The United States Food and Drug Administration (FDA) has issued its weekly regulatory update for stakeholders. You can read the FDA regulatory update for stakeholders below.
January 13, 2025
Dear Colleague,
The FDA works to safeguard the public against potential health risks, ensures the safety and efficacy of medical products, and the safety of our nation’s food supply and cosmetics. The Public Engagement Staff is responsible for engaging, educating and communicating with external partners including patients, caregivers, health care providers, consumers, academia and trade associations on the agency’s policy priorities. We also recognize the invaluable work of our external partners in achieving these goals. Your partnership, knowledge and engagement in the public health space are appreciated.
Pulse Oximeters and Oxygen Concentrators: What to Know About At-Home Oxygen Therapy
To survive, we need oxygen going from our lungs to the cells in our body. Sometimes the amount of oxygen in our blood can fall below normal levels. Asthma, lung cancer, chronic obstructive pulmonary disease (COPD), the flu, and COVID-19 are some of the health issues that may cause oxygen levels to drop. When the levels are too low, we may need to take extra oxygen, known as oxygen therapy.
One way to get extra oxygen into the body is by using an oxygen concentrator. Oxygen concentrators are medical devices required to be sold and used only with a prescription.
Many people of all ages take medications. Keeping track of when, how and why you use medications is important for your health and safety.
A medication list is a tool to help you keep track of all the prescription medications, over-the-counter (OTC) drugs, vitamins and supplements that you take. Keeping a medication list helps health care professionals know about your current health and minimize medication errors and adverse drug interactions. It can be a lifesaving tool, especially during an emergency.
CDER Brings Many Safe and Effective Therapies to Patients and Consumers in 2024
By: Patrizia Cavazzoni, M.D., Director, Center for Drug Research and Evaluation
Each year, the U.S. Food and Drug Administration’s Center for Drug Evaluation and Research (CDER) evaluates and, as appropriate, approves many therapies for patients and consumers. CDER publishes an annual New Drug Therapy Approvals report to showcase these novel approvals and the regulatory tools used to streamline the review and approval process.
As in previous years’ reports, the 2024 New Drug Therapy Approvals report features drug approvals that CDER considers likely to have a significant impact on public health. The 2024 report includes approvals for therapies that collectively treat a wide range of conditions, including a first-in-class drug for schizophrenia, three novel antibiotics and new drugs for many types of cancer.
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.
FDA’s Knowledge-aided Assessment and Structured Application (KASA) initiative is a creative regulatory approach for modernizing quality assessment and enhancing submission format. KASA is designed to capture and manage knowledge during the lifecycle of a drug product; establish rules and algorithms to facilitate risk identification, mitigation, and communication; perform computer-aided analyses of applications for a comparison of regulatory standards and quality risk across the repository of approved drug products and facilities; and provide a structured assessment that minimizes text-based narratives and summarization of information provided in applications.
The purpose of this meeting is, in part, to fulfill the Center’s Medical Device User Fee Amendments 2022 (MDUFA V) commitment to update the public on the CDRH’s Real-World Evidence (RWE) program activities.
During this webinar, leaders from across OTP will provide information about how the office is helping to advance cell and gene therapy product development through innovation, engagement, and collaboration.
Public meetings involving the FDA: Upcoming events, past meetings, meeting materials, and transcripts
About Us
The Public 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, patients and patient advocacy organizations, consumer groups, trade associations, think tanks and academia, and other interested parties, in order to better inform our policy making process, identify policy hurdles or misconceptions, and create strategic collaborations. For more information, please contact us at: PublicEngagement@fda.hhs.gov. For patient specific inquiries, please contact us at: Patients Ask FDA.
January 13, 2025
Each year, the U.S. Food and Drug Administration’s Center for Drug Evaluation and Research (CDER) evaluates and, as appropriate, approves many therapies for patients and consumers. CDER publishes an annual New Drug Therapy Approvals report to showcase these novel approvals and the regulatory tools used to streamline the review and approval process. 