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Keeping you afloat amidst the rising sea of regulations

DEA Denies Marijuana Rescheduling Petition, Eases Research Restrictions

DEA will not reschedule marijuana unless the FDA determines the drug has a medical use. DEA’s new research policy will hopefully facilitate future necessary medical research. Ending months of speculation, the Drug Enforcement Administration announced yesterday that it declined to down-classify marijuana f

Legislation Introduced in Congress to Ease Medical Marijuana Restrictions

Last week, bipartisan legislation was introduced in the US Senate and the House of Representatives to amend the Controlled Substances Act and ease federal obstacles for medical researchers to conduct clinical studies on the medical benefits of marijuana.

Wait Just a Minute: Department of Health and Human Services Releases Draft Guidance on Preparing IRB Meeting Minutes

Federal regulations require institutions and institutional review boards (IRB) that are responsible for review and oversight of human subject research to prepare and maintain adequate documentation of IRB activities, including minutes of IRB meetings. On November 5, 2015, the Department of Health and Human Services (HHS) Office for Human Research Protections (OHRP) and the Food and Drug Administration (FDA) announced the availability of draft guidance regarding IRB minutes (Draft Guidance). (See 80 Fed. Reg.