On December 28, 2016, the U.S. Food and Drug Administration (FDA) released final guidance on the management of cybersecurity vulnerabilities for marketed and distributed medical devices. The guidance establishes a risk-based approach for the reporting of medical device cybersecurity vulnerabilities to the FDA. The FDA guidance reflects the agency’s concerns that cybersecurity vulnerabilities in networked … Continue reading
The Food and Drug Administration’s (FDA) Office of Prescription Drug Promotion (OPDP) focused its end-of-year enforcement efforts on drug manufacturers’ promotions on tv, social media ads, and electronic promotion efforts. The OPDP issued in December six of its eleven total enforcement letters for 2016. The eleven disciplinary letters represents a small spike from previous years’ … Continue reading
The U.S. Food and Drug Administration (“FDA”) regulates the use of social media to disseminate information about prescription drugs and medical devices. Our firm sister blog, the Social Media Law Bulletin, previously covered the social media guidance released by the FDA in 2014, and a sampling of Warning and Untitled Letters that the FDA has issued to … Continue reading
The Food and Drug Administration (“FDA”) released its final guidance on medical device safety on December 14, 2016, titled “Public Notification of Emerging Postmarket Medical Device Signals (Emerging Signals).” The final guidance comes almost a year after FDA issued a similar draft guidance on the topic. As with the draft guidance, industry remains concerned about … Continue reading
On October 17, 2016, a US federal trial court in the District of Columbia ruled that a competitor may pursue a Lanham Act claim for false advertising due to a container of black pepper. Watkins Inc. v. McCormick & Co., Inc., Case No. 1:15-cv-2188 (ESH) (D.D.C. Oct. 17, 2016) (2016 WL 6078250). In ruling on … Continue reading
The US Food and Drug Administration (“FDA”) announced on November 18, 2016 that it will not release a final guidance to regulate laboratory developed tests (“LDTs”), in vitro diagnostic tests designed, manufactured, and used within a single laboratory. The announcement marks a significant reversal from the previous positions of the Obama administration, FDA, and specifically, Dr. … Continue reading
In an Advisory Opinion issued on September 23, 2016, the U.S. Department of Health and Human Services Office of Inspector General (“OIG”) announced that it would not impose administrative sanctions against the manufacturer of a vaccine refrigeration system (the “Requestor”) for providing the devices to physicians without charge. This development comes at a critical time … Continue reading
Last week, the Ninth Circuit affirmed a physician’s conviction for conspiracy to distribute an adulterated device with intent to defraud or mislead in violation of Section 331(k) of the federal Food, Drug and Cosmetic Act (FDCA). The physician – who dubbed his own practice “The McDonald’s of Urology” because of the high volume of patients … Continue reading
Last week, HHS, OIG, CMS, the Office of the Assistant Secretary for Financial Resources, and the Administration for Children and Families issued an interim final rule (the Rule) that adjusts maximum civil monetary penalties for inflation.… Continue reading
On August 31, 2016, the U.S. Food and Drug Administration (“FDA”) announced class-wide drug labeling changes aimed at providing better information to health care providers and patients. FDA’s guidance warns of the risks associated with combined use of certain opioid medicines and benzodiazepines. FDA prepared a Drug Safety Communication directed to health care professionals and … Continue reading
Food Standards Australia New Zealand (FSANZ) is calling for submissions in response to its draft variation of the Food Standards Code that would permit the sale of foods derived from low tetrahydrocannbinol (THC) hemp. The proposal follows a request by the Australia and New Zealand Ministerial Forum on Food Regulation (Forum) for FSANZ to consider … Continue reading
On July 26, 2016, the FDA issued draft guidance to help clarify the form and content requirements of the Unique Device Identifier (UDI). Industry groups have 60 days to comment on the draft guidance. Background The UDI final rule, which established the UDI system, was published on September 24, 2013. The rule aims to develop … Continue reading
On June 23, 2016, the Senate Agriculture Committee agreed to a bipartisan deal that would set a national standard for GMO labeling. The National Bioengineered Food Disclosure Standard would amend The Agricultural Marketing Act of 1946 by setting forth mandatory disclosure requirements for GMO food products, while providing a variety of options to the industry … Continue reading
Summary On May 4, 2016, the U.S. Food and Drug Administration (FDA) signed a “systems recognition arrangement” with the Canadian Food Inspection Agency (CFIA) and Health Canada recognizing the comparability of the U.S. and Canadian food safety systems. This is only the second time that the FDA has recognized a foreign food safety system as … Continue reading
On June 1, 2016, the US Food and Drug Administration (FDA) published in the Federal Register (81 Federal Register 35032) a draft guidance for sponsors, clinical investigators, industry, IRBs, and FDA staff regarding categorization of Investigational Device Exemption (IDE) devices as either a Category A or Category B device to assist the Centers for Medicare and … Continue reading
The 7th and final Food Safety Modernization Act (FSMA) implementing rule is finally here and most companies will have three years to comply. On May 26, 2016, the FDA finalized the Mitigation Strategies to Protect Food Against Intentional Adulteration rule. The effective date of the rule is May 27, 2016, the date of the rule’s … Continue reading
On May 26, 2016, the Food and Drug Administration (FDA) approved Probuphine as part of a targeted initiative by the U.S. Department of Health and Human Services (HHS) and the FDA to reduce prescription opioid and heroin-related overdose, death and dependence.… Continue reading
Added Sugars are in. Calories From Fat are out. And would the typical American eat the package of food in one sitting? If so, those Americans will now know from the label what they will consume in that sitting.… Continue reading
The Australian Labor Party has flagged the data exclusivity provisions of the Trans Pacific Partnership Agreement (TPP) as a major issue ahead of our now confirmed July date for an Australian election.… Continue reading
On April 29, 2016, the US Food and Drug Administration (“FDA”) issued the final guidance on menu labeling titled “A Labeling Guide for Restaurants and Retail Establishments Selling Away-From-Home Foods – Part II.”… Continue reading
Summary From 1 July 2016, new country of origin labeling requirements will become a reality in Australia, with a new food labeling system commencing under the Australian Consumer Law. The implementation of the new system will have a two year transition period. From 1 July 2018, the new system will be mandatory and something which … Continue reading
On February 8, 2016, the U.S. Food and Drug Administration (FDA) issued a Product Problem Report concerning the following device: Merge Hemo Programmable Diagnostic Computer, manufactured by Merge Healthcare. The Merge Hemo device monitors, measures and records physiological data from patients undergoing cardiac catheterization procedures and transfers this data to a monitoring station that runs … Continue reading
Australia’s country of origin labelling system for food products is to be overhauled following agreement by State and Territory Ministers for Consumer Affairs. Food offered for retail sale in Australia will be required to be labelled more clearly to inform consumers of the product’s origins.… Continue reading
The use of cannabis for restricted medical purposes is set to be legalised in Victoria following the passing of the Access to Medicinal Cannabis Bill 2015. The Bill creates a new legal regime that regulates the cultivation, manufacture and supply of cannabis in Victoria, and allows for specified categories of patients to have access to … Continue reading