FDA

Real talks about #OUD can make a difference. Save a life. Find resources, training, and more to get started at https://lnkd.in/eaE8DRvf. Read the handout to get started. Then share it with your colleagues and administration. #PrescribeWithConfidence #MOUD

As healthcare professionals, staying updated with the latest treatment options for #arthritis is crucial. FDA-approved biosimilars are available and might be a valuable addition to your treatment strategies. These biosimilars have met rigorous standards for safety and efficacy and could be an effective treatment alternative for patients. 🔍 Click here for helpful resources on these medications: https://bit.ly/3W6UvTY #ArthritisAwarenessMonth #Biosimilars #HealthcareInnovation

📢 FDA is announcing a webinar on the reorganization of the Center for Drug Evaluation and Research’s (CDER) Office of Pharmaceutical Quality (OPQ). This reorganization was implemented in January and does not result in any direct or immediate changes for external groups, including drug manufacturers.  View the webinar here ➡ https://lnkd.in/eYdC7t2b

FDA issued a revised final guidance for industry, “Application User Fees for Combination Products,” which explains how combination products may be reviewed in a single application or in separate applications for the constituent parts, as appropriate: https://lnkd.in/eCdMTPe9

Medical device developers, tech innovators, software developers, and academic researchers, join the Digitally-Derived Endpoints for Freezing-of-Gait Detection (DEFoGD) Challenge. Hosted by the Center for Devices and Radiological Health and precisionFDA, the DEFoGD Challenge seeks artificial intelligence (AI) models to identify and predict freezing of gait (FoG) events related to Parkinson’s disease. Phase 1 of the Challenge is underway. The top performing AI models from Phase 1 will advance and be evaluated against validated FoG data in Phase 2. Submissions will be accepted through August 2, 2024. Join the DEFoGD Challenge today: https://lnkd.in/eTXanqhm

It is estimated that over 16 million people in the United States have some difficulty swallowing, also known as dysphagia. Size and shape of tablets and capsules affect the transit of the product through the pharynx and esophagus and may directly affect a patient’s ability to swallow a particular drug product.   Recent research was conducted by Meredith McGuire, Agm Mostofa, Jihong Shon, Mitchell Frost, Myong Jin Kim, and Karen Li in the Office of Generic Drugs at the FDA to assess current swallowability study designs and assessment methods to inform future best practices. Learn more: https://lnkd.in/eywPPFwZ.

We are pleased to announce organizational changes within the Center for Devices and Radiological Health (CDRH) to help strengthen and better position the Center to meet our mission to protect and promote the public health.  · CDRH is elevating the Office of Communication and Education (OCE) into a Super Office. OCE’s name has changed to the Office of Communication, Information Disclosure, Training and Education (OCITE) to better represent the broad spectrum of their expertise. · Structural changes have occurred within the Office of Product Evaluation and Quality (OPEQ) in both the Office of Clinical Evidence and Analysis (OCEA) and the Office of Health Technology 4 (OHT4): Surgical and Infection Control Devices to help improve efficiencies within the offices and better meet the needs of our customers. https://lnkd.in/enbrFXTE

Missed our Reddit AMA? Don’t worry! You can catch up on all the insightful questions and answers with an FDA Drug Information expert about biosimilars. Head over to r/medicine and check it out: https://bit.ly/3XZ7Miq

FDA plans to upgrade the SE and PMTA submission process: The CTP Portal Next Generation will allow applicants to create, prepare, and submit applications in one place. Submit your feedback and comments beginning July 16 until September 14 at 11:59 p.m. EST: https://lnkd.in/gFvVfhUk The improvements are intended to: ➡ Streamline electronic submission into one system for substantial equivalence (SE) reports and premarket tobacco product applications (PMTA), amendments to previous submissions, and submission of general correspondences; ➡ Introduce a more efficient submission process by eliminating the need for multiple tools, including combining PDF-editing software, FDA’s eSubmitter Desktop Tool, and FDA’s CTP Portal Web application in one place; ➡ Provide tools to expedite data entry, guide applicants to relevant sections, and verify that all required data have been provided by the applicant. Existing CTP Portal accounts will be migrated to the new CTP Portal Next Generation. CTP is committed to ensuring a smooth transition and will provide communication and support leading up to the change, including resources on how to use the new system.

Join FDA and the University of Maryland Center of Excellence in Regulatory Science and Innovation (M-CERSI) on September 6 for a hybrid public workshop, “ADEPT-9: Enhancing Diversity in Therapeutics Development for Pediatric Patients.” The purpose of this workshop is to solicit input from stakeholders on increasing the enrollment of historically underrepresented populations in pediatric clinical studies, and encouraging pediatric clinical study participation that reflects the prevalence of the other disease or condition among demographic subgroups, where appropriate, and other topics. Register today ➡ https://lu.ma/rv4d2d9t