On May 16, 2024, the U.S. Drug Enforcement Administration (“DEA”) issued a Notice of Proposed Rulemaking (“NPRM”) to reclassify marijuana from Schedule I to Schedule III under the federal Controlled Substances Act (“CSA”) and...more
6/25/2024
/ Cannabis-Related Businesses (CRBs) ,
Controlled Substances Act ,
DEA ,
Department of Health and Human Services (HHS) ,
Federal Food Drug and Cosmetic Act (FFDCA) ,
Food and Drug Administration (FDA) ,
Law Enforcement ,
Marijuana ,
Motion To Reschedule ,
Notice of Proposed Rulemaking (NOPR) ,
Proposed Rules ,
Research Funding ,
Schedule I Drugs ,
Tax Deductions
On March 15, 2024, FDA published a white paper titled “Artificial Intelligence & Medical Products: How CBER, CDER, CDRH, and OCP are Working Together” (the AI White Paper) on the use of artificial intelligence (AI) across the...more
3/26/2024
/ Artificial Intelligence ,
CDRH ,
Center for Biological Diversity ,
Center for Biologics Evaluation and Research (CBER) ,
Center for Drug Evaluation and Research (CDER) ,
Department of Health and Human Services (HHS) ,
Food and Drug Administration (FDA) ,
Medical Devices ,
Popular ,
Public Health ,
Shareholders ,
White Papers
The Biden Administration recently announced a plan to leverage an old tool in a new way to try to reduce drug costs: exercising “march-in rights” under the Bayh-Dole Act for drugs that were supported by government funding. ...more
12/20/2023
/ Bayh-Dole Act ,
Biden Administration ,
Department of Health and Human Services (HHS) ,
Drug Pricing ,
Federal Contractors ,
Federal Trade Commission (FTC) ,
Inflation Reduction Act (IRA) ,
Innovation ,
Intellectual Property Protection ,
Inventions ,
Licenses ,
March-in-Rights ,
National Institute of Health (NIH) ,
NIST ,
Notice of Proposed Rulemaking (NOPR) ,
Orange Book ,
Pharmaceutical Patents ,
Prescription Drugs ,
Public Health Emergency ,
Research and Development
During the ongoing COVID-19 pandemic, the Center for Devices and Radiological Health (CDRH) in the U.S. Food and Drug Administration (FDA or the Agency) issued a series of Emergency Use Authorizations (EUAs) and guidance...more
The U.S. government has taken several steps in recent weeks to encourage companies to respond rapidly to the COVID-19 pandemic and resulting medical-supply shortage. As discussed here, to assuage concerns about potential...more