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
In the waning days of the Biden administration, the FDA released a flood of new guidance documents and other agency actions, including several important items related to digital health. On January 7, FDA published two new...more
1/31/2025
/ Artificial Intelligence ,
Biden Administration ,
Data Management ,
Digital Health ,
Food and Drug Administration (FDA) ,
Healthcare ,
Medical Devices ,
Pharmaceutical Industry ,
Regulatory Requirements ,
Risk Management ,
Transparency
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
In recent years, Congress and the U.S. Food and Drug Administration (“FDA”) have sought to reform the accelerated approval process, an expedited development and approval pathway for drugs that provide meaningful therapeutic...more
1/22/2025
/ Clinical Trials ,
Draft Guidance ,
Drug Safety ,
FDA Approval ,
Final Guidance ,
Food and Drug Administration (FDA) ,
Life Sciences ,
New Guidance ,
Pharmaceutical Industry ,
Prescription Drugs ,
Regulatory Reform ,
Regulatory Requirements
On January 7, 2025, FDA published a final guidance entitled Communications From Firms to Health Care Providers Regarding Scientific Information on Unapproved Uses of Approved/Cleared Medical Products - Questions and Answers...more
1/14/2025
/ Advertising ,
Compliance ,
Enforcement Actions ,
Final Rules ,
First Amendment ,
Food and Drug Administration (FDA) ,
Health Care Providers ,
Healthcare ,
Marketing ,
Medical Devices ,
Pharmaceutical Industry ,
Prescription Drugs ,
Regulatory Requirements
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 December 4, 2024, the U.S. Food and Drug Administration (“FDA”) released its final guidance for industry on predetermined change control plans (“PCCPs”) for devices that utilize artificial intelligence-enabled software...more
12/11/2024
/ Artificial Intelligence ,
Biden Administration ,
Digital Health ,
Executive Orders ,
Final Guidance ,
Food and Drug Administration (FDA) ,
Labeling ,
Life Sciences ,
Machine Learning ,
Medical Devices ,
Public Notice ,
Software
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