Category Archives: DHHS

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HHS Removes Extra Hurdle for Marijuana Research

The process for studying the potential medical benefits of marijuana became more streamlined on Tuesday, when the U.S. Department of Health and Human Services eliminated a controversial requirement for Public Health Service review of non-federally funded research protocols involving marijuana. Historically, in addition to the standard FDA and Drug Enforcement Administration approvals needed for research … Continue Reading

DHHS and FDA Officials Respond to Medical Device Mobile Application Regulatory Concerns on Final Day of Hearings

The House Subcommittee on Oversight and Investigations concluded a three-day series of hearings regarding medical device mobile applications (“MMAs”) on Thursday morning. Our posts regarding the first two hearings are here and here. The focus of day three was to hear testimony from key FDA and DHHS officials who have responsibilities relating to MMAs and … Continue Reading

Heightened FDA Activity Related to OTC Drugs Expected in 2013

According to the 2013 unified agenda for the Department of Health and Human Services, FDA plans to recommend several changes to U.S. OTC drug labeling, safety monitoring, and manufacturing standards in 2013 which may impact future marketing and product development strategies for consumer products. Forthcoming FDA proposals include the following:  Proposed Monograph Modifications  Amending the … Continue Reading

GAO Report Encourages FDA to Strengthen Its Food Advisory and Recall Process

In January 2011, the FSMA amended the Federal Food, Drug, and Cosmetic Act to give the Food & Drug Administration (FDA) authority to order the recall of all food products when a company fails to voluntarily recall the products. Until passage of this act, FDA could ask companies to voluntarily recall adulterated or misbranded food … Continue Reading

FDA Proposed Rule Would Place New Labeling and Reporting Requirements on Medical Device Manufacturers

On July 10, 2012, the Food and Drug Administration (“FDA”) published a proposed rule implementing Federal Food, Drug, and Cosmetic Act (“FD&C Act”) provisions establishing a unique device identification system for medical devices over the next seven years. The rule would require medical device manufacturers—including a specification developer, a single-use device reprocessor, a convenience kit … Continue Reading

Dietary Guidelines for Americans, 2010

On January 31, 2011 the U.S. Department of Agriculture (USDA) and U.S. Department of Health and Human Services (HHS) issued the Dietary Guidelines for Americans, 2010. A copy of the executive summary is available here. Supporting documents include Questions and Answers on the 2010 Dietary Guidelines, a Backgrounder regarding the History and Process for the … Continue Reading

The 2010 Dietary Guidelines Advisory Committee Calls for a Coordinated Strategic Plan and Evidence-Based Actions to Help All Americans Adopt Health-Promoting Behaviors and Bring an End to the Obesity Crisis

This post was written by Sarah Roller. On June 15, 2010, the Dietary Guidelines Advisory Committee issued the “Report of the Dietary Guidelines Advisory Committee on the Dietary Guidelines for Americans, 2010” (“Advisory Report” or “Report”). The Advisory Report is intended to provide the United States Department of Agriculture (USDA) and the Department of Health … Continue Reading