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Tag: FDA Guidance Documents

FDA Issues Guidance for Industry, “Statistical Considerations for Clinical Trials During the COVID-19 Public Health Emergency”

The FDA issued a guidance for industry entitled, “Statistical Considerations for Clinical Trials During the COVID-19 Public Health Emergency.” The COVID-19 pandemic has impacted clinical development and ongoing clinical trials across investigational product areas. Public health measures to control the virus may impact the ability to collect data, for example, if trial participants are not […]

FDA Guidance on Conduct of Clinical Trials of Medical Products during COVID-19 Pandemic

The U.S. Food and Drug Administration FDA today issued guidance for industry, investigators and institutional review boards conducting clinical trials during the coronavirus (COVID-19) pandemic. LINK: www.fda.gov/media/136238/download The FDA recognizes that the COVID-19 pandemic may impact the conduct of clinical trials of medical products, including drugs, devices and biological products.  Challenges may arise, for example, from quarantines, […]

Posted FDA Guidance Documents

10/24/2019 – Postmarketing Studies and Clinical Trials—Implementation of Section 505(o)(3) of the Federal Food, Drug, and Cosmetic Act Guidance for Industry This guidance provides information on the implementation of section 505(o)(3) of the Federal Food, Drug, and Cosmetic Act (the FD&C Act) (21 U.S.C. 355(o)(3)), which authorizes FDA to require certain postmarketing studies and clinical trials […]

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