With the rapidly evolving regulatory landscape, staying on top of the latest updates is crucial for companies in biopharma and medical devices. In this briefing, we highlight recent regulatory and legislative developments...more
4/28/2025
/ Centers for Medicare & Medicaid Services (CMS) ,
Department of Health and Human Services (HHS) ,
Drug Pricing ,
Executive Orders ,
Food and Drug Administration (FDA) ,
Inflation Reduction Act (IRA) ,
Medical Devices ,
New Legislation ,
Prescription Drugs ,
Regulatory Reform ,
Tariffs
On March 31, 2025, in the U.S. District Court for the Eastern District of Texas vacated the Food and Drug Administration’s (FDA) final rule, in which FDA attempted to assert regulatory authority over laboratory-developed...more
On March 3, 2025, the U.S. Department of Health and Human Services (HHS) published a policy statement rescinding a decades-old administrative exemption for notice-and-comment rulemaking known as the Richardson Waiver. Written...more
3/7/2025
/ Department of Health and Human Services (HHS) ,
Food and Drug Administration (FDA) ,
Life Sciences ,
Medical Devices ,
Notice and Comment ,
Pharmaceutical Industry ,
Prescription Drugs ,
Public Health ,
Regulatory Authority ,
Regulatory Reform ,
Regulatory Requirements ,
Rulemaking Process
With the rapidly evolving regulatory landscape, staying on top of the latest updates is crucial for companies in biopharma and medical devices. In this briefing, we highlight recent regulatory and legislative developments...more
On January 7, 2025, the Food and Drug Administration (FDA) made available a draft guidance for industry (GFI) titled “Considerations for the Use of Artificial Intelligence to Support Regulatory Decision-Making for Drug and...more
On January 7, 2025, FDA published “Artificial Intelligence-Enabled Device Software Functions: Lifecycle Management and Marketing Submission Recommendations; Draft Guidance for Industry and Food and Drug Administration Staff”...more
With the rapidly evolving regulatory landscape, staying on top of the latest updates is crucial for companies in biopharma and medical devices. In this briefing, we highlight recent regulatory and legislative developments...more
On August 6, 2024, the Food and Drug Administration (FDA) partnered with the Clinical Trials Transformation Initiative (CTTI) to hold a joint, public workshop titled, “Artificial Intelligence (AI) in Drug & Biological Product...more
To help health and life science companies remain current on artificial intelligence-related legal and regulatory expectations, we have published many updates on the United States and European Union AI initiatives. Even when...more
The U.S. Food and Drug Administration is all about hard science, and correlation of variables is not evidence of causation. To make a regulatory decision, FDA has long held that line, requiring evidence of actual occurrences...more
A week before the EU’s AI Act comes into force on August 1, the White House announced that U.S. agencies have completed all actions required by President Biden’s AI Executive Order to date. Meanwhile, the Republican Party...more
It’s been a busy summer for the National Institute of Standards and Technology (NIST) and the U.S. AI Safety Institute (itself housed within NIST). July 26, 2024, marked the 270th day since President Biden issued his...more
On July 9, 2024, the Food and Drug Administrations (FDA) replaced a 10-year-old draft industry guidance on misinformation and social media information on prescription drugs and medical devices. The new guidance assists...more
The Drug Supply Chain Security Act (DSCSA) (Title 2 of the Drug Quality and Security Act, P.L. 113-54 (Nov 27, 2013)) amended Chapter V of the Federal Food, Drug, and Cosmetic Act (FD&C Act) by adding subchapter H —...more
Since President Biden issued his sweeping Executive Order on the Safe, Secure and Trustworthy Development of AI on October 30 of last year (EO), federal agencies have been operating in high gear to meet the deadlines and...more
On March 15, the United States Food & Drug Administration published a white paper entitled “Artificial Intelligence & Medical Products: How CBER, CDER, CDRH, and OCP are Working Together.” FDA announced the paper by sharing a...more
In December 2023, the Food and Drug Administration (FDA) issued a final guidance, “Verification Systems Under the Drug Supply Chain Security Act for Certain Prescription Drugs,” explaining the agency’s interpretation of the...more