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Navigating Uncertainty in US FDA’s Center for Devices and Radiological Health Regulation of Medical Devices

The past six months at the US Department of Health and Human Services and the US Food and Drug Administration’s Center for Devices and Radiological Health have seen a fluctuating workforce size, a slew of new executive...more

7/7/2025  /  Artificial Intelligence , Department of Health and Human Services (HHS) , Digital Health , Executive Orders , Food and Drug Administration (FDA) , Medical Devices , Regulatory Oversight , Regulatory Reform , Regulatory Requirements , Rulemaking Process

FDA Proposes New Tool for Post-Market Scientific Assessment of Food Ingredients

On June 18, 2025, FDA announced for public comment a Post-market Assessment Prioritization Tool (Prioritization Tool) as an enhanced systematic process for post-market scientific assessment of chemicals in food, including...more

6/30/2025  /  Food and Drug Administration (FDA) , Food Manufacturers , Food Safety , Public Comment , Regulatory Reform , Risk Assessment , Risk Management , Supply Chain , Toxic Chemicals

FDA Extends Scrutiny Over Color Additives Beyond Food to Drug Products

FDA’s recent focus on potentially harmful color additives in food products has expanded to the pharmaceutical sector. In May 2025, FDA issued a draft guidance titled Replacing Color Additives in Approved or Marketed Drug...more

6/6/2025  /  Comment Period , Draft Guidance , Food and Drug Administration (FDA) , Food Safety , New Guidance , Over The Counter Drugs (OTC) , Pharmaceutical Industry , Prescription Drugs , Regulatory Oversight , Regulatory Requirements

State Legislation on Color Additives in Food: Takeaways for Industry

Both state and federal government authorities have recently turned their attention toward artificial coloring in foods. The Food and Drug Administration (FDA) announced a series of measures in April 2025 to phase out all...more

5/15/2025  /  California , Food and Drug Administration (FDA) , Food Manufacturers , Food Safety , Manufacturers , New Legislation , Proposed Legislation , State Legislatures

Key Considerations for Foreign Clinical Trials When Looking Abroad for Product Development

With the continuing cuts to US Food and Drug Administration (FDA) staffing, the pharmaceutical and biotechnology industries are communicating increasing concern about potential product development impacts. While these cuts...more

4/2/2025  /  Clinical Trials , Data Privacy , Food and Drug Administration (FDA) , Imports , International Data Transfers , Pharmaceutical Industry , Pharmaceutical Patents , Regulatory Oversight , Regulatory Requirements , Supply Chain

The Future of Artificial Colors in the US Food Supply Is Not So Bright

Only weeks after being confirmed, the Department of Health and Human Services (HHS) secretary has advised food companies to remove artificial colors from their food products. He recently met with several major food brand...more

3/25/2025  /  Department of Health and Human Services (HHS) , Dietary Supplements , Enforcement Actions , Federal Food Drug and Cosmetic Act (FFDCA) , Food and Drug Administration (FDA) , Food Manufacturers , Food Safety , Public Health , Regulatory Agenda , Regulatory Requirements , State and Local Government

FDA’s Recent Guidance on Accelerated Approval and Implications for Rare Diseases

In honor of Rare Disease Day on February 28, 2025, we will publish a series of posts throughout the month on As Prescribed and Health Law Scan, focusing on issues impacting the rare disease community....more

3/3/2025  /  Federal Food Drug and Cosmetic Act (FFDCA) , Food and Drug Administration (FDA) , Health Care Providers , Life Sciences , New Guidance , Patient Access , Pharmaceutical Industry , Regulatory Reform , Regulatory Requirements

FDA’s Rare Disease Innovation Hub Releases Strategic Agenda: Implications for Stakeholders in 2025

In honor of Rare Disease Day on February 28, 2025, we will publish a series of posts throughout the month on As Prescribed and Health Law Scan, focusing on issues impacting the rare disease community....more

2/6/2025  /  Food and Drug Administration (FDA) , Innovation , Life Sciences , Medical Devices , Pharmaceutical Industry , Regulatory Agenda , Regulatory Requirements

How New Executive Orders May Affect FDA’s Medical Device Operations

Several executive orders recently signed by US President Donald Trump may have significant implications for the US Food and Drug Administration (FDA) and its regulatory oversight for medical device and digital health...more

2/3/2025  /  Artificial Intelligence , Digital Health , Executive Orders , Food and Drug Administration (FDA) , Medical Devices , Policy Updates , Regulatory Oversight , Regulatory Requirements , Trump Administration , World Health Organization

Clinicaltrials.gov: Recent Action May Signal Increased Attention from FDA on Trial Data Reporting Compliance

The US Food and Drug Administration (FDA) recently issued a notice of noncompliance to the FADOI Foundation, citing the organization’s failure to submit required clinical trial results to ClinicalTrials.gov. The notice...more

1/28/2025  /  Civil Monetary Penalty , Clinical Trials , Disclosure Requirements , Enforcement Actions , Food and Drug Administration (FDA) , Food and Drug Administration Amendments Act (FDAAA) , Reporting Requirements , Securities and Exchange Commission (SEC)
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