Newsletter - January 26, 2023
FDA Guidance on Clinical Trials with Cannabis: Same Info, Repackaged?
This week’s FDA guidance on the conduct of clinical trials involving cannabis and its derivatives reminds the developers of two critical aspects of the regulation of such products by the FDA and confirms the associated regulatory processes. First, cannabis products containing greater that 0.3 percent delta-9 tetrahydrocannabinol (THC)...Read More
FDA Requirement for Clinical Trial Diversity Action Plans: Are They Useful?
Clinical trial sponsors are required to create and implement trial-specific “Race and Ethnicity Diversity Plan” for patient recruitment intended to promote diversity of the subject populations in all stages of their clinical trials. However, these plans have had limited impact on most clinical trials as shown by review of the...Read More
FDA Guidance on Clinical Trials with Cannabis: Same Info, Repackaged?
This week’s FDA guidance on the conduct of clinical trials involving cannabis and its derivatives reminds the developers of two critical aspects of the regulation of such products by the FDA and confirms the associated regulatory processes. First, cannabis products containing greater that 0.3 percent delta-9 tetrahydrocannabinol (THC)...Read More
FDA Requirement for Clinical Trial Diversity Action Plans: Are They Useful?
Clinical trial sponsors are required to create and implement trial-specific “Race and Ethnicity Diversity Plan” for patient recruitment intended to promote diversity of the subject populations in all stages of their clinical trials. However, these plans have had limited impact on most clinical trials as shown by review of the...Read More
