In 2025, Life Sciences and Health Care (LS&HC) companies face rapidly evolving regulatory paradigms that create transactional risks and require daily monitoring. After more than 70 national elections in 2024, the dust hasn’t...more
8/25/2025
/ Artificial Intelligence ,
Clinical Trials ,
Cybersecurity ,
Digital Health ,
Environmental Social & Governance (ESG) ,
Genetic Materials ,
Government Agencies ,
Healthcare ,
Healthcare Reform ,
Innovative Technology ,
Life Sciences ,
Pharmaceutical Industry ,
Public Health ,
Regulatory Oversight ,
Regulatory Reform ,
Regulatory Requirements ,
Risk Management ,
Supply Chain ,
Trump Administration
The U.S. Food and Drug Administration (FDA) published a revision of its final guidance on “Application User Fees for Combination Products,” replacing guidance of the same name from 2005. The revision modernizes the guidance...more
The U.S. Food and Drug Administration (FDA) issued the revised draft guidance, “Addressing Misinformation About Medical Devices and Prescription Drugs,” which clarifies how firms can address misinformation about their...more
The U.S. Food and Drug Administration (FDA) announced yesterday a “Small Entity Compliance Guide” (SECG) for Laboratory Developed Tests (LDTs), aiming to assist small entities in complying with FDA’s LDT final rule, which...more
The U.S. Food and Drug Administration (FDA) has finalized its guidance on “Remanufacturing of Medical Devices,” clarifying the point when manipulation or repair of a medical device becomes “remanufacturing” as opposed to...more
The U.S. Food and Drug Administration (FDA) has finalized its historic — and notoriously controversial — rule to explicitly assert the agency’s authority to regulate laboratory developed tests (LDTs). Below we summarize the...more
On Tuesday, the U.S. Food and Drug Administration (FDA) issued a letter warning medical device manufacturers and sponsors of device studies to carefully evaluate the third parties that they engage to conduct performance...more
Last week, the U.S. Food and Drug Administration (FDA) proposed two new rules for classification of certain, previously unclassified wound dressings and liquid wound washes containing antimicrobials, which would categorize...more
The U.S. Food and Drug Administration (FDA) published new draft guidance on “Regulatory Considerations for Prescription Drug Use-Related Software” (PDS Guidance), which describes how FDA intends to apply its drug labeling...more
In a landmark proposed rule published Friday, the U.S. Food and Drug Administration (FDA) announced plans to make explicit that in vitro diagnostic products (IVDs), including in cases where the manufacturer of the IVD is a...more
The U.S. Food and Drug Administration (FDA) published an updated final guidance on the use of International Standard ISO 10993-1, “Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk...more
While devices that stimulate the brain invasively have generally been available since 2002, and devices that do so non-invasively have been available since 2013, in recent years, the U.S. Food and Drug Administration (FDA)...more
The U.S. Food and Drug Administration recently released the guidance “Oncology Drug Products Used with Certain In Vitro Diagnostic Tests: Pilot Program,” laying out the process by which FDA will offer up to nine drug makers...more
The U.S. Food and Drug Administration (FDA) has finalized its guidance “Electronic Submission Template for Medical Device 510(k) Submissions,” which will require medical device 510(k) submissions to use FDA’s electronic...more
On July 25, 2022, the U.S. Food and Drug Administration (FDA) issued final guidance on Unique Device Identification (UDI) compliance date policies, stating that the agency will not enforce a requirement that manufacturers of...more
The COVID-19 Report is a compilation of coronavirus news, analysis, and insights from around the world to help life sciences and health care companies stay current in this challenging time. In this week's Report: Woodcock...more
The COVID-19 Report is a compilation of coronavirus news, analysis, and insights from around the world to help life sciences and health care companies stay current in this challenging time. In this week's Report: FDA issues...more
The COVID-19 Report is a compilation of coronavirus news, analysis, and insights from around the world to help life sciences and health care companies stay current in this challenging time. In this week's Report: U.S....more
On August 9, the U.S. Food and Drug Administration (FDA) published a notice announcing its implementation of the U.S. Court of Appeals for the D.C. Circuit’s April 2021 decision in Genus Medical Technologies LLC v. U.S. Food...more
8/13/2021
/ Biotechnology ,
Drug Approvals ,
Drug Compounding ,
FDA Approval ,
Federal Food Drug and Cosmetic Act (FFDCA) ,
Food and Drug Administration (FDA) ,
Genus ,
Life Sciences ,
Manufacturers ,
Medical Devices ,
Pharmaceutical Industry ,
Public Comment
The COVID-19 Report is a compilation of coronavirus news, analysis, and insights from around the world to help life sciences and health care companies stay current in this challenging time. In Wednesday's Report: U.S....more
The U.S. Court of Appeals for the D.C. Circuit recently decided in Genus Medical Technologies LLC v. U.S. Food and Drug Administration that, when classifying a biomedical product as either a “drug” or a “device,” FDA does not...more
In Tuesday's Report: FDA warns of false test results due to mutations, and authorizes new OTC tests; NY state clarifies paid vaccination leave law; and California requires COVID-19 paid sick…...more
4/6/2021
/ Coronavirus/COVID-19 ,
Employee Rights ,
Food and Drug Administration (FDA) ,
Infectious Diseases ,
Life Sciences ,
New Legislation ,
Paid Sick Leave ,
Paid Time Off (PTO) ,
Pharmaceutical Industry ,
Vaccinations ,
Virus Testing
Companies in the life sciences and health care industry, like most companies, navigated unparalleled challenges in 2020. But unlike other industries, they had to do so while simultaneously facing the biggest challenge of all...more
On January 6, 2021, the U.S. Food and Drug Administration (FDA) published a final guidance outlining the Safer Technologies Program (STeP) for Medical Devices: a voluntary program for medical devices and device-led...more
The U.S. Food and Drug Administration (FDA) recently finalized its guidance entitled “Requesting Food and Drug Administration Feedback on Combination Products,” stressing as it did in the draft version that “application-based...more