Updates March 17, 2023 - FDA Denies Marketing of Two Vuse Solo Menthol E-Cigarette Products March 16, 2023 - FDA Authorizes Copenhagen Classic Snuff to be Marketed as a Modified Risk Tobacco Product March 14, 2023 - Coronavirus (COVID-19) Update: FDA Authorizes Bivalent Pfizer-BioNTech COVID-19 Vaccine as Booster Dose for Certain Children 6 Months through 4 Years of Age March 14, 2023 - FDA Roundup March 13, 2023 - FDA Approves First Treatment for Rett Syndrome Consumer Updates Know Your Treatment Options for COVID-19 Know your Options.png Patients today have more treatment options in the battle against coronavirus disease. The FDA has approved drug treatments for COVID-19 and has authorized others for emergency use. In addition, many more therapies are being tested in clinical trials to evaluate whether they are safe and effective in combating COVID-19. Talk to your health care professional about available treatment options if you have COVID-19. Your provider will know the best option for you based on your symptoms, risks and health history. Read More Guidance Documents Pharmacogenomic Data Submissions The draft guidance is intended to clarify the contexts in which pharmacogenomic study findings and data must be included in submissions related to investigational new drug applications (INDs), new drug applications (NDAs), and biologics license applications (BLAs) based on the FDA’s regulations. In addition, this document provides recommendations to sponsors and applicants on the format and content of the pharmacogenomic data submissions. Frequently Asked Questions About Medical Foods - Third Edition This guidance is intended to provide industry with a convenient place to find answers to frequently asked questions (FAQs) about medical foods. The responses to these FAQs address common questions about the definition of and regulations for medical foods. 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 mammography-nurse-patient-CU-1600x900.png 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. Read More Webinars and Virtual Workshops Public Workshop: Understanding Priorities for the Development of Digital Health Technologies to Support Clinical Trials for Drug Development and Review March 28 - 29, 2023 Day 1- 1:00 PM - 4:15 PM ET Day 2: 1:00 PM - 4:45 PM ET FDA and the Duke-Robert J. Margolis, MD Center for Health Policy will host the virtual public workshop. The purpose of the public workshop is to understand the priorities for the development of Digital Health Technologies (DHTs) to support clinical drug trials, including accessibility, diversity, and clinical outcomes measures using DHTs. Register Here Immune Globulin Hypersensitivity Reactions: Root Causes and Mitigation; Public Workshop March 30, 2023; 8:30 AM - 4:15 PM ET The overarching workshop goals are to enhance patient safety and preserve product availability. The objectives of the workshop are to share knowledge that will contribute to prevention of lot-specific hypersensitivity reactions, and to seek opinions from scientific experts on: The most likely root cause(s) of reactions Potential recipient risk factors Development of pragmatic in vitro methods to identify plasma units or products that mediate lot-specific hypersensitivity Register Here Understanding the Use of Existing Real-world Data for Medical Product Evaluation March 30, 2023; 3:00 PM - 4:00 PM ET

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