Claire Castles

Claire Castles

Jones Day

Contact
View Bio
RSS

Latest Posts › Food and Drug Administration (FDA)

Share:

CMS's New TCET Pathway Expedites Medicare Coverage for FDA Breakthrough Devices

The Centers for Medicare and Medicaid Services ("CMS") published a final notice outlining the processes and procedures for the Transitional Coverage for Emerging Technologies ("TCET") pathway, a Medicare coverage pathway...more

1/30/2025  /  Centers for Medicare & Medicaid Services (CMS) , Final Rules , Food and Drug Administration (FDA) , Healthcare , Life Sciences , Medical Devices , Medicare , Pharmaceutical Industry , Regulatory Agenda , Regulatory Reform

FDA Announces Proposed Rule Regarding Laboratory Developed Tests

The highly anticipated rule, which would make explicit that LDTs are medical devices subject to FDA oversight, proposes to end the agency's general enforcement discretion approach to such devices....more

10/31/2023  /  Comment Period , FDA Approval , Food and Drug Act , Food and Drug Administration (FDA) , Healthcare , Laboratory Developed Tests , Life Sciences , Manufacturers , Medical Devices , Pharmaceutical Industry , Proposed Rules , Regulatory Agenda , Regulatory Reform

California Becomes the First State to Ban Four Common Food Additives

With the swipe of a pen, California Governor Gavin Newsom starts the California Food Safety Act countdown to a 2027 statewide ban on four popular food additives. Starting January 1, 2027, companies manufacturing, selling,...more

10/20/2023  /  Additive Manufacturing , California , Dietary Supplements , Food & Drug Regulations , Food and Drug Administration (FDA) , Food Labeling , Food Manufacturers , Food Products . , Food Safety , New Legislation , Public Health , Regulatory Reform , State Bans

Industry Anticipates Impending FDA Proposed Regulation Addressing Laboratory Developed Tests

Stakeholders prepare for the U.S. Food and Drug Administration's ("FDA") rulemaking effort to "make explicit" that laboratory developed tests ("LDTs") are devices subject to the agency's oversight, reigniting outstanding...more

8/31/2023  /  Clinical Laboratory Testing , Coronavirus/COVID-19 , Department of Health and Human Services (HHS) , Draft Guidance , Federal Food Drug and Cosmetic Act (FFDCA) , Food and Drug Administration (FDA) , Medical Devices , OIRA , Proposed Regulation , Proposed Rules

Clarifying Cosmetics Reform: FDA Issues Draft Guidance on Registration and Product Listings

Heralding the significant changes coming to the U.S. cosmetics industry starting in 2023, the U.S. Food and Drug Administration ("FDA") has issued draft guidance to companies regarding cosmetic facility registrations and...more

8/23/2023  /  Comment Period , Cosmetics , Draft Guidance , Food and Drug Administration (FDA) , Listing Rules , Manufacturers , Modernization of Cosmetics Regulation Act of 2022 (MoCRA) , Product Identifiers , Product Labels , Product Packaging , Registration Requirement

Vital Signs Digital Health Law Update | Spring 2023

Note From the Editors - This edition of Vital Signs is filled with digital health developments from around the world. In Industry Insights, you'll see and hear from Alexis Gilroy and Claire Castles, each in a short video...more

5/15/2023  /  Clinical Trials , Data Collection , DEA , Department of Health and Human Services (HHS) , Digital Health , Food and Drug Administration (FDA) , Health Care Providers , OIG , Popular , Substance Abuse , Telehealth

FDA Takes Long-Awaited Action on Labeling Plant-Based Milk Alternatives

Following several years of lead-up, including public engagement, the review of more than 13,000 comments, and conducting focus group studies, on February 22, 2023, the U.S. Food and Drug Administration ("FDA") issued a draft...more

3/3/2023  /  Draft Guidance , Food and Drug Administration (FDA) , Food Labeling , Labeling , Plant Based Products , Product Labels

FDA Announces Overhaul of Human Foods Program

On January 31, 2023, the Food and Drug Administration ("FDA") announced plans to redesign its Human Foods Program (the "Program") to better coordinate the agency's regulation of food products....more

3/1/2023  /  Dietary Supplements , Food and Drug Administration (FDA) , Food Safety , Food Supply

Senate Judiciary Committee Revisits Drug Pricing Reform Bills

The Senate Judiciary Committee is showing renewed Congressional interest in oversight of the pharmaceutical industry, with five bipartisan drug bills on the agenda for review and discussion on February 9, 2023....more

2/13/2023  /  Drug Pricing , Food and Drug Administration (FDA) , Pharmaceutical Industry , Popular , Prescription Drugs

Food, Drugs, Cosmetics, and Devices: Federal Regulatory Focus Areas in 2023

In Short - The Situation: With the calendar officially turned to a new year several significant changes and regulatory initiatives are on the horizon at the Food and Drug Administration ("FDA")....more

1/23/2023  /  Cosmetics , Federal Trade Commission (FTC) , Food & Drug Regulations , Food and Drug Administration (FDA) , Medical Devices , Popular , Regulatory Agenda , Regulatory Requirements , USPTO

FDA Submits Final Food Traceability Rule in Effort to Mitigate Foodborne Illness Outbreaks

On November 7, 2022, the U.S. Food and Drug Administration ("FDA") sent the Food Safety Modernization Act ("FSMA") Final Rule on Requirements for Additional Traceability Records for Certain Foods to the Office of the Federal...more

11/16/2022  /  Final Rules , Food and Drug Administration (FDA) , Food Borne Bacteria , Food Manufacturers , Food Safety , FSMA

The Complex Labeling Landscape for Plant-Based Meat Alternatives

With the rise of plant-based alternatives to conventional meat products, the industry has come under scrutiny from government regulators, both in the United States and abroad. In 2019 alone, nearly 30 states considered...more

1/3/2020  /  False Advertising , Food and Drug Administration (FDA) , Food Labeling , Food Manufacturers , Food Supply , Legislative Agendas , Misleading Impressions , Plant Based Products , Regulatory Oversight , Regulatory Standards

Consumer Groups File Petition Urging the USDA to Change Meat Labeling Requirements

For years, natural sources of nitrates and nitrites have been used to cure meats as an alternative to traditional synthetic sources. The United States Department of Agriculture ("USDA") requires companies that cure meats...more

12/30/2019  /  Citizen Petitions , Comment Period , Consumer Confusion , Consumer Reports , Department of Agriculture , False Advertising , Food and Drug Administration (FDA) , Food Labeling , Product Labels , Public Interest , Regulatory Agenda , Unfair or Deceptive Trade Practices , USDA
13 Results
 / 
View per page
Page: of 1

"My best business intelligence, in one easy email…"

Your first step to building a free, personalized, morning email brief covering pertinent authors and topics on JD Supra:
Sign up Log in
*By using the service, you signify your acceptance of JD Supra's Privacy Policy.
- hide
- hide