On January 22, 2026, the National Institutes of Health (NIH) issued NOT-OD-26-028, prohibiting the use of NIH funds for research involving human fetal tissue (HFT) obtained from elective abortions (the Notice)....more
1/28/2026
/ Abortion ,
Biotechnology ,
Department of Health and Human Services (HHS) ,
Federal Funding ,
Grants ,
Human Embryos ,
Life Sciences ,
Medical Research ,
National Institute of Health (NIH) ,
New Guidance ,
Public Health ,
Regenerative Medicine ,
Regulatory Oversight ,
Reproductive Healthcare Issues ,
Research Funding ,
Scientific Research ,
Stem cells
On December 18, 2025, President Donald Trump signed an executive order that may breathe new life into efforts to move marijuana to a less restrictive schedule under the Controlled Substances Act (“CSA”)....more
1/14/2026
/ Cannabis Products ,
Cannabis-Related Businesses (CRBs) ,
Controlled Substances Act ,
DEA ,
Department of Health and Human Services (HHS) ,
Department of Justice (DOJ) ,
Executive Orders ,
Food and Drug Administration (FDA) ,
Hemp ,
Hemp Related Businesses ,
Marijuana ,
Medical Marijuana ,
Notice of Proposed Rulemaking (NOPR) ,
NPRM ,
Rulemaking Process ,
Trump Administration
On September 24, 2025, the National Institutes of Health (“NIH”) published a policy entitled “Enhancing Security Measures for Human Biospecimens” (the “Policy”). The Policy is based on Executive Order 14117, “Preventing...more
In a decision with significant legal and operational ramifications for organisations of all shapes and sizes, the Court of Justice of the European Union (CJEU) last week confirmed that pseudonymised data will not always and...more
9/9/2025
/ Court of Justice of the European Union (CJEU) ,
Data Controller ,
Data Privacy ,
Data Processing Rules ,
Data Protection ,
Data Protection Impact Assessments (DPIAs) ,
Data Transfers ,
EDPS ,
EU ,
European Court of Justice (ECJ) ,
General Data Protection Regulation (GDPR) ,
International Data Transfers ,
Personal Data ,
Regulatory Requirements ,
Transparency
On July 16, 2025, President Trump signed the Halt All Lethal Trafficking of Fentanyl (“HALT Fentanyl”) Act into law. The law permanently reclassifies “fentanyl-related substances” into Schedule I of the Controlled Substances...more
7/31/2025
/ Clinical Trials ,
Controlled Substances ,
Controlled Substances Act ,
DEA ,
Government Agencies ,
Medical Research ,
New Legislation ,
Pharmaceutical Industry ,
Regulatory Reform ,
Research and Development ,
Schedule I Drugs
On April 11, 2025, the Department of Justice (“DOJ”) released additional detail regarding the Final Rule implementing former President Biden’s Executive Order 14117, “Preventing Access to Americans’ Bulk Sensitive Personal...more
4/15/2025
/ China ,
Compliance ,
Corporate Counsel ,
Data Privacy ,
Department of Justice (DOJ) ,
Enforcement Actions ,
Executive Orders ,
Final Rules ,
New Guidance ,
Personal Data ,
Sensitive Personal Information
Today, the Department of Justice’s (“DOJ”) Final Rule implementing former President Biden’s Executive Order 14117, “Preventing Access to Americans’ Bulk Sensitive Personal Data and United States Government-Related Data by...more
On January 6, 2025, the U.S. Food and Drug Administration (“FDA”) and the Office for Human Research Protections (“OHRP”) issued a joint draft guidance on including tissue biopsies in clinical trials that evaluate...more
On January 8, 2025, the Department of Justice (“DOJ”) published its Final Rule to implement President Biden’s Executive Order 14117, “Preventing Access to Americans’ Bulk Sensitive Personal Data and United States...more
1/9/2025
/ Biometric Information ,
Broker-Dealer ,
CFIUS ,
Compliance ,
Cybersecurity ,
Cybersecurity Information Sharing Act (CISA) ,
Data Privacy ,
Data Protection ,
Data Security ,
Department of Justice (DOJ) ,
Enforcement ,
Executive Orders ,
Final Rules ,
Foreign Subsidiaries ,
Geolocation ,
Hong Kong ,
International Data Transfers ,
Life Sciences ,
Macau ,
National Security ,
PRC ,
Privacy Laws ,
Recordkeeping Requirements ,
Regulatory Requirements ,
Restricted Transactions ,
Risk Management ,
Sensitive Personal Information
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 this episode of Ropes & Gray’s podcast series Non-binding Guidance, health care partner David Peloquin and life sciences regulatory and compliance counsel Sarah Blankstein discuss the FDA's recent draft guidance on...more
On October 29, 2024, the Department of Justice (“DOJ”) published its Notice of Proposed Rulemaking (“NPRM”) to implement President Biden’s Executive Order 14117, “Preventing Access to Americans’ Bulk Sensitive Personal Data...more
11/5/2024
/ Biometric Information ,
CFIUS ,
China ,
Cybersecurity Information Sharing Act (CISA) ,
Data Brokers ,
Data Transfers ,
Department of Justice (DOJ) ,
Employment Contract ,
Executive Orders ,
Federal Food Drug and Cosmetic Act (FFDCA) ,
Financial Services Industry ,
Geolocation ,
Iran ,
National Security ,
North Korea ,
PRC ,
Prohibited Transactions ,
Proposed Rules ,
Recordkeeping Requirements ,
Risk Management ,
Russia ,
Sensitive Business Information