiating Phase I clinical trials, according to an FDA draft guidance.
Clinical trial data submitted to online registries must contain useful and complete information for the study to be eligible for publication, according to the International Committee of Medical Journal Editors (ICMJE), which accused some manufacturers of providing incomplete data sets.
The FDA recently released an updated guidance concerning industry documentation in support of software submissions as part of the agency's ongoing efforts to revise its guidelines to enhance their clarity and timeliness regarding emerging technologies.