Cloud services have revolutionized the way businesses and governments operate, offering scalability, flexibility, cost-efficiency and security. This is especially the case in the life sciences industry, where the cloud has...more
On October 3rd, the Food and Drug Administration (FDA) published its widely anticipated proposed rule on the regulation of laboratory developed tests (LDTs). Last year, Congress failed to pass the Verifying Accurate,...more
On April 18, 2023, the U.S. Department of Health and Human Services (HHS) Office of the National Coordinator for Health Information Technology (ONC) published a far-reaching proposed rule, Health Data, Technology, and...more
Multiple policy documents relating to software and digital health have been issued by the U.S. Food and Drug Administration (FDA). The documents offer: a framework for the use of digital health tools in the context of drug...more
In recent days, the U.S. Food and Drug Administration (FDA) has issued multiple policy documents relating to software and digital health. Two of them relate to software-based medical devices: draft guidance for predetermined...more
On January 31, 2023, the U.S. Food and Drug Administration (FDA) announced a proposal to restructure the agency’s human foods program. FDA regulates almost 80 percent of the nation’s food supply and this work is a cornerstone...more
The U.S. Food and Drug Administration (FDA) announced the conclusion of an internal working group that cannabidiol (CBD) will require a new regulatory pathway. The FDA explicitly denied three citizen petitions urging the...more
In a break with past precedent, last year’s Food and Drug Administration (FDA) user fee reauthorization legislation did not contain significant FDA policy changes. Although the Senate Health, Education, Labor and Pensions...more
On September 30, 2022, Congress enacted legislation to reauthorize the Food and Drug Administration (FDA) user fee programs for branded/reference drugs and biologics, medical devices, generic drugs and biosimilars (PDUFA,...more
FDA Also Issues Report on Software Pre-Cert Pilot, Leaving Unanswered Questions on Future of Software Regulation -
Key Points -
The Final Guidance does not address the FDA’s risk-based enforcement discretion policy...more
Update on UFA Reauthorization Legislation -
As outlined in Akin Gump’s previous analysis, the current five-year authorization of the Food and Drug Administration (FDA) user fee programs for branded/reference drugs and...more
There continues to be no shortage of FDA-related issues in front of Congress this summer. In recent days, the pace of Congressional action on reauthorizing FDA’s user fee programs has significantly picked up with the Senate...more
On May 17 the Senate Health, Education, Labor and Pensions (HELP) Committee released a bipartisan legislative discussion draft of the Food and Drug Administration (FDA) Safety and Landmark Advancements Act (FDASLA), which...more
Last month, the Senate Health, Education, Labor and Pensions (HELP) Committee voted 20 to 2 to advance S. 3799, the Prepare for and Respond to Existing Viruses, Emerging New Threats and Pandemics Act (the “PREVENT Pandemics...more
Background on Cures 2.0 -
The COVID-19 pandemic response demonstrated the tremendous impact innovation can have on a global scale. The unprecedented experiences of the past year and a half have spurred renewed interest in...more
In vitro diagnostics (IVD) reform re-entered the legislative fray this week. The Verifying Accurate Leading-edge IVCT Development Act of 2021 (the “VALID Act of 2021,” the “VALID Act” or the “Act”) was introduced in both the...more
Key Points
- FDA will publish draft guidance on its Predetermined Change Control Plan in 2021 and host a public workshop on transparency requirements around AI/ML-based devices.
- FDA plans to pilot Real-World Performance...more
On August 6, President Trump issued an Executive Order (EO) titled “Ensuring Essential Medicines, Medical Countermeasures and Critical Inputs Are Made in the United States.” The far-reaching EO seeks to ensure the domestic...more
8/13/2020
/ Best Practices ,
Coronavirus/COVID-19 ,
Counterfeiting ,
Department of Defense (DOD) ,
Department of Health and Human Services (HHS) ,
Department of Homeland Security (DHS) ,
E-Commerce ,
Executive Orders ,
Exemptions ,
Food and Drug Administration (FDA) ,
Free Trade Agreements ,
Health and Safety ,
Imports ,
Infectious Diseases ,
Manufacturers ,
Medical Supplies ,
OMB ,
Personal Protective Equipment ,
Pharmaceutical Industry ,
Prescription Drugs ,
Procurement Guidelines ,
Public Health ,
Reporting Requirements ,
Section 301 ,
Supply Chain ,
Trump Administration ,
Waivers ,
WTO
Medical device and diagnostics companies and laboratories should anticipate significant legal, regulatory and market changes in 2020 that will have a lasting impact on the industry. From revisions to how the government...more
1/8/2020
/ Acquisitions ,
Artificial Intelligence ,
Biotechnology ,
Centers for Medicare & Medicaid Services (CMS) ,
CFIUS ,
Department of Health and Human Services (HHS) ,
Digital Health ,
EU ,
Export Controls ,
Food and Drug Administration (FDA) ,
General Data Protection Regulation (GDPR) ,
Health Insurance Portability and Accountability Act (HIPAA) ,
Innovation ,
Life Sciences ,
Machine Learning ,
Medical Devices ,
Mergers ,
Office of Foreign Assets Control (OFAC) ,
Patent-Eligible Subject Matter ,
Pharmaceutical Industry ,
Popular ,
Section 101 ,
USPTO
• FDA issues a Proposed Rule to allow states and other entities to import certain prescription drugs from Canada.
• In addition, FDA issues draft guidance for industry to explain how drug manufacturers can import their own...more
12/20/2019
/ Canada ,
Draft Guidance ,
Food and Drug Administration (FDA) ,
Imports ,
Manufacturers ,
Pharmaceutical Industry ,
Physicians ,
Prescription Drugs ,
Proposed Rules ,
Supply Chain ,
Trade Policy ,
Trump Administration
• 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 August 1, 2019, the U.S. District Court for the District of Columbia affirmed the U.S. Food and Drug Administration’s (FDA’s) decision to exclude the bulk drug substance vasopressin from the agency’s List of Bulk Drug...more
• In a recent warning letter, the Food and Drug Administration (FDA) advised a laboratory to seek marketing authorization for its genetic tests that qualified as laboratory developed tests (LDTs)—which have largely benefited...more
5/14/2019
/ Clinical Laboratories ,
Enforcement Actions ,
FDA Warning Letters ,
Food and Drug Administration (FDA) ,
Genetic Testing ,
Health Care Providers ,
Labeling ,
Laboratory Developed Tests ,
Life Sciences ,
Marketing ,
Medical Devices
Recent FDA Recall Highlights & Developments -
• The agency finalized Public Warning and Notification of Recalls Under 21 CFR Part 7, Subpart C; Guidance for Industry and FDA Staff, providing recommendations regarding the...more
4/11/2019
/ Centers for Disease Control and Prevention (CDC) ,
Distributors ,
Enforcement Actions ,
FDA Warning Letters ,
Food and Drug Administration (FDA) ,
Food Manufacturers ,
Food Recalls ,
Manufacturer Liability ,
Manufacturers ,
Medical Devices ,
Pharmaceutical Industry ,
Product Defects ,
Product Recalls
• FDA has released a white paper outlining a potential regulatory framework for software as a medical device (SaMD) that leverages artificial intelligence (AI) or machine learning (ML).
• The white paper distinguishes three...more