We use cookies to provide you with a better experience. By continuing to browse the site you are agreeing to our use of cookies in accordance with our Cookie Policy.
The FDA’s Center for Drug Evaluation and Research recommends in a new guidance that developers of antiviral drugs and biological products conduct nonclinical studies on a range of subjects before starting a Phase I clinical trial.
The FDA has issued an International Conference on Harmonisation guidance intended to enable pharmaceutical regulators and industry to make more effective and consistent risk-based decisions.
The FDA’s decision to withdraw seven guidances as inconsistent with its pharmaceutical current good manufacturing practices (cGMP) initiative is a sign that the agency is serious about updating its approach to cGMP and taking a more global view of regulations, industry sources say.
The FDA's decision to withdraw seven guidances as inconsistent with its pharmaceutical current good manufacturing practices (cGMP) initiative is a sign that the agency is serious about updating its approach to cGMP and taking a more global view of regulations, industry sources say.
The World Health Organization (WHO) has launched an effort with the lofty goal of registering every clinical trial -- including preliminary studies -- that tests treatments on patients or healthy volunteers globally.
The FDA is working on a guidance for multisite clinical trials where a coordinator other than the principal investigator (PI) performs the primary supervisory role.
The FDA, in a notice to be published in the Federal Register June 1, will announce its plans to withdraw and revise seven guidances as inconsistent with its pharmaceutical current good manufacturing practices (cGMP) initiative.
The FDA's Center for Devices and Radiological Health (CDRH) May 23 issued draft guidance on the use of Bayesian statistical methods in device clinical trials that could significantly shorten those trials.
The World Health Organization (WHO) has launched an effort with the lofty goal of registering every clinical trial -- including preliminary studies -- that tests treatments on patients or healthy volunteers globally.