Updates
Spotlight!
FDA Issues Framework for Digital Health Technologies
FDA issued the Framework for the Use of Digital Health Technologies in Drug and Biological Product Development. The Digital Health Technology (DHT) framework document will guide the use of DHT-derived data in regulatory decision-making for drugs and biological products.
The document outlines the framework FDA will use to implement a multifaceted DHT program for drugs and biological products. The DHT program will engage stakeholders and include workshops and demonstration projects; establish internal processes to support DHT evaluation for use in drug development; promote shared learning and consistency for DHT-based policy, procedure, and analytic tool development; and facilitate the publication of relevant guidance documents.
FDA Releases New Educational Resources for Patients on Biosimilars
The FDA released new educational materials for patients related to biosimilars and interchangeable biosimilars – two fact sheets: Biosimilars What Patients Need to Know, Biosimilars What Patients with Diabetes Need to Know, and an infographic: Biosimilar Basics Infographic for Patients.
The materials for patients are also available in Spanish: Biosimilares: Lo Que los Pacientes Deben Saber, Biosimilares: Lo Que los Pacientes con Diabetes Deben Saber, and Conceptos Básicos Sobre los Biosimilares.
Consumer Updates
Colorectal Cancer: What You Should Know About Screening
The evidence is clear - screening for colorectal cancer may save your life. Today, more and more people are choosing colorectal cancer screening. As a result, there is a steady decline in the number of older people getting and dying from colorectal cancer. Lower rates of smoking among Americans have also contributed to the decline in the past several years.
Colorectal cancer usually starts from polyps or other precancerous growths in the rectum or the colon (large intestine). The only way to find a polyp, precancerous growth, or colorectal cancer is to do a screening test or procedure.
FDA Voices
How FDA’s Strategy Helps Ensure the Safety of Imported Seafood
By: Donald Prater, Acting Director of the Office of Food Policy and Response, Steven Bloodgood, Director of the Division of Seafood Safety in the Center for Food Safety and Applied Nutrition, and Dan Solis, Assistant Commissioner for Import Operations
About 94% of the volume of seafood sold in the U.S. is imported from other countries. According to recent federal data, the U.S. imports seafood from more than 144 countries or territories and about 10,000 exporting food facilities, as well as aquaculture farms. Shrimp accounts for the greatest percentage of these imports, followed by salmon and tuna. The FDA requires that imported foods meet the same safety standards as those produced by domestic farms and facilities.
The FDA released a new report, “Activities for the Safety of Imported Seafood,” which outlines the comprehensive approach that the FDA is taking to help ensure the safety of imported seafood, augmenting existing oversight tools with smarter, more efficient technologies and processes.
Guidance Documents
Transition Plan for Medical Devices Issued Emergency Use Authorizations (EUAs) Related to Coronavirus Disease 2019 (COVID-19)
FDA is issuing this guidance to provide its recommendations and expectations to manufacturers of devices that were issued emergency use authorizations (EUAs) related to COVID-19 to transition to normal operations when the declarations that allowed for FDA to issue EUAs under section 564 of the Federal Food, Drug, and Cosmetic Act end. FDA believes the policy set forth in this guidance will help FDA and other stakeholders transition to normal operations and processes.
Transition Plan for Medical Devices That Fall Within Enforcement Policies Issued During the Coronavirus Disease 2019 (COVID-19) Public Health Emergency
FDA is issuing this guidance to provide its recommendations and expectations to manufacturers of devices that fall within certain enforcement policies issued during the COVID-19 public health emergency to transition to normal operations when the public health emergency declaration related to COVID-19 under section 319 of the Public Health Service Act ends. FDA believes the policy set forth in this guidance will help FDA and other stakeholders transition to normal operations and processes.
View all Official FDA Guidance Documents and other Regulatory Guidance
You can search for documents using key words, and you can narrow or filter your results by product, date issued, FDA organizational unit, type of document, subject, draft or final status, and comment period.
ICYMI!
Mammography: What You Need to Know
Mammograms continue to be the best primary tool for breast cancer screening. The FDA, along with some FDA-approved state certifying agencies, certify facilities to perform mammography. The FDA also clears, approves, and authorizes new mammography devices for sale in the U.S.
Congress enacted the Mammography Quality Standards Act (MQSA) in 1992 to ensure all women have access to quality mammography for the detection of breast cancer in its early, most treatable stages. Always look for the MQSA certificate at the mammography facility, which is required to be displayed and indicates that the facility meets the national baseline standards for mammography.
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Webinars and Virtual Workshops
Generic Drugs Forum (GDF) 2023: Celebrating 10 Years of the GDF
April 12 - 13, 2023
Day 1: - ET
Day 2: -
The Generic Drugs Forum (GDF) is an annual, two-day virtual event that offers attendees the opportunity to hear from FDA subject matter experts from every part of the generic drug assessment program. The goal of the forum is to provide information to aid potential and current applicants by offering practical advice and taking a deep dive into the Abbreviated New Drug Application (ANDA) assessment process.
This year’s theme is Celebrating 10 Years of GDF and presentations will focus on hot topics such as GDUFA III updates, information and technology, and complex generics.
FDA’s Proposed New Requirements for Tobacco Product Manufacturing Practices
April 12, 2023; 9:30 AM - 5:00 PM ET
FDA will hold a public oral hearing to provide stakeholders with an opportunity to share their comments on the proposed rule: “Requirements for Tobacco Product Manufacturing Practice.”
FDA is proposing new requirements for tobacco product manufacturers regarding the manufacture, design, packing, and storage of their products. These proposed requirements would help protect public health by, among other things, minimizing or preventing contamination and limiting additional risks by ensuring product consistency. The public oral hearing will allow FDA to gather additional comments on the proposed rule from stakeholders, including industry, the scientific community, advocacy groups, and the public.
Clinical Trials: The Patient Experience
April 13, 2023; 11:00 AM - 3:00 PM
The FDA’s Center for Biologics Evaluation and Research (CBER) Office of Therapeutic Products (OTP) is hosting a public virtual workshop.
The workshop, Clinical Trials: The Patient Experience, will feature a panel of rare disease patients, caregivers, and advocates who will share their experiences with gene therapy clinical trials. Through participation in clinical trials, patients can help advance the science of gene therapy and further the development of rare disease treatments.
View Upcoming FDA Meetings, Conferences and Workshops
Public meetings involving the FDA: Upcoming events, past meetings, meeting materials, and transcripts
About Us
The Stakeholder Engagement Staff resides within the Office of the Commissioner and falls under the Office of External Affairs. We aim to build stronger relationships with health professional organizations, consumer groups, trade associations, patient advocacy organizations, think tanks/academia, and other stakeholders, in order to better inform our policy making process, identify policy hurdles or stakeholder misconceptions, and create strategic collaborations.
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