The U.S. Food and Drug Administration issued draft guidance, Clinical Trial Considerations to Support Accelerated Approval of Oncology Therapeutics, regarding clinical trial design considerations to support accelerated approval applications. The accelerated approval pathway is commonly used for approval of oncology drugs in part due to the serious and life-threatening nature of cancer and because of available intermediate clinical endpoints likely to predict clinical benefit.

“The FDA’s accelerated approval program has provided patients with cancer earlier access to novel treatments that can be practice changing,” said Richard Pazdur, MD, Director of the FDA’s Oncology Center of Excellence. “Today’s draft guidance provides recommendations to sponsors for designing clinical trials to support accelerated approval. Building quality and efficiency into the design of oncology clinical trials is a crucial component in providing maximum benefit to those living with cancer.”

The draft guidance discusses the design of clinical trials, and ways to improve the data available at the time of accelerated approval and reduce clinical uncertainty for patients by initiating postmarketing confirmatory studies in a timely manner. Specifically, the draft guidance addresses the design, conduct and analysis of data through two randomized clinical trial approaches – conducting two separate randomized controlled clinical trials or using one trial for both accelerated approval and to verify clinical benefit. The draft guidance also provides considerations for sponsors to determine the adequacy of single-arm studies to support an application.
  
For drugs granted accelerated approval, postmarketing confirmatory trials have been required to verify and describe the anticipated clinical benefit. The draft guidance discusses a potential advantage of randomized clinical trials–compared to single-arm trials–by highlighting that use of the one-trial approach, in appropriate cases, may not require separate clinical trials because longer term follow-up in the same trial could fulfill a postmarketing requirement to verify clinical benefit. Moreover, confirmatory trials that are in progress at the time of accelerated approval are more likely to result in a timely verification of clinical benefit, therefore minimizing the period of uncertainty for patients.

In a commentary in the New England Journal of Medicine in 2022External Link Disclaimer, Oncology Center of Excellence staff outlined the concepts included and expanded upon in the draft guidance. The Oncology Center of Excellence has also launched Project Confirm, as an initiative that promotes the transparency of outcomes related to accelerated approval for oncology indications and  fosters discussion and research on the accelerated approval program. The project developed a searchable database with information on the status of all oncology accelerated approvals, a model that was then adopted by FDA’s Center for Drug Evaluation and Research for all accelerated approvals.

Related Information

• Oncology Center of Excellence Guidance Documents
• Clinical Trial Considerations to Support Accelerated Approval of Oncology Therapeutics Guidance for Industry 
• Accelerated Approval Program
• Project Confirm

Source: FDA

The U.S. Food and Drug Administration today issued draft guidance that provides food manufacturers with recommendations on how and when to use Dietary Guidance Statements on the label of food products to ensure the label statements promote good nutrition, provide greater consistency in labeling, and assist consumers in making informed choices. This guidance is part of the FDA’s overall goal to help reduce the burden of chronic disease and advance health equity through improved nutrition. 

“Diet-related chronic diseases, are the leading causes of death and disability in the U.S. and disproportionally impact communities of color and people living in rural areas,” said FDA Commissioner Robert M. Califf, M.D. “The FDA is committed to being a part of the solution to improve the health of millions of Americans. Today’s action is another step towards helping consumers make informed choices about the foods they eat.”

Today’s eating patterns in the U.S. do not align with current federal dietary recommendations, which focus on the entirety of the diet and how foods and beverages work together to affect health. Dietary Guidance Statements are statements in food labeling which are based on key recommendations from consensus reports, such as the Dietary Guidelines for Americans, 2020-2025, that discuss how a food or food group can be a part of a nutritious dietary pattern. The statements may include symbols or pictures that convey to consumers that a food or a food group may contribute to, or help maintain, a nutritious dietary pattern. 

Examples of Dietary Guidance Statements include: “Make half your grains whole grain,” and “Eat leafy green vegetables as part of a nutritious dietary patten.” The draft guidance provides the agency’s thinking about the use of such statements, including recommendations that products contain a meaningful amount of the food, or category of foods, that is the subject of the statement, and that they also not exceed certain amounts of saturated fat, sodium and added sugars. The recommendations in the guidance can enhance consistency in the use of such statements and consumer understanding as well as facilitate industry innovation toward healthier foods. Like other labeling statements and claims, Dietary Guidance Statements act as quick signals on food packages to help consumers better understand nutrition information and make healthier food choices. 

Today’s action is part of the FDA’s overall nutrition initiatives, which include empowering consumers by providing more informative labeling and education, including tailored messages for various audiences to help consumers identify foods that can contribute to healthier diets. It is also part of the Biden-Harris Administration’s National Strategy on Hunger, Nutrition, and Health, which provides a roadmap of actions the federal government will take to end hunger and reduce diet-related diseases by 2030 – all while reducing disparities. Complementing today’s guidance and the National Strategy, the FDA issued a proposed rule in September 2022 to update the definition of “healthy” on food labels and help consumers more easily identify healthy food choices. The agency’s work also supports the Biden-Harris Administration’s White House Challenge to End Hunger and Build Healthy Communities, a nationwide call-to-action to stakeholders across all of society to make bold commitments to advance the Strategy’s goals. The 
Challenge builds on the success of the $8 billion package of private and public sector commitments that the Administration announced as part of the historic conference.

Another priority of the FDA’s nutrition efforts is to create a healthier food supply for all. In October 2021, the FDA issued final guidance for the food industry that provided voluntary, short-term sodium reduction targets for a broad range of processed, packaged and prepared foods to help reduce the amount of sodium in the U.S. food supply. 

“In addition to the Dietary Guidance Statements draft guidance, reducing sodium intake and updating the definition of “healthy” are two other examples of how the agency is showing its commitment to fostering a healthier food supply for all and empowering consumers with more informative and accessible labeling to choose healthier diets,” said Susan Mayne, Ph.D., director of the FDA’s Center for Food Safety and Applied Nutrition. “We are making great strides in our nutrition initiatives in order to improve the health and wellness of our nation.” 

The FDA remains committed to doing its part in the all-of-government approach to improving nutrition, which can have a lasting generational impact on reducing chronic diseases and advancing health equity. The agency is moving forward with additional nutrition and labeling priorities, including exploring a “front-of-pack” labeling initiative and recommendations for nutrition labeling for online grocery shopping sites. Additionally, the FDA will begin assessing further strategies to reduce added sugar consumption, which includes collaborating with others in the U.S. Department of Health and Human Services and the U.S. Department of Agriculture to hold a public meeting regarding future steps the federal government could take to reduce intake of added sugars.

Related Information

• Draft Guidance: Questions and Answers About Dietary Guidance Statements in Food Labeling: Guidance for Industry
• Constituent Update: FDA Issues Draft Guidance on Dietary Guidance Statements on Food Labels
• Press Release: FDA Proposes Updated Definition of ‘Healthy’ Claim on Food Packages to Help Improve Diet, Reduce Chronic Disease
• Press Release: To Improve Nutrition and Reduce the Burden of Disease, FDA Issues Food Industry Guidance for Voluntarily Reducing Sodium in Processed and Packaged Foods
• FDA’s Nutrition Initiatives

Source: FDA

• The Concussion Awareness Now campaign raises awareness both about the common, everyday ways concussions most often happen and the importance of getting concussions evaluated
• Concussion Awareness Now is a coalition of nearly 20 advocacy groups, founded by Abbott and the Brain Injury Association of America, with Rebel Wilson as the group’s inaugural spokesperson
• The campaign addresses the fact that more than half of people who suspect they have a concussion never get it checked and features a family of characters called the Melons

ABBOTT PARK, Ill., and FAIRFAX, Va. /PRNewswire/ — Concussion Awareness Now, a coalition of nearly 20 advocacy groups founded by Abbott (NYSE: ABT) and the Brain Injury Association of America, unveiled today a new public service campaign to draw attention to concussions and the importance of seeking care.

Experience the interactive Multimedia News Release here: https://www.multivu.com/players/English/9143051-abbott-dont-mess-with-your-melon-the-concussion-awareness-now-campaign/

The majority of concussions happen during everyday activities – and more than half of people who suspect they have a concussion never get it checked, according to a recent coalition survey.

The new public service announcement campaign raises awareness both about the common ways concussions happen and the importance of getting them evaluated. Playing off the fact that people sometimes refer to their brain as their “melon,” the campaign features a family of animated characters called the Melons, designed to connect with a wide audience by showcasing real-life situations where head injuries occur. Further, the spots encourage people to get their heads checked for a possible concussion, even if they are hesitant or feel pressure not to. The characters span three generations: grandparents, parents and children.

“Too often people think it’s OK to walk off a possible concussion,” said Dr. Beth McQuiston, neurologist and medical director in Abbott’s diagnostics business. “But like a bruised melon, which can suffer unseen damage beneath the surface, a concussion is a serious injury that isn’t always obvious to the naked eye. By driving awareness, we hope more people will seek care for possible concussions when they hit their head, because you can’t treat what you don’t know.”

Each public service announcement features a Melon character hitting his or her head in a different way: slipping on a toy, texting and walking, tripping over the family pet during a virtual reality game, and playing pickleball. Each spot ends with the tagline, “Don’t mess with your melon – if you hit it, get it checked.” The campaign is launching across digital and social channels.

A survey of 3,000 people conducted by the coalition in November of 2022 highlighted many of the misconceptions about concussions. For example, even though only 3% of concussions that present to the emergency room are the result of sports injuries, 84% of respondents believed athletes are the most at risk for concussion. The leading cause of concussions is slips and falls.

“Most concussions happen to people participating in regular, everyday activities,” said Rick Willis, president and chief executive officer of the Brain Injury Association of America. “In the brain injury community, we take concussions – and their after-effects – very seriously. But not everyone has the same understanding of what situations are most likely to cause concussions or what to do when they experience a hit or bump to the head or a full-body jolt. The Melons offer a unique way to spread awareness about concussions: if you think you or a loved one has sustained a concussion, it’s imperative to get it checked.”

Abbott and the Brain Injury Association of America launched the Concussion Awareness Now coalition in December. The coalition of advocacy groups has teamed up with acclaimed actress, comedian, writer and producer Rebel Wilson to raise awareness about the seriousness of concussions. Wilson has shared her personal concussion story as part of the coalition’s campaign and will appear with the Melons in online content. Wilson suffered a concussion when she slipped on wet grass while walking to the set of a movie.

Concussion Awareness Now is made up of advocacy groups that represent people who have sustained brain injuries – from veterans, older adults and victims of domestic violence – their caregivers, as well as healthcare professionals such as emergency care physicians, physicians assistants, urgent care workers and athletic trainers. The coalition website, CheckYourMelon.com, features information about concussion, tips for seeking treatment, frequently asked questions, a patient question guide and other resources.

About the Brain Injury Association of America
The Brain Injury Association of America is the country’s oldest and largest nationwide brain injury advocacy organization. Our mission is to advance awareness, research, treatment, and education and to improve the quality of life for all people affected by brain injury. We are dedicated to increasing access to quality health care and raising awareness and understanding of brain injury.

Learn more at www.biausa.org, on Facebook at www.facebook.com/BrainInjuryAssociationofAmerica, on Instagram at @bia_usa, and on LinkedIn at www.linkedin.com/company/brain-injury-association-of-america.

About Abbott
Abbott is a global healthcare leader that helps people live more fully at all stages of life. Our portfolio of life-changing technologies spans the spectrum of healthcare, with leading businesses and products in diagnostics, medical devices, nutritionals and branded generic medicines. Our 115,000 colleagues serve people in more than 160 countries.

Connect with us at www.abbott.com, on LinkedIn at www.linkedin.com/company/abbott-/, on Facebook at www.facebook.com/Abbott and on Twitter @AbbottNews.

SOURCE Abbott