On May 5, President Trump issued an Executive Order (EO) titled “Regulatory Relief to Promote Domestic Production of Critical Medicines,” with the stated purpose of eliminating “regulatory barriers to the domestic production...more
On March 31, 2025, Judge Sean D. Jordan of the U.S. District Court for the Eastern District of Texas issued an opinion and judgment in American Clinical Laboratory Association v. FDA. Judge Jordan’s decision vacates and sets...more
In the past week, the U.S. Food and Drug Administration (FDA), in collaboration with the Department of Health and Human Services (HHS) announced three new initiatives related to food safety and food supply chain transparency....more
3/25/2025
/ Comment Period ,
Compliance ,
Department of Health and Human Services (HHS) ,
Final Rules ,
Food and Drug Administration (FDA) ,
Food Safety ,
FSMA ,
Public Health ,
Regulatory Agenda ,
Regulatory Requirements ,
Supply Chain ,
Transparency
United States Department of Health and Human Services (HHS) Secretary Kennedy recently directed the U.S. Food and Drug Administration (FDA) to consider rulemaking to revise its longstanding regulations and guidance governing...more
Yesterday, the U.S. Food and Drug Administration (FDA) updated its website to provide new information on data integrity concerns relating to medical devices. Over a year ago, FDA’s device center, the Center for Devices and...more
In the final stretch of the Biden administration, the Food and Drug Administration (FDA) laid the groundwork for continued engagement with the public on two challenging areas of product development, each of which is of high...more
On January 6, 2025, the FDA released final guidance for industry entitled “Communications From Firms to Health Care Providers Regarding Scientific Information on Unapproved Uses of Approved/Cleared Medical Products: Questions...more
1/20/2025
/ Compliance ,
Final Guidance ,
Final Rules ,
Food and Drug Administration (FDA) ,
Health Care Providers ,
Healthcare ,
Medical Devices ,
OMB ,
Pharmaceutical Industry ,
Regulatory Agenda ,
Regulatory Reform ,
Regulatory Requirements
On January 7, the FDA made available draft guidance on the development of drugs and biological products for weight reduction within the Center for Drug Evaluation and Research intended for reduction and long-term maintenance...more
1/14/2025
/ Draft Guidance ,
Drug Pricing ,
Food and Drug Administration (FDA) ,
Health Care Providers ,
Healthcare ,
Life Sciences ,
New Guidance ,
Pharmaceutical Industry ,
Prescription Drugs ,
Public Health ,
Regulatory Requirements
Welcome to the March edition of Akin Intelligence. This month, the EU AI Act was approved by the European Parliament, moving one step closer to becoming the first major AI law. In the U.S., the DOJ brought criminal charges...more
4/10/2024
/ Artificial Intelligence ,
Biden Administration ,
Commercial Litigation ,
Copyright ,
Corporate Governance ,
Cybersecurity ,
Data Privacy ,
Data Security ,
EU ,
Executive Orders ,
Healthcare ,
Innovative Technology ,
Intellectual Property Protection ,
Legislative Agendas ,
Life Sciences ,
Machine Learning ,
National Security ,
Regulatory Agenda ,
Regulatory Reform ,
Regulatory Requirements ,
State and Local Government ,
Technology Sector ,
UK
2024 is shaping up to be a busy year in Washington for telecom, media and technology (TMT) companies. A number of notable topics will require public comment this year, including net neutrality, digital discrimination, data...more
2/9/2024
/ Artificial Intelligence ,
Broadband ,
Consumer Protection Laws ,
FCC ,
Federal Aviation Administration (FAA) ,
NDAA ,
Outer Space ,
Public Comment ,
Regulatory Requirements ,
Spectrum ,
Technology Sector ,
Telecommunications
• The FDA recently issued six guidance documents that further clarify the agency’s interpretation of the 21st Century Cures Act’s software exemptions.
• The revised draft guidance on CDS further elaborates on how to make CDS...more
10/8/2019
/ 21st Century Cures Act ,
CDS ,
Comment Period ,
Digital Health ,
Draft Guidance ,
Food and Drug Administration (FDA) ,
Health Care Providers ,
International Medical Device Regulators Forum (IMDRF) ,
Medical Devices ,
Medical Software ,
Patients ,
Popular ,
Public Comment ,
Regulatory Requirements ,
Software Developers
On April 11, 2019, acting director of the Office of Management and Budget (OMB) Russell Vought announced a policy for review of federal agency rules and guidance that represents a significant change of process for issuance of...more
• Two new draft guidances aim to conform FDA’s existing digital health-related policies to the software exemptions from the device definition added by Cures, and are largely faithful to those legislative provisions.
• The...more
1/3/2018
/ 21st Century Cures Act ,
Center for Drug Evaluation and Research (CDER) ,
Digital Health ,
Draft Guidance ,
Federal Food Drug and Cosmetic Act (FFDCA) ,
Food and Drug Administration (FDA) ,
Health Care Providers ,
Medical Device User Fee Program (MDUFA IV) ,
Medical Devices ,
Medical Software ,
Regulatory Requirements ,
Software Developers ,
Technology Sector