Caroline D. Kessler

Dec 10, 2024 | mondaq.com | Cheese Consumers |Anna K. Abram |Nathan Brown |Caroline D. Kessler

On December 5, 2024, FDA unveiled the draft guidance for industry regarding accelerated approval for drugs and biologics. This guidance provides additional information regarding the development of drugs and biologics to treat serious conditions for which there is an unmet need, and for which the sponsor is seeking accelerated approval.

Dec 6, 2024 | akingump.com | Anna K. Abram |Nathan Brown |Caroline D. Kessler

By: Anna K. Abram, Nathan A. Brown, Caroline D. KesslerOn December 5, 2024, FDA unveiled the draft guidance for industry regarding accelerated approval for drugs and biologics. This guidance provides additional information regarding the development of drugs and biologics to treat serious conditions for which there is an unmet need, and for which the sponsor is seeking accelerated approval.

Jun 3, 2024 | mondaq.com | Caroline D. Kessler |Craig B. Bleifer |Reggie Babin |Brian Daly

On May 16th, the U.S. Drug Enforcement Administration (DEA) issued a Notice of Proposed Rulemaking (NPRM) to initiate the rescheduling of marijuana from a Schedule I to a Schedule III drug.1The NPRM, which was published in the Federal Register on May 21st, is the first step of a formal rulemaking process required by the Controlled Substances Act (CSA) for rescheduling a controlled substance. This process, as detailed below, will likely include a public hearing before any final rule is published.

May 29, 2024 | akingump.com | Caroline D. Kessler |Craig B. Bleifer |Reggie Babin |Taylor Daly

On May 16th, the U.S. Drug Enforcement Administration (DEA) issued a Notice of Proposed Rulemaking (NPRM) to initiate the rescheduling of marijuana from a Schedule I to a Schedule III drug.1The NPRM, which was published in the Federal Register on May 21st, is the first step of a formal rulemaking process required by the Controlled Substances Act (CSA) for rescheduling a controlled substance. This process, as detailed below, will likely include a public hearing before any final rule is published.

Jan 12, 2024 | akingump.com | Caroline D. Kessler |Craig B. Bleifer |Reggie Babin |Taylor Daly

By: Caroline D. Kessler, Craig B. Bleifer, Reggie Babin, Taylor DalyKey PointsThe scientific review supporting HHS’s recommendation to DEA that cannabis be reclassified from a Schedule I to a Schedule III drug was published on January 12, 2024. Classifying cannabis as a Schedule III substance would have significant implications for state-legal cannabis businesses, including eliminating certain tax burdens for state-legal businesses and easing research restrictions.