Regulatory Standards, Food and Drug Administration (FDA), Labeling

FDA and USDA Seek Comments on Standardizing Food Date Labeling

Perkins Coie on 12/16/2024

The U.S. Department of Agriculture’s (USDA) Food Safety and Inspection Service (FSIS) and the U.S. Food and Drug Administration (FDA) recently published a joint Request for Information (RFI) seeking stakeholder input related...more

Inside the Healthcare Industry: The Impact of Human Factors & User Experience in Healthcare

J.S. Held on 10/7/2024

Human Factors and User Experience testing play an important role in healthcare settings and in the development of healthcare products. They can greatly impact the delivery of care, and the patient experience delivered by...more

FDA Issues Revised Draft Guidance on “Scientific Information on Unapproved Uses Communications”

Foley Hoag LLP on 10/25/2023

On October 23, 2023, FDA published a draft guidance document to provide detailed recommendations to industry regarding the communication of unapproved uses of approved or cleared drugs and medical devices to health care...more

FDA Solicits Feedback to Create Consistent Process for Labeling Devices

Faegre Drinker Biddle & Reath LLP on 6/11/2021

The Food and Drug Administration Center for Devices and Radiological Health is soliciting feedback on how materials information about medical devices should be communicated to patients and healthcare providers. On May 20,...more

FDA Proposes a New Risk-Based Enforcement Approach for Certain Categories of Homeopathic Drug Products

Kilpatrick on 12/27/2017

More than 2 years after the Food and Drug Administration (FDA or agency) held a public hearing to obtain input from both the public and industry stakeholders regarding its current regulatory framework for homeopathic drug...more

FDA Pushes UDI System Compliance Date Back for Class I and Unclassified Devices

Hogan Lovells on 6/12/2017

On June 2, 2017, the U.S. Food and Drug Administration (FDA) announced in a letter to device labelers that it will issue a guidance document stating that FDA will exercise its enforcement discretion for the unique device...more

FTC Staff Comment Encourages FDA to Reevaluate its Current Approach to Regulating Homeopathic Products

Kelley Drye & Warren LLP on 8/25/2015

On Friday, staff of the Federal Trade Commission’s Bureau of Consumer Protection, Office of Policy Planning, and Bureau of Economics submitted a written comment to FDA recommending that FDA reconsider its current regulatory...more

Regulatory Standards › Food and Drug Administration (FDA) › Labeling