Newsletter - April 12, 2018
FDA Redefines Expectations for Clinical Trials in Children and Pregnant Women
Two new FDA guidance documents discuss the practical and regulatory aspects of testing new products in children and pregnant women confirming the well-established industry practices for these populations. Both documents emphasize the need to test new drugs in children and pregnant women only when absolutely...Read More
FDA Expands Abbreviated 510k Process for Moderate Risk Devices
FDA plans to accept 510k applications for medical devices that show compliance with FDA defined standards rather than direct comparison to the predicate device by expanding its abbreviated 510k program under the least burdensome philosophy. FDA will release a list of 510k devices that could use this new program...Read More
FDA Redefines Expectations for Clinical Trials in Children and Pregnant Women
Two new FDA guidance documents discuss the practical and regulatory aspects of testing new products in children and pregnant women confirming the well-established industry practices for these populations. Both documents emphasize the need to test new drugs in children and pregnant women only when absolutely...Read More
FDA Expands Abbreviated 510k Process for Moderate Risk Devices
FDA plans to accept 510k applications for medical devices that show compliance with FDA defined standards rather than direct comparison to the predicate device by expanding its abbreviated 510k program under the least burdensome philosophy. FDA will release a list of 510k devices that could use this new program...Read More
