FDA Stakeholder Update - December 5, 2019

Dear Colleague,

FDA's Stakeholder Engagement Staff works to provide you with up-to-date information to further our commitment to advance public health and well-being.

FDA Announcements

FDA launches app for health care professionals to report novel uses of existing medicines for patients with difficult-to-treat infectious diseases The FDA today announced the global launch of CURE ID, an internet-based repository that will allow the clinical community to report their experiences treating difficult-to-treat infectious diseases with novel uses of existing FDA-approved drugs through a website, a smartphone or other mobile device. The platform enables the crowdsourcing of medical information from health care providers to guide potentially life-saving interventions and facilitate the development of new drugs for neglected diseases. The repository is a collaboration between the FDA and the National Center for Advancing Translational Sciences (NCATS), which is part of the National Institutes of Health (NIH). [12/05/2019]

FDA in Brief

FDA issues warning letter for products illegally marketed for the treatment of health conditions, including opioid withdrawal symptoms The FDA issued a warning letter to EPH Technologies, Inc. of New Mexico for marketing and selling unapproved and misbranded drugs, including Detoxoplex as a treatment for opioid withdrawal symptoms. The company is also marketing several other products with unproven claims that they can treat medical conditions, including migraines and dizziness. Because these products have not been demonstrated to be safe and effective for these conditions, they are unapproved new drugs under the Federal Food, Drug, and Cosmetic Act.  [11/26/2019]

Request for Comment Dear Health Care Provider Letters: Improving Communication of Important Safety Information by December 23, 2019 This information collection supports recommendations found in the Agency guidance document. The guidance provides instruction to industry and FDA staff on the content and format of Dear Health Care Provider (DHCP) letters. These letters are sent by manufacturers or distributors to health care providers to communicate an important drug warning, a change in prescribing information, or a correction of misinformation in prescription drug promotional labeling or advertising.

Public Meetings and Workshops

Evolving Role of Artificial Intelligence in Radiological Imaging Date: February 25-26, 2020 Time: 08:00 AM - 05:30 PM EST Agenda: Emerging applications of Artificial Intelligence (AI) in radiological imaging, including devices intended to automate the diagnostic radiology workflow and enable guided image acquisition; benefits and risks associated with using AI in radiological imaging; and best practices for the validation of AI-automated radiological imaging software and image acquisition devices to assess safety and effectiveness. This workshop is an opportunity for stakeholders to provide feedback to the FDA on the following topics: Additional Information: Docket FDA-2019-N-5592 for the Public Workshop is open until March 26, 2020 for commenting. Oncologic Drugs Advisory Committee Meeting Date: December 17-18, 2019 Time: 08:00 AM - 05:00 PM EST Location: Great Room of FDA’s White Oak Campus in Silver Spring, MD Agenda: The committee will discuss two applications. First, biologics license application (BLA) 761136/Original 2, for luspatercept for injection, an application submitted by Celgene Corporation. The proposed indication for this product is for the treatment of adult patients with very low- to intermediate-risk myelodysplastic syndromes -associated anemia who have ring sideroblasts and require red blood cell transfusions. Second, new drug application (NDA) 211723 for tazemetostat tablets, submitted by Epizyme, Inc. The proposed indication for this product is for the treatment of patients with metastatic or locally advanced epithelioid sarcoma not eligible for curative surgery. Public Workshop on Developing Novel Therapies for Stimulant Use Disorder Date: December 16, 2019 Time: 09:00 AM - 04:30 PM EST Location: Marriott Metro Center - Washington, DC Agenda: Through a cooperative agreement with FDA, Duke-Margolis Center for Health Policy is hosting this public workshop to examine the complexities of stimulant use disorder with a focus on methamphetamine and cocaine abuse. The goals of this workshop are to explore emerging trends in illicit and prescription stimulant abuse, review drug development paradigms for novel treatments, and explore potential innovative therapies for stimulant use disorder. Consumer Update Now’s Still a Good Time to Get Your Flu Vaccine Haven’t had your flu vaccine yet? It’s not too late. And there are still good reasons to get one. Flu — more formally known as influenza — is a serious viral disease that can lead to hospitalization and even death. Every flu season is different, and the substantial health impacts can vary widely from season to season. Your best defense is vaccination, which provides important protection from influenza illness and its potential complications. The FDA plays a key role in ensuring that safe and effective flu vaccines are available every flu season. [11/26/2019]