Topic: FDA & Food Safety

Latest Executive Order shows support for agribusiness development and food safety

By on May 1, 2017 Posted in FDA & Food Safety

On April 25, 2017, President Trump issued the Presidential Executive Order on Promoting Agriculture and Rural Prosperity in America. The Executive Order established the Interagency Task Force on Agriculture and Rural Prosperity that will identify legislative, regulatory, and policy changes to promote in rural American agriculture, such as economic development, job growth, and infrastructure improvement. … Continue reading

Court upholds Health Canada decision requiring additional information ‎on certain Apotex drugs manufactured in India

By Ian Trimble (CA), Kristin Wall (CA) and Sara Zborovski (CA) on April 6, 2017 Posted in FDA & Food Safety, International

The Federal Court dismissed Apotex’s application for judicial review of the Minister of Health’s decision to require additional information from Apotex as part of its submissions for certain drugs manufactured in India by Apotex affiliates. Read the full update here.… Continue reading

Global health trends impacting the regulation of food and beverage labels

By Georgina Hey (AU) and Isobel Taylor (AU) on February 3, 2017 Posted in FDA & Food Safety, International

As global rates of obesity and related diseases continue to rise, consumers around the world are becoming more health conscious, and are expecting their food products to reflect their desire for healthier options. A recent Nielsen Global Health and Wellness Survey found that, of the 30 000 people across 60 countries surveyed, 49% consider themselves … Continue reading

Health Canada releases draft guidance documents for consultation related to good manufacturing practices and drug establishment licensing

By Jillian Hyslop (CA) and Sara Zborovski (CA) on February 1, 2017 Posted in FDA & Food Safety, International

On January 18, 2017, Health Canada released five draft guidance documents for consultation relating to good manufacturing practices and drug establishment licensing. The consultation period is open until April 18, 2017. Read the full update in Norton Rose Fulbright’s Pharma in brief – Canada.… Continue reading

FDA receives citizen petition regarding labeling of added sugars in food

By on February 1, 2017 Posted in FDA & Food Safety

On January 25, 2017, the nonprofit science group, Union of Concerned Scientists, filed a citizen petition with the U.S. Food and Drug Administration (“FDA”), urging the FDA to prohibit foods with high amounts of added sugars from being labeled or advertised as nutritious or healthy. The petition is open for public comment until July 25, … Continue reading

New proposed food safety regulations open for comments

By Sara Zborovski (CA) on January 31, 2017 Posted in FDA & Food Safety

They’re finally here! The long-awaited Safe Food for Canadians Regulations have been pre-published in the Canada Gazette I for comment, and the CFIA has officially kicked off consultation on the proposed regulations. The proposed Regulations are made under the Safe Food for Canadians Act (the “Act”), which was adopted back in 2012 with a view … Continue reading

21st Century Cures Act: impact on FDA

By Benjamin Wallfisch (US) on January 30, 2017 Posted in FDA & Food Safety, News from DC

On December 13, 2016, President Obama signed into law the 21st Century Cures Act (the “Cures Act”). We detailed the Cures Act’s provisions affecting hospitals in a prior Health Law Pulse post and will focus on a more in-depth analysis of its impact on the U.S. Food and Drug Administration (the “FDA”) here. The Cures … Continue reading

Just before inauguration, FDA issues memo to address off-label promotion

By Leaf McGregor (US) on January 30, 2017 Posted in FDA & Food Safety, News from DC

On January 18, 2017, two days before President Trump took office, the US Food and Drug Administration (FDA) issued two pieces of draft guidance for off-label communications. The first addresses communications with payors and formulary committees, and the second outlines “Questions and Answers” about how FDA evaluates communications about information not contained in approved labels … Continue reading

How pharma cos. can shape the drug-pricing landscape

By Robin Adelstein (US) on January 25, 2017 Posted in Enforcement, FDA & Food Safety, News from DC, Regulatory

Unless you have been living under a rock, you no doubt have noticed that drug price increases have resulted in a wave of public criticism, playing right into the media’s demonization of the pharmaceutical industry, and even becoming an election year issue. The United States is one of the only developed nations that largely does … Continue reading

FDA approves opioid drug Arymo ER for chronic pain management

By Yvonne Puig (US) and Mark Faccenda (US) on January 12, 2017 Posted in FDA & Food Safety

On January 9, 2017, the US Food and Drug Administration (“FDA”) approved opioid drug Arymo ER (morphine sulfate) manufactured by Egalet US, Inc. (“Egalet”) for use in the management of pain severe enough to require long-term opioid treatment, and where alternative treatment options are inadequate. In its approval, FDA explains that typical post-marketing surveillance of adverse … Continue reading

FDA issues final guidance on postmarket medical device cybersecurity

By Anna Rudawski (US) on January 6, 2017 Posted in FDA & Food Safety

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

FDA enforcement spike targets drug promotions

By on January 5, 2017 Posted in Enforcement, FDA & Food Safety

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

FDA finalizes guidance on medical device safety

By Carol Poindexter (US) on December 19, 2016 Posted in FDA & Food Safety

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

Sugar, Salt and Fat : the Usual Suspects Targeted by Health Canada’s Proposed Mandatory Front-Of-Package Labelling System

By Sara Zborovski (CA) on December 14, 2016 Posted in FDA & Food Safety

Health Canada is contemplating mandatory front-of-package (FOP) labelling for prepackaged foods high in “nutrients of public concern”, namely sugars, sodium and saturated fat. This is one of the key initiatives put forward by Health Canada as part of its Health Eating Strategy, announced on October 24, 2016. A public consultation was launched on November 14, … Continue reading

Package as “Advertising”

By Susan Ross (US) and Robert Rouder (US) on December 7, 2016 Posted in FDA & Food Safety, News from DC

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

FDA delays lab developed test guidance

By on November 23, 2016 Posted in FDA & Food Safety

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

FDA now demands its strongest black box warnings for certain opioid and other drugs

By Yvonne Puig (US) and Mark Faccenda (US) on September 1, 2016 Posted in FDA & Food Safety

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

Australia: Regulator considers permitting the sale of food derived from low THC hemp seeds

By Bernard O'Shea (AU) and Rohan Sridhar (AU) on August 22, 2016 Posted in FDA & Food Safety

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

FDA issues draft guidance on Unique Device Identifiers

By Mark Faccenda (US) on August 4, 2016 Posted in FDA & Food Safety

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

Senate agriculture committee reaches deal on national GMO labeling bill

By on June 24, 2016 Posted in FDA & Food Safety, News from DC

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

U.S. Food and Drug Administration announces new partnership with Canadian Food Inspection Agency on food safety

By Sara Zborovski (CA) and Jillian Hyslop (CA) on June 13, 2016 Posted in FDA & Food Safety

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

FDA draft guidance to assist CMS with coverage decisions for Medicare payment

By Thomas Dowdell (US) and Mark Faccenda (US) on June 8, 2016 Posted in FDA & Food Safety

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

FDA issues final FSMA implementing rule

By on May 31, 2016 Posted in FDA & Food Safety

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