FDA

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

Drug sponsors and researchers: Last year's FDA, CDER, and JHU CERSI workshop focused on the challenges in designing and analyzing rare disease clinical trials. The event provided valuable insights into innovative methodologies and collaborative strategies. Review the workshop's key takeaways and materials here: https://lnkd.in/eUBGgtPf

Are your patient's medications available as biosimilars? The FDA has approved over 50 biosimilar medications for conditions like diabetes, osteoporosis, and various cancers. These #biosimilars are safe, effective, and offer more treatment options for patients. Discover if these medications are on the list and explore their treatment benefits. More information here: https://bit.ly/4bSK7Uk #HealthcareInnovation #AffordableMedicine

HKS is proud to partner with the FDA on the launch of its groundbreaking new initiative, Home as a Health Care Hub. Swipe thru below to learn how this project will transform our homes and advance health equity for all people in the U.S. 🔽   Interested in getting a better understanding about the Hub? Join the virtual public meeting hosted by the FDA on July 25 from 12 - 4 p.m. ET. HKS' very own Upali Nanda, along with other stakeholders, will explore how the home environment is emerging as the focus of care. Register: https://hks.onl/3WhmSye #virtualreality #healthcaredesign #health #design #architecture

Did you miss the workshop on Enhancing Adoption of Innovative Clinical Trial Approaches? Trying to keep pace with the ever-changing drug development landscape? This public workshop that Duke-Margolis Institute for Health Policy convened with FDA explored opportunities to support and advance innovation in clinical trials. Check out the summary which includes the recommendations from the panel discussion about how to foster the adoption of clinical research innovations: https://lnkd.in/eCJnR-UJ Other event information is also available online: https://lnkd.in/eCUA9PcK

Join us for a virtual listening meeting on 9/20 to hear patient & care partner perspectives on safety considerations for #genetherapy treatments for #rarediseases & participation in long-term studies after receiving gene therapy. Request to speak by 8/30: https://bit.ly/3XUEQrP