Topic: FDA & Food Safety

COVID-19 Update: Biopharmaceutical Executives Release Joint Statement on Vaccine

Chief executive officers of nine biopharmaceutical companies signed an unprecedented joint pledge, entitled BIOPHARMA LEADERS UNITE TO STAND WITH SCIENCE, acknowledging the U.S. Food and Drug Administration’s (“FDA”) role in the development of a COVID-19 vaccine, and pledging to: Always make the safety and well-being of vaccinated individuals our top priority. Continue to adhere to … Continue reading

COVID-19 Update: FDA revokes EUA for malaria drugs used as COVID-19 treatment

By Yvonne Puig (US), Daphne Calderon (US) and Jeff Wurzburg (US) on June 15, 2020 Posted in Coronavirus, FDA & Food Safety, General

On June 15, 2020, the U.S. Food and Drug Administration (FDA) revoked emergency use authorization (EUA) for chloroquine (CQ) and hydroxychloroquine (HCQ). The FDA found that the criteria for issuance of the EUA are no longer met and “in light of ongoing reports of serious cardiac adverse events and several newly reported cases of methemoglobinemia … Continue reading

COVID-19 Update: FDA will use enforcement discretion for limited ventilator modifications

By Yvonne Puig (US), Thomas Dowdell (US), Mark Faccenda (US) and Jeff Wurzburg (US) on March 23, 2020 Posted in Coronavirus, FDA & Food Safety, General

On March 22, 2020, the FDA released guidance describing an enforcement policy that will help increase the availability of ventilators and accessories, as well as other respiratory devices, during the COVID-19 pandemic. FDA’s guidance would permit “limited modifications to the indications, claims, functionality, or to the hardware, software, or materials of FDA-cleared devices used to … Continue reading

FDA Final Rule Amends Definition of “Biological Product”

By Rachel Park (US), Jeff Wurzburg (US) and Mark Faccenda (US) on March 3, 2020 Posted in FDA & Food Safety, General

On February 20, 2020 the U.S. Food and Drug Administration (FDA) published a final rule, revising the regulatory definition of biological products to match the definition Congress agreed to in the Further Consolidated Appropriations Act, 2020. The changes reflect the FDA’s efforts to remove regulatory hurdles in order to create cheaper versions of biological products, … Continue reading

CY 2020 Medicare Hospital Outpatient Prospective Payment System and Ambulatory Surgical Center Payment System Final Rule

By Thomas Dowdell (US), Mark Faccenda (US) and Jeff Wurzburg (US) on November 11, 2019 Posted in FDA & Food Safety, News from DC, Regulatory

On November 1, 2019, the Centers for Medicare & Medicaid Services (CMS) published its CY 2020 Medicare Hospital Outpatient Prospective Payment System (OPPS) and Ambulatory Surgical Center (ASC) Payment System final rule. The final rule implements a number of significant changes to payment policies and rates for services furnished to Medicare beneficiaries in hospital outpatient … Continue reading

FDA publishes new 510(K) guidance

By Yvonne Puig (US), Mark Faccenda (US) and Jeff Wurzburg (US) on January 24, 2019 Posted in FDA & Food Safety

On January 22, 2019, the FDA released nonbinding guidance expanding the Abbreviated 510(k) program used to show the safety and efficacy of medical devices. A new “safety and performance-based pathway” for certain, well understood device types, may be used by manufacturers to demonstrate substantial equivalency to devices already on the market. Under the 510(k) process, … Continue reading

FDA releases new guidance on off-label promotion

By Benjamin Wallfisch (US) on June 19, 2018 Posted in FDA & Food Safety

Last week, the U.S. Food and Drug Administration (“FDA”) released two guidance documents that relate to sharing of certain information about drugs and medical devices, including economic information about unapproved products and unapproved uses, as well as information not included in a product’s FDA-approved labeling. These guidance documents are part of broader blueprint published by … Continue reading

Recent effort to regulate pharmaceutical pricing deemed unconstitutional by Fourth Circuit

By Robin Adelstein (US) on April 17, 2018 Posted in Enforcement, FDA & Food Safety, News from DC, Regulatory

In the absence of federal action, states have attempted to rein in high pharmaceutical pricing by enacting laws aimed at regulating drug pricing. Following what now has become a trend, on March 13, 2018, Oregon became the newest state to enact such legislation, The Prescription Drug Price Transparency Act, H.B. 4005. But many of these … Continue reading

FDA relaxes FSMA enforcement

By on January 9, 2018 Posted in FDA & Food Safety

On January 5, 2018, the U.S. Food and Drug Administration (“FDA”) released guidance entitled Policy Regarding Certain Entities Subject to the Current Good Manufacturing Practice and Preventive Controls, Produce Safety, and/or Foreign Supplier Verification Programs: Guidance for Industry. The guidance states that FDA will exercise enforcement discretion for certain parts of the Food Safety Modernization … Continue reading

FDA commissioner discusses key policy goals for 2018

By on December 19, 2017 Posted in FDA & Food Safety

On December 14, 2017, the Commissioner of the U.S. Food and Drug Administration (“FDA”), Dr. Scott Gottlieb, posted Looking ahead: Some of FDA’s major policy goals for 2018 on FDA’s blog, FDA Voice, and discussed FDA’s policy agenda published on the Unified Agenda of Federal Regulatory and Deregulatory Actions (“Unified Agenda”), which provides the public … Continue reading

FDA commissioner discusses upcoming guidance to modernize its framework for medical device review

By on December 13, 2017 Posted in FDA & Food Safety

On December 11, 2017, the U.S. Food and Drug Administration (“FDA”) Commissioner, Scott Gottlieb, posted Advancing Policies to Promote Safe, Effective MedTech Innovation on FDA’s blog, FDA Voice and discussed FDA’s plans to modernize its policy framework for the review of new medical devices. These changes will require FDA to make the review process more … Continue reading

FDA embraces medical innovation in 2017

By on November 27, 2017 Posted in FDA & Food Safety

On November 16, 2017, the US Food & Drug Administration (“FDA”) unveiled a comprehensive policy framework – a suite of four guidance documents – to oversee regenerative medicine products. Regenerative medicine is the science of restoring structure and function to damaged or diseased cells, tissues, or organs. The two final guidance documents outline when cell … Continue reading

FDA commissioner looks to curb tactics that restrict drug competition

By on November 13, 2017 Posted in FDA & Food Safety

On November 8, 2017, the U.S. Food and Drug Administration (“FDA”) Commissioner Scott Gottlieb spoke as a keynote speaker at the Federal Trade Commission (“FTC”) workshop, Understanding Competition in Prescription Drug Markets: Entry and Supply Chain Dynamics (“Workshop”) and called to “end the shenanigans” that can delay or restrict generic drug competition. Gottlieb discussed his … Continue reading

FDA commissioner discusses greater scrutiny of health claims on food packaging

By on October 13, 2017 Posted in FDA & Food Safety

On October 10, 2017, the U.S. Food and Drug Administration (“FDA”) Commissioner Scott Gottlieb spoke at the Wall Street Journal Global Food Forum (“Forum”) and shed light on his views regarding food labeling. Specifically, Dr. Gottlieb said that he wants FDA to take a closer look at the health claims on food packaging. He further … Continue reading

Restaurant and convenience store trade groups sue NYC over menu labeling regulations

By on July 24, 2017 Posted in FDA & Food Safety

On July 14, 2017, the National Association of Convenience Stores, New York Association of Convenience Stores, Food Marketing Institute, and Restaurant Law Center (“trade groups”) filed a lawsuit against the New York City Department of Health and Mental Hygiene and its Commissioner Dr. Mary Travis Bassett, the New York City Board of Health, and the … Continue reading

FDA extends compliance date for Nutrition Facts Label rule

By on June 16, 2017 Posted in FDA & Food Safety

On June 13, 2017, the US Food and Drug Administration (“FDA”) announced that it was extending the compliance date for the Nutrition Facts Label rule. The FDA will provide the final details regarding the extension of the compliance date through a Federal Register Notice that it will publish at a later date. The FDA released … Continue reading

Mandatory kilojoule labeling – Victoria, Australia

By on May 18, 2017 Posted in FDA & Food Safety, International

The Victorian Government has introduced the requirement that all major Victorian food outlets and supermarket chains must display kilojoule contents on their menus. The Food (Kilojoule Labelling Scheme and Other Matters) Amendment Act 2016 will, from May 2018, require large chain food businesses and large chain supermarkets to display: the average kilojoule content of standardised, … Continue reading

FDA announces plans to create a centralized digital health unit

By Benjamin Wallfisch (US) on May 9, 2017 Posted in FDA & Food Safety

The U.S. Food and Drug Administration (“FDA”) has announced plans to create a centralized digital health unit within the Center for Devices and Radiological Health (“CDRH”), further supporting CDRH’s 2016-2017 vision to establish a more robust national evaluation system for medical devices. FDA will form the new digital health unit within CDRH’s Office of the … Continue reading

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