FDA Roundup: December 05, 2023

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Dec 05, 2023, 17:37 ET

SILVER SPRING, Md., Dec. 5, 2023 /PRNewswire/ -- Today, the U.S. Food and Drug Administration is providing an at-a-glance summary of news from around the agency:

Today, registration opened for the FDA's virtual Rare Disease Day on Friday, March 1, 2024. This year's Rare Disease Day is dedicated to patients and health care professionals. Panels will discuss efforts to address the unique challenges with developing treatments for rare diseases, as well as the FDA's efforts to promote new medical products for patients with rare diseases.

Free continuing education (CE) credit will be available for eligible health care professionals. See Rare Disease Day 2024 for more information and details on how to register.
On Monday, the FDA published the FDA Voices: "The Importance of Clinical Trial Transparency and FDA Oversight," by Robert M. Califf, M.D., Commissioner of Food and Drugs. The FDA takes its oversight of clinical trials seriously and encourages voluntary compliance with the ClinicalTrials.gov requirements. We communicate transparency expectations and obligations under the law and use a risk-based approach to prioritize compliance and enforcement actions for the violations that pose the greatest risk to public health. The FDA is committed to promoting clinical trial transparency and will continue to advance our compliance activities related to the ClinicalTrials.gov database.
On Friday, the FDA granted accelerated approval to pirtobrutinib (Jaypirca, Eli Lilly and Company) for adults with chronic lymphocytic leukemia or small lymphocytic lymphoma (CLL/SLL) who have received at least two prior lines of therapy, including a BTK inhibitor and a BCL-2 inhibitor. The most common adverse reactions (≥ 20%), excluding laboratory terms, were fatigue, bruising, cough, musculoskeletal pain, COVID-19, diarrhea, pneumonia, abdominal pain, dyspnea, hemorrhage, edema, nausea, pyrexia, and headache. View the prescribing information for Jaypirca.
On December 12-13, 2023, the National Academies of Sciences, Engineering, and Medicine, with the Forum on Drug Discovery, Development and Translation and the Forum on Neuroscience and Nervous System Disorders, will host a virtual public workshop titled, "Adult Attention-Deficit/Hyperactivity Disorder: Diagnosis, Treatment, and Implications for Drug Development."

This workshop will provide a venue for professionals who typically diagnose adult attention-deficit/hyperactivity disorder (ADHD), drug developers, researchers, people with lived experience, and other stakeholders to discuss the diagnosis and treatment of adults with ADHD, explore challenges and opportunities for drug development, and consider strategies for assessing the risks and benefits of ADHD medication treatment in adult populations. The workshop is supported, in part, through a grant (PAR-23-072) from the Center for Drug Evaluation and Research at the FDA. Registration is available here.

Additional Resources:

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The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation's food supply, cosmetics, dietary supplements, radiation-emitting electronic products, and for regulating tobacco products.

SOURCE U.S. Food and Drug Administration