On this episode of Ropes & Gray’s podcast series Controlling Opinions, life sciences regulatory and compliance partner Josh Oyster and counsel Beth Weinman are joined by health care partner Brett Friedman and litigation and...more
2/11/2025
/ Cannabis Products ,
Controlled Substances ,
Controlled Substances Act ,
DEA ,
Decriminalization of Marijuana ,
Department of Justice (DOJ) ,
Enforcement Actions ,
Health Care Providers ,
Life Sciences ,
Prescription Drugs ,
Regulatory Agenda ,
Telemedicine ,
Trump Administration
The U.S. Food and Drug Administration (“FDA”), in partnership with the Department of Justice (“DOJ”), pursued significant and, in some cases, precedent-setting enforcement actions in 2024. The government continued to...more
1/22/2025
/ Administrative Procedure Act ,
Consent Decrees ,
Constitutional Challenges ,
Corporate Integrity Agreement ,
Deferred Prosecution Agreements ,
Department of Justice (DOJ) ,
Enforcement Actions ,
False Claims Act (FCA) ,
Federal Food Drug and Cosmetic Act (FFDCA) ,
Food and Drug Administration (FDA) ,
Food Safety ,
Life Sciences ,
Medical Devices ,
Opioid ,
OxyContin ,
Pharmaceutical Industry ,
Prescription Drugs ,
Public Health ,
Purdue Pharma ,
Qui Tam ,
Regulatory Requirements ,
Stem cells ,
Transparency
As the curtain closed on 2024, FDA issued a new draft guidance to assist clinical trial sponsors, investigators, and institutional review boards (“IRBs”) with defining, identifying, and reporting protocol deviations in...more
1/7/2025
/ Classification ,
Clinical Trials ,
Comment Period ,
Department of Health and Human Services (HHS) ,
Draft Guidance ,
Food and Drug Administration (FDA) ,
Good Clinical Practices ,
Institutional Review Board (IRB) ,
International Harmonization ,
Investigations ,
Life Sciences ,
Medical Devices ,
Medical Research ,
Office for Human Research Protections (OHRP) ,
Prescription Drugs ,
SACHRP
On September 27, 2024, the U.S. Court of Appeals for the Ninth Circuit reversed the district court’s decision in U.S. v. California Stem Cell Treatment Center, Inc. (“California Stem Cell”), holding that a clinic’s stem cell...more
12/10/2024
/ Chevron Deference ,
Federal Food Drug and Cosmetic Act (FFDCA) ,
Federal Trade Commission (FTC) ,
Food and Drug Administration (FDA) ,
Health Clinics ,
Life Sciences ,
Loper Bright Enterprises v Raimondo ,
PHSA ,
Regenerative Medicine ,
Regulatory Oversight ,
Statutory Interpretation
On this episode of Ropes & Gray’s podcast series Controlling Opinions, Josh Oyster, a partner in the life sciences regulatory and compliance practice group, is joined by colleagues Andrew O’Connor, a litigation and...more