Newsletter - March 3, 2022
Is There a Bi-Partisan Push for FDA To Regulate LDTs?
A group of Republican Congressmen wrote to FDA last month raising concerns about LDTs for prenatal genetic testing and as expected, FDA wrote back asking them to pass laws to regulate LDTs. FDA’s answer is a repeat of what it has said for the last decade or more, that it wants to regulate these diagnostic tests...Read More
FDA Releases Multiple Guidance Documents Specific to Cancer Clinical Trials
As promised, FDA released three new guidance documents specifically intended to help cancer drug development. These guidance documents cover common areas of concern in cancer clinical trials such as inclusion of older patients, concurrent recruitment of multiple cohorts to test the drug in multiple presentations...Read More
Is There a Bi-Partisan Push for FDA To Regulate LDTs?
A group of Republican Congressmen wrote to FDA last month raising concerns about LDTs for prenatal genetic testing and as expected, FDA wrote back asking them to pass laws to regulate LDTs. FDA’s answer is a repeat of what it has said for the last decade or more, that it wants to regulate these diagnostic tests...Read More
FDA Releases Multiple Guidance Documents Specific to Cancer Clinical Trials
As promised, FDA released three new guidance documents specifically intended to help cancer drug development. These guidance documents cover common areas of concern in cancer clinical trials such as inclusion of older patients, concurrent recruitment of multiple cohorts to test the drug in multiple presentations...Read More
