FDA

FDA approves Imfinzi (durvalumab) in combination with platinum-containing chemotherapy as neoadjuvant treatment, followed by single-agent durvalumab as adjuvant treatment after surgery, for the treatment of adult patients with resectable (tumors ≥ 4 cm and/or node positive) non-small cell lung cancer (NSCLC) and no known epidermal growth factor receptor (EGFR) mutations or anaplastic lymphoma kinase (ALK) rearrangements. Imfinzi comes with a warning of severe or fatal immune-mediated adverse reactions including immune-mediated pneumonitis, immune-mediated colitis, immune-mediated hepatitis, immune-mediated endocrinopathies, immune-mediated dermatologic adverse reactions, immune-mediated nephritis and renal dysfunction, solid organ transplant rejection, and immune-mediated pancreatitis. Severe or life-threatening infusion-related reactions have been reported. Fatal and other serious complications can occur in patients who receive allogeneic hematopoietic stem cell transplantation before or after being treated with a PD-1/PD-L1 blocking antibody. Imfinzi can cause fetal harm. Advise females of reproductive potential of the potential risk to a fetus and use of effective contraception. The most common adverse reactions (≥20%) were anemia, nausea, constipation, fatigue, musculoskeletal pain, and rash. Of the patients who received neoadjuvant durvalumab, 1.7% were unable to receive surgery due to adverse reactions compared with 1% in the placebo arm. Learn more in the FDA-approved prescribing information below and at: https://lnkd.in/guD4-Unq

FDA approved Miplyffa (arimoclomol), an oral medication for the treatment of Niemann-Pick disease, type C (NPC). Miplyffa, in combination with the enzyme inhibitor miglustat, is approved to treat neurological symptoms associated with NPC in adults and children 2 years of age and older. Miplyffa is the first drug approved by the FDA to treat NPC. The prescribing information for Miplyffa contains a warning for hypersensitivity reactions including hives and angioedema (swelling under the skin). Individuals experiencing these adverse reactions should stop using the drug. Females who are pregnant or plan to become pregnant should not use Miplyffa. The most common side effects of Miplyffa include upper respiratory tract infection, diarrhea and decreased weight. Learn more: https://lnkd.in/gfMQMSE9

Today, FDA approved a medication for self- or caregiver-administration for the prevention of influenza disease caused by influenza virus subtypes A and B in individuals 2 through 49 years of age. https://lnkd.in/eB84ACS5

The FDA has updated three ASCA guidances to improve the ASCA program based on lessons learned from its pilot phase. When final, these guidances will replace the three ASCA Pilot guidances published September 25, 2020. Learn more about the guidances and how ASCA reduces regulatory burden: https://lnkd.in/e7WqV4yJ

On Oct. 21, FDA and NIH will hold a joint public meeting, “Advancing Smoking Cessation: FDA and NIH Priorities.” The meeting will be presented in a hybrid format, with an option for virtual attendance. Submit your request to provide an in-person comment and register:️ https://lnkd.in/dfvQquCR

Are you a healthcare professional and want to learn more about the current state of the opioid crisis and what we can do to prevent drug overdoses and reduce deaths? Join us on Wednesday, Sept. 25 at 11 a.m. EDT to hear directly from the FDA, SAMHSA and NIH about the latest in overdose prevention. https://lnkd.in/eQmRtW_p

Dr. Patrizia Cavazzoni, Director of the FDA Center for Drug Evaluation and Research, will be speaking at the 2024 ASA Biopharmaceutical Section Regulatory-Industry Statistics Workshop on Thursday, September 26 on the intersection of statistics, data science, and AI in drug development. Harnessing the power of the these tools is critical for the FDA’s mission to support innovation that improves patient access to safe and effective treatments.

We have issued a draft guidance to help industry review analytical chemistry studies for assessing the biocompatibility of medical devices for patients and check that they are done in a consistent and reliable way. This draft guidance also provides recommendations on how to collect and report chemical data for medical devices. Learn more: https://lnkd.in/ew3G-UKy We welcome your comments. Submit them under docket number FDA-2024-D-4165 by November 18, 2024 to ensure the FDA considers comments on this draft guidance before we begin work on the final version of the guidance. https://lnkd.in/eAMYxR5w  

Join this free, hybrid public meeting with FDA and the Reagan-Udall Foundation for the FDA that will bring together rare disease patient advocates, academic researchers, regulated industry, and other key stakeholders to discuss the Rare Disease Innovation Hub. You may submit comments to the docket and request to make an oral presentation during the meeting during event registration. ➡️ Don’t miss your opportunity to register: https://lnkd.in/epxcdyZk

REMINDER - Register for the FDA's public meeting on the Development of an Enhanced Systematic Process for FDA’s Post-Market Assessment of Chemicals in Food. The September 25th meeting will be held in-person at the FDA White Oak Campus, 10903 New Hampshire Avenue, Silver Spring, MD 20993 with an option for virtual participation as well. The meeting agenda, information on how to submit comments, and sign-up are available. https://lnkd.in/eZeWKMfQ #ChemicalsinFood