What's New: Drugs RSS Feed http://www.fda.gov/ en Non-Compliance Letters under 505B(d)(1) of the Federal Food, Drug, and Cosmetic Act http://www.fda.gov/drugs/development-resources/non-compliance-letters-under-505bd1-federal-food-drug-and-cosmetic-act Section 505B(d)(1) requires FDA to send a PREA Non-Compliance letter to sponsors who have failed to submit their pediatric assessments required under PREA by the final due date, have failed to seek or obtain a deferral or deferral extension, or have failed to request approval for a required pediatri Mon, 20 May 2024 15:55:52 EDT FDA http://www.fda.gov/drugs/development-resources/non-compliance-letters-under-505bd1-federal-food-drug-and-cosmetic-act Generic Drug Facilities, Sites and Organization Lists http://www.fda.gov/industry/generic-drug-user-fee-amendments/generic-drug-facilities-sites-and-organization-lists Generic Drug Facilities, Sites and Organization Lists Mon, 20 May 2024 15:55:12 EDT FDA http://www.fda.gov/industry/generic-drug-user-fee-amendments/generic-drug-facilities-sites-and-organization-lists About CDER Center for Clinical Trial Innovation (C3TI) http://www.fda.gov/about-fda/cder-center-clinical-trial-innovation-c3ti/about-cder-center-clinical-trial-innovation-c3ti C3TI brings together collective expertise and activities to foster integration and coordination across the different ongoing projects and initiatives within CDER around clinical trial innovation, and to maximize their collective impact on drug development productivity and clinical trial subject. Mon, 20 May 2024 14:30:10 EDT FDA http://www.fda.gov/about-fda/cder-center-clinical-trial-innovation-c3ti/about-cder-center-clinical-trial-innovation-c3ti Prescribe with Confidence http://www.fda.gov/drugs/drug-safety-and-availability/prescribe-confidence Primary care providers can work together with their patients to manage opioid use disorder (OUD) with the help of medications for opioid use disorder (MOUD). Mon, 20 May 2024 13:58:03 EDT FDA http://www.fda.gov/drugs/drug-safety-and-availability/prescribe-confidence FDA Promotes Clinical Trial Innovation http://www.fda.gov/news-events/fda-voices/fda-promotes-clinical-trial-innovation As the U.S. Food and Drug Administration observes Clinical Trials Day, we reflect on the progress made and the widespread efforts underway to advance clinical trial innovation. Mon, 20 May 2024 13:50:29 EDT FDA http://www.fda.gov/news-events/fda-voices/fda-promotes-clinical-trial-innovation What's New Related to Drugs http://www.fda.gov/drugs/news-events-human-drugs/whats-new-related-drugs Want to know what's new on drugs from FDA? This page provides quick links to the latest on a variety of topics including: drug approvals, safety warnings, drug shortages, etc. Mon, 20 May 2024 13:35:46 EDT FDA http://www.fda.gov/drugs/news-events-human-drugs/whats-new-related-drugs Primary Care Providers Can Prescribe with Confidence http://www.fda.gov/drugs/prescribe-confidence/primary-care-providers-can-prescribe-confidence Primary care providers can work together with their patients to manage opioid use disorder (OUD) with the help of medications for opioid use disorder (MOUD). Mon, 20 May 2024 13:29:39 EDT FDA http://www.fda.gov/drugs/prescribe-confidence/primary-care-providers-can-prescribe-confidence Partner with Us to Help More Providers Prescribe with Confidence http://www.fda.gov/drugs/prescribe-confidence/partner-us-help-more-providers-prescribe-confidence Partner with the FDA’s Center for Drug Evaluation and Research to encourage providers to manage opioid use disorder with MOUD. Mon, 20 May 2024 13:29:30 EDT FDA http://www.fda.gov/drugs/prescribe-confidence/partner-us-help-more-providers-prescribe-confidence Recently Issued Guidance Documents http://www.fda.gov/vaccines-blood-biologics/biologics-guidances/recently-issued-guidance-documents This page lists Recently Issued CBER and Cross-Center Guidance Documents. Mon, 20 May 2024 12:41:20 EDT FDA http://www.fda.gov/vaccines-blood-biologics/biologics-guidances/recently-issued-guidance-documents CDER Center for Clinical Trial Innovation (C3TI) http://www.fda.gov/about-fda/center-drug-evaluation-and-research-cder/cder-center-clinical-trial-innovation-c3ti Enable and amplify existing and future CDER clinical trial innovation through enhanced communication and collaboration Mon, 20 May 2024 12:25:52 EDT FDA http://www.fda.gov/about-fda/center-drug-evaluation-and-research-cder/cder-center-clinical-trial-innovation-c3ti Biosimilar Product Information http://www.fda.gov/drugs/biosimilars/biosimilar-product-information This page includes a chart of the approved biosimilar and interchangeable products. The approval of biosimilar products can improve access to care for patients by increasing the number of medication options and potentially lower costs. Mon, 20 May 2024 10:45:11 EDT FDA http://www.fda.gov/drugs/biosimilars/biosimilar-product-information Notable Approvals | Drugs http://www.fda.gov/drugs/news-events-human-drugs/notable-approvals-drugs News about human drug-related approvals Mon, 20 May 2024 10:39:54 EDT FDA http://www.fda.gov/drugs/news-events-human-drugs/notable-approvals-drugs FDA approves first interchangeable biosimilars to Eylea to treat macular degeneration and other eye conditions http://www.fda.gov/drugs/news-events-human-drugs/fda-approves-first-interchangeable-biosimilars-eylea-treat-macular-degeneration-and-other-eye FDA approved Yesafili (aflibercept-jbvf) and Opuviz (aflibercept-yszy) as interchangeable biosimilars to Eylea (aflibercept). Mon, 20 May 2024 10:39:03 EDT FDA http://www.fda.gov/drugs/news-events-human-drugs/fda-approves-first-interchangeable-biosimilars-eylea-treat-macular-degeneration-and-other-eye User Fee Lists http://www.fda.gov/industry/generic-drug-user-fee-amendments/user-fee-lists Fiscal Year (FY) 2017 GDUFA facility fees are due on October 3, 2016. Fri, 17 May 2024 16:21:42 EDT FDA http://www.fda.gov/industry/generic-drug-user-fee-amendments/user-fee-lists Emergency Use Authorizations for Drugs and Non-Vaccine Biological Products http://www.fda.gov/drugs/emergency-preparedness-drugs/emergency-use-authorizations-drugs-and-non-vaccine-biological-products Emergency Use Authorizations for Drugs and Non-Vaccine Biological Products Fri, 17 May 2024 16:12:58 EDT FDA http://www.fda.gov/drugs/emergency-preparedness-drugs/emergency-use-authorizations-drugs-and-non-vaccine-biological-products FDA Roundup: May 17, 2024 http://www.fda.gov/news-events/press-announcements/fda-roundup-may-17-2024 The U.S. Food and Drug Administration is providing an at-a-glance summary of news from around the agency. Fri, 17 May 2024 15:46:25 EDT FDA http://www.fda.gov/news-events/press-announcements/fda-roundup-may-17-2024 WITHDRAWN: FDA grants accelerated approval to infigratinib for metastatic cholangiocarcinoma http://www.fda.gov/drugs/resources-information-approved-drugs/withdrawn-fda-grants-accelerated-approval-infigratinib-metastatic-cholangiocarcinoma Hematology / Oncology Fri, 17 May 2024 15:24:09 EDT FDA http://www.fda.gov/drugs/resources-information-approved-drugs/withdrawn-fda-grants-accelerated-approval-infigratinib-metastatic-cholangiocarcinoma July - September 2023 | Potential Signals of Serious Risks/New Safety Information Identified by the FDA Adverse Event Reporting System (FAERS) http://www.fda.gov/drugs/questions-and-answers-fdas-adverse-event-reporting-system-faers/july-september-2023-potential-signals-serious-risksnew-safety-information-identified-fda-adverse July - September 2023 | Potential Signals of Serious Risks/New Safety Information Identified by the FDA Adverse Event Reporting System (FAERS) Fri, 17 May 2024 15:12:19 EDT FDA http://www.fda.gov/drugs/questions-and-answers-fdas-adverse-event-reporting-system-faers/july-september-2023-potential-signals-serious-risksnew-safety-information-identified-fda-adverse C3TI Compass (Knowledge Repository) | Glossary http://www.fda.gov/about-fda/cder-center-clinical-trial-innovation-c3ti/c3ti-compass-knowledge-repository-glossary Glossary of terms for C3TI's Compass Knowledge Repository Fri, 17 May 2024 15:02:00 EDT FDA http://www.fda.gov/about-fda/cder-center-clinical-trial-innovation-c3ti/c3ti-compass-knowledge-repository-glossary Protectores solares: Cómo ayudar a proteger su piel del sol http://www.fda.gov/drugs/understanding-over-counter-medicines/protectores-solares-como-ayudar-proteger-su-piel-del-sol Protectores solares: Cómo ayudar a proteger su piel del sol Fri, 17 May 2024 15:01:45 EDT FDA http://www.fda.gov/drugs/understanding-over-counter-medicines/protectores-solares-como-ayudar-proteger-su-piel-del-sol