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DELAYED: The FDA’s Intended Use Rule

Written by Michael A. Walsh on March 21, 2017

The effective date of FDA’s Intended Use Rule has been extended until March 19, 2018.  The comment period will remain open until May 19, 2017. The FDA is delaying the effective date to invite public comment on substantive issues raised in a Citizen’s Petition.  The Petition was filed on behalf of the Medical Information Working Read More…


FDA Provides a Healthy Extension to Comment on Healthy

Written by Michael A. Walsh on December 30, 2016

In September 2016, the Food and Drug Administration (FDA) took a number of actions concerning the use of the term “Healthy” in the labeling of food products. The FDA published notice in the Federal Register on the use of the term, published a “Guidance for Industry: Use of the Term “Healthy” in the Labeling of Human Read More…


Naturally FTC Rules

Written by Michael A. Walsh on December 22, 2016

FTC Finds “All Natural” and “100% Natural” Claims False and Misleading In April 2016, four companies[i] marketing skin care products online agreed to settle Federal Trade Commission (FTC) charges that the companies’ advertisements violated the Federal Trade FTC Act (the Act). According to the FTC complaints, claims that the products were “all natural” or “100% Read More…


FDA Final Rule on the Submission of Import Data

Written by Michael A. Walsh on December 5, 2016

On November 29, 2016, the Food and Drug Administration (FDA) issued a Final Rule on the Submission of Import Data in the Automated Commercial Environment (ACE). The final rule specifies certain data that must be submitted when an FDA-regulated product is offered for import into the United States. The effective date of the rule is Read More…


Drug Law: Off-Label Use – a Paradigm Shift and a Moral Imperative

Written by Michael A. Walsh on November 21, 2016

On December 16, 2016, the State Bar of Texas will host a Webcast on the FDA and Off-Label Uses of Medical Products. Coincidentally in the wake of the 2016 presidential election, the Food and Drug Administration (FDA) is reevaluating its rules on how drug and device companies disseminate information. The change that the FDA is Read More…



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