FDA Roundup: September 19, 2023

FDA News Release

• For Immediate Release: September 19, 2023

Today, the U.S. Food and Drug Administration is providing an at-a-glance summary of news from around the agency: 

• Today, the FDA informed the public in the Prostate Cancer Symptoms, Tests and Treatments Consumer Update that the agency regulates certain tests and treatments for prostate cancer to ensure they are safe and effective. Prostate cancer is the most common cancer among men in the U.S. and the second most common cause of cancer-related deaths. And African American men are more likely to get prostate cancer and twice as likely to die from the disease than men of other races.
• Today, the FDA published the FDA Voices: “FDA’s IT Strategy: Unlocking Potential, Leading Transformation,” by Vid Desai, Chief Information Officer, and Jessica N. Berrellez, Executive Officer. The FDA has released the “FDA Information Technology Strategy for Fiscal Years 2024 to 2027.” The agency considers the new IT Strategy more than a roadmap: it’s a shared vision that unites the FDA’s IT portfolio and will foster innovation, enhance public health outcomes, and lead the FDA into a new era of scientific and technological advancement.
• On Monday, the FDA issued the draft guidance, “Demonstrating Substantial Evidence of Effectiveness Based on One Adequate and Well-Controlled Clinical Investigation and Confirmatory Evidence.” This guidance (the Confirmatory Evidence guidance) complements the draft guidance for industry “Demonstrating Substantial Evidence of Effectiveness for Human Drug and Biological Products” (December 2019) and the “Guidance for industry Providing Clinical Evidence of Effectiveness for Human Drug and Biological Products” (May 1998). 
  The Confirmatory Evidence guidance supplements and expands the recommendations in the 2019 Substantial Evidence of Effectiveness draft guidance by providing further detail on the use of data drawn from one or more sources to support the results of one adequate and well-controlled clinical investigation. It also provides examples of types of data that could be considered confirmatory evidence. This guidance emphasizes the importance of early engagement with the agency for sponsors that intend to establish substantial evidence of effectiveness with one adequate and well-controlled clinical investigation and confirmatory evidence.
• On Monday, the FDA issued a draft guidance for industry entitled, “Regulatory Considerations for Prescription Drug Use-Related Software.” Digital health technologies used with prescription drugs can potentially offer new ways to help treat patients. Software, including those designed for mobile apps, are used for health-related purposes, such as assisting patients with tracking their own drug ingestion, allowing health care practitioners to monitor patients taking a prescription drug, or providing information on how to use a drug. Digital health technologies, like prescription drug-use-related software, may provide insight to patients, caregivers, and health care providers (collectively known as “end-users”) about a patient’s drug use. In response to comments received from the FDA’s November 2018 proposed framework “Prescription Drug-Use-Related Software,” the agency is issuing the draft guidance to clarify how the FDA will apply its drug labeling authorities to end-user output of prescription drug-use related software, how the FDA-required labeling will describe certain prescription drug-use-related software, and when and how to submit end-user output to the FDA. To learn more, please read the CDER Conversation on software associated with prescription drug use.
• On Friday, FDA announced a call for comments on its newly developed draft electronic submission portal (Cosmetics Direct) and paper forms (Forms FDA 5066 and 5067). The submission portal and paper forms are part of FDA’s implementation of the new registration and listing requirements mandated by the Modernization of Cosmetics Regulation Act of 2022 (MoCRA). Draft screenshots of the electronic system are available here for review and comments. For more information, see the Federal Register Notice and Registration & Listing of Cosmetic Product Facilities and Products webpage.
• On Friday, the FDA approved Ojjaara (momelotinib, GlaxoSmithKline), a kinase inhibitor indicated for the treatment of intermediate or high-risk myelofibrosis (MF), including primary MF or secondary MF [post-polycythemia vera (PV) and post-essential thrombocythemia (ET)], in adults with anemia. The most common adverse reactions were dizziness, fatigue, bacterial infection, hemorrhage, thrombocytopenia, diarrhea and nausea. View the full prescribing information for Ojjaara.   
• On Friday, the FDA issued a reminder to all medical device submitters that starting October 1, 2023, all 510(k) submissions, unless exempted, must be submitted as electronic submissions using eSTAR through the CDRH Portal as noted in the Electronic Submission Template for Medical Device 510(k) Submissions final guidance. eSTAR is the only available electronic submission template to facilitate the preparation of 510(k) electronic submissions. Use of eSTAR for all 510(k) submissions is part of the FDA’s ongoing commitment to update the 510(k) Program.    
• On Friday, the FDA published a list of digital health frequently asked questions to help answer common questions about bringing safe and effective digital health technologies to market. Digital health technologies are rapidly advancing, and so is the FDA as it continues to help developers bring safe, effective, and innovative technologies to market.